MDCG 2024-15 is the first guidance document published by the Medical Device Coordination Group in December 2024. This document provides instructions on how to submit…
New MDCG Guidance on Master UDI-DI for contact lenses
The Medical Device Coordination Group (MDCG) just published a new MDCG guidance document on the implementation of the Master UDI-DI solution for contact lenses. MDCG…
New Product Liability Directive (PLD): What is changing?
On 18 November 2024, Directive (EU) 2024/2853 on liability for defective products (new PLD) was published in the Official Journal of the EU. The new…
Swiss Federal Council votes in favour of IvDO amendments
On 20 November 2024, the Swiss Federal Council voted in favour of certain amendments to the Swiss IVD Ordinance. The changes address various aspects, from…
European Commission publishes Q&A on EUDAMED roll-out
On 21 November 2024, the European Commission released a Q&A document on the application of Regulation (EU) 2024/1860, addressing the gradual roll-out of EUDAMED. Article…
MHRA opens consultation on future UK Medical Devices Regulations
The Medicines and Healthcare products Regulatory Agency (MHRA) just launched a consultation on the future UK regulatory framework for medical devices (UK MDR). The deadline…
Revised Q&A on vigilance terms and concepts
The MDCG Group (Medical Device Coordination Group) just released a revised version of MDCG 2023-3. This guidance document provides answers to different questions concerning vigilance…
MDCG: Ethylene Oxide in medical devices and Borderline Classification
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and…
Notification for interruptions or discontinuations in the supply of medical devices
In its recent Regulation (EU) 2024/1860, the European Commission introduced amendments to the Medical Devices Regulations (MDR and IVDR). One of the main novelties of…
European Parliament votes in favour of MDR & IVDR resolution
Today, 23 October 2024, the European Parliament votes in favour of a resolution to update the Medical Devices Regulations within 180 days. The motion passed…
Updated MDCG 2021-25 on MDR legacy requirements
MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26…
Harmonised standards for aseptic processing and clinical performance studies
On 9 October 2024, the European Commission published new harmonised standards in support of the EU medical devices Regulations (MDR and IVDR). These new standards…
New Guidance on qualification of IVDs
The Medical Device Coordination Group (MDCG) released MDCG 2024-11, a new guidance to support the qualification of in vitro diagnostic medical devices and assess whether…
MDR: 50 Notified Bodies on NANDO!
The NANDO database now includes the NEOEMKI LLC, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to…
Transitional provisions for Class D IVDs: Updates to MDCG 2021-4
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
Important deadline for legacy manufacturers: 26 September 2024
By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with a notified body for MDR CE certification. Before this deadline,…
IVDR: 13th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation…
Public consultation on common specifications for IVDs
From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16…
Switzerland: alignment with IVDR extension and Swissdamed implementation
On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment with the EU extension for legacy IVDs, labelling simplification for…
Actors can now register to Swissdamed!
Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is active! Manufacturers, importers, authorised representatives can now register through the…
Artificial Intelligence Act just released
Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the European Union. Regulation (EU) 2024/1689 sets harmonised…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…
Updated guidance on classification rules for IVDs
MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its third revision. The second update came in February 2023 with…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on standardisation for medical devices, first published in 2021. In the…
MDCG on clinical evaluation of orphan medical devices
Today, 25 June 2024, the MDCG (Medical Device Coordination Group) published a guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10). An orphan…
Annex XVI devices: MDR requirements and deadlines
To be placed on the EU market, certain products without an intended medical purpose have to comply with the Medical Devices Regulation (MDR). Annex XVI…
Council formally adopts amendments to MDR and IVDR
Today, 30 May 2024, the Council formally adopted the new rules to amend the Medical Devices Regulations, the MDR and IVDR. The updates bring new…
MDCG on appropriate surveillance for legacy devices
On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of MDCG 2022-4. This document is a guidance on appropriate surveillance…
Future UK recognition of devices from EU, US, Canada, and Australia
The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…
New REACH restrictions on D4, D5, and D6 apply to medical devices and IVDs
On 17 May 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328 amending REACH regarding the use of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane…
MDR: 49th Notified Body on NANDO!
The NANDO database now includes the first Austrian MDR Notified Body, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical…
MDR: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A.Ş. is overall…
MDR: 47th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745…
MDR national implementation law: Portugal
On April 5, 2024, the Portuguese Decree-Law no. 29/2024 was officially published to enforce Regulation (EU) 2017/745 on medical devices. While additional acts are anticipated…
Parliament votes in favor of IVDR legacy extension and EUDAMED mandatory use
On 25 April 2024, the European Parliament voted in favour of the Proposal to extend the transitional provisions for IVDR legacy devices, introduce a gradual…
MDR: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the 46th EU Notified Body notified under Regulation (EU) 2017/745 on…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the Investigator’s Brochure for clinical investigations of medical devices (MDCG 2024-5).…
New MDCG guidance on safety reporting in IVDs performance study
The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting in performance studies of in-vitro diagnostic medical devices: MDCG 2024-4.…
MDR: 45th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745…
MDR & IVDR national requirements: France
France has incorporated the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) into the national framework through the adoption…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…
EU and Switzerland start negotiations to deepen bilateral relations
The European Commission and the Swiss Confederation announced on 18 March the start of negotiations on a broad package of measures. This decision comes after…
Notified Bodies survey on MDR/IVDR certifications and applications – March update
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
Parliament approved the Artificial Intelligence Act
Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act. In December 2023, Members of the Parliament endorsed the AI…
MDCG Guidance on Clinical Investigation Plan
The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the content of the clinical investigation plan for clinical investigations of…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body AB is the 44th EU Notified Body notified under the…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the MedTech Regulatory Reform Webinar. This online webinar provided insight into…
Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs
Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for manufacturers of IVDs intended to detect the presence or the…
Council adopts IVDR legacy extension and sooner mandatory use of EUDAMED
On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal for a gradual roll-out of EUDAMED as well as for…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until October 2023 on MDR and IVDR certifications and applications. As…
MDCG 2024-02 on EMDN updates
The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European…
MDCG Guidances on vigilance system for CE-marked devices
The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is…
EC Proposal to extend IVD legacy period and make EUDAMED mandatory sooner
On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy period and make EUDAMED mandatory earlier than planned. With this…
National language requirements in the EU for MDR & IVDR devices
The European Commission has released a table on the existing language requirements for manufacturers under MDR and IVDR, compiling all national language requirements required for…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…
MDR & IVDR national implementing law: Iceland
The implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR) in Iceland is carried out through the Act on Medical…
MDR: 43rd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! CESKY METROLOGICKY INSTITUT a. s. is the 43rd EU Notified Body notified under the…
Business associations’ letter on EUDAMED mandatory use
Six industry associations on medical devices and healthcare have jointly signed an open letter on the mandatory use of EUDAMED. The six associations call for…
MedTech Europe’s recommendations on May 2025 deadline for Class D IVDs
MedTech Europe published a new position paper ahead of May 2025 deadline for Class D IVDs. These are IVD devices of the highest risk-class. They…
New Team-NB position paper on medical device lifetime
Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical Devices Regulation (MDR) does not specifically provide a definition for…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two guidance documents on Annex XVI devices. Annex XVI products are…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023, the Medical Device Coordination Group updated the guidance on clinical…
First EU Reference Laboratories designated under the IVDR!
The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for vitro diagnostic devices. In July 2022, the European Commission opened…
Supply of medical devices in the EU: Survey & EU Authorities position
The European Commission and Members States are putting forward more steps to address the supply of medical devices in the EU. In this context, a…
EU and Italian authorities urge manufacturers to transition to MDR/IVDR in time
The Medical Device Coordination Group (MDCG) has issued a new revision of its notice to manufacturers and notified bodies to ensure they timely comply with MDR and…
MDR: 42nd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Scarlet NB B.V. is the 42nd EU Notified Body notified under the Regulation (EU)…
MDR: 41st Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. is the 41st EU…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
MDR and IVDR national implementation: Slovakia
The Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostics Devices Regulation 2017/746 (IVDR) have been implemented through Act 362/2011 in Slovakia. In this post, we…
MDR: 40th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body…
Switzerland: revision of MedDO for products with aesthetic functions
Similar to Annex XVI of the EU Medical Devices Regulation (MDR), since May 2021, the Swiss Medical Devices Ordinance regulates certain products that have an…
IVDR: 12th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the 12th EU Notified Body notified under the Regulation (EU) 2017/746…
What is the difference between a Clinical Study and Clinical Evaluation?
Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct and document a clinical evaluation. As per Article 61(1) MDR,…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will…
MDCG Guidance on Medical Device Software (MDSW) – Hardware combinations
The Medical Device Coordination Group (MDCG) endorsed in October 2023 a new guidance on medical devices software (MDSW) intended to work together with hardware or…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the manufacturer’s sole responsibility to select the appropriate class and rule…
Q&A on Annex XVI transitional period
In June 2023, the Official Journal of the European Union published the common specifications for the new legacy period of Annex XVI devices. The Medical…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and the Procedures for conducting clinical investigations on medical devices for human…
IVDR: 11th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics Finland Oy is the 11th EU Notified Body notified under…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices Regulation (MDR) and a mutual recognition agreement (MRA) terminated in…
Update on EUDAMED state of play
The European Commission has released new minutes of the MDCG EUDAMED working group meeting of June 29, 2023. Among other topics covered in the minutes,…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR), Poland has taken steps to establish…
New flowchart on the scope of MDR legacy period extension
On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers in deciding whether the MDR transitional period extension covers a…
Swissdamed: roll-out plan of the Swiss database on medical devices
Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD medical devices marketed in their territory – to an online…
NB Position Paper on the new MDR transition timelines
On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a position paper on the “New MDR Transition Timelines and Notified…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines…
MDR national implementation: Spain
The Spanish Agency on medical devices (AEMPS) published on March 21, 2023, its national law implementing the Medical Devices Regulation (MDR). This piece of legislation covers devices…
Updated Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has issued an updated document on their survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and the…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices. This factsheet seeks…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers in the upcoming years. We will briefly assess some of…
MDR: 39th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR! HTCert (Health Technology Certification Ltd) from Cyprus is the 39th Notified Body under the…
MDR & IVDR: New harmonised standards
On 5 July 2023, the Official Journal of the European Union published two new harmonised standards for sterilisation under the Medical Devices Regulation (MDR )…
PSUR under MDR: When it’s necessary, and what are the deadlines?
As part of the efforts to establish a more consistent and systematic review of post-market surveillance data by manufacturers under the new Medical Devices Regulation (MDR)…
Annex XVI MDR: new legacy period for devices without an intended medical purpose
Today, 21 June 2023, the Official Journal of the European Union published the final text for the new legacy period of Annex XVI devices. Annex…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…
MDR QMS compliance: Necessary elements by 2024
Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS)…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in June 2021. In this sense, as per the Customs Union between…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on significant changes regarding the transitional provision under Article 120 of…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the amendment of common specifications for products without intended medical purpose.…
Guidance on content and structure of the clinical investigation report summary
According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical investigation has to submit a report of the clinical investigation.…
Team-NB: Notified Body Confirmation Letter to prove application and signed agreement
The latest developments in the implementation of the medical devices and IVD medical devices Regulations (MDR & IVDR) brought significant changes in the transitional phase…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical devices on the Great Britain market! In Spring 2023, a…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese Market Regulations” implements the EU Regulations on medical devices and…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field of medical devices. The IMDRF aims to move forward with…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods.…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is the 38th EU Notified Body under the Regulation (EU) 2017/745…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment to the Medical Devices Regulations (MDR and IVDR). After the…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on the ongoing work of the MDCG and its subgroups. You…
The Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new transitional provisions for certain medical devices and in vitro diagnostic…
Team-NB guidance on submission of technical documentation under IVDR
Team-NB has released a new position paper on the best practice guidance for submitting technical documentation under Annexes II and III of the IVDR. To develop…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of Ireland (NSAI) is the 10th EU Notified Body notified under…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong the transitional provisions for certain medical devices and in vitro…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the…
MDCG Q&A on MDR vigilance terms and concepts
The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745.…
Updated MDCG Guidance on classification rules for IVD medical devices
In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the Guidance on classification rules for IVD medical devices. The revision…
Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)
According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow a Clinical Evaluation Consultation Procedure (CECP) when performing a conformity…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS GMBH is the 37th EU Notified Body under the Regulation…
Notified Body: templates for Lists of Standard Fees
Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed on the EU market. According to Article 50 of the…
How MDCG 2022-18 applies in Switzerland: certification gaps and notification
Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper…
MDCG Guidance on Article 5 (5) of MDR & IVDR!
The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the Medical Devices and In Vitro Diagnostics devices regulations. Thus, this…
Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!
The European Commission has adopted a new proposal to give more time to certify medical devices, which affects legacy devices under Article 120.3 of the…
IVDR: 8th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! QMD Services GmbH. is the 8th EU Notified Body notified under the Regulation (EU)…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their manual on borderline and classification for medical devices under MDR…
MDCG Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…
MDCG templates for performance study application and PMPF study notification
In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification. Documents for…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative consequences for health systems and patients, the Council found new…
New extensions to implement MDR: impact on legacy devices
The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the previous Directive. Since then, many medical devices are subject to…
MDR: 36 Notified Bodies on NANDO
The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been the latest NB notified under the Regulation (EU) 2017/745 on…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Austria. The Austrian Federal Office…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR). The first…
MDR: 35 Notified Bodies on NANDO
The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. has been the latest NB notified under…
Clinical investigations under the MDR: New Revision of MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG guidance on safety reporting in clinical investigations of medical devices…
MDCG Joint Implementation plan on IVDR
In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its joint plan on the preparedness and implementation of the In…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations…
Medical Devices in the UK: extension for CE marked devices
With Brexit, the legislation of the European Union does not apply in the United Kingdom anymore. Currently, the Medical Device Regulations 2002 (UK MDR 2002)…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination Group (MDCG) published a Q&A document on requirements relating to…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices and IVD medical devices. Since September 28, 2022, Legislative Decrees…
MDR: 34 Notified Bodies on NANDO
The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL has been the latest NB notified under the Regulation (EU)…
NB Position Papers on Technical Documentation and Transfer Agreement
In October 2022, Team-NB published several position papers. The first position paper concerns the technical documentation to provide to Notified Bodies, whereas a second one…
NB Position Papers on Cybersecurity and “Off-Label” Use
Team-NB recently published various position papers. Two of the latest publications concern Cybersecurity and “Off-Label” use of medical devices under MDR. Team-NB is the European…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class D devices and their conformity assessment in absence of EU…
NB Position Paper: What are Hybrid Audits and how to perform them?
In September 2022, Team-NB published a position paper on hybrid audits for quality management system assessments of medical devices under MDR/IVDR. Team-NB is the European…
Upcoming MDR national implementation laws: Portugal
The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of MDR 2017/745, a decree on MDR clinical investigations and IVDR performance…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.ul. Puławska 469 02-844 WarszawaCountry : Poland Phone :…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic introduced a new database: Swissdamed. Swissdamed stands for “Swiss…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and classification under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications for EU reference laboratories. The call is for EU Member…
MDCG position paper on Notified Body capacity and availability of medical devices and IVDs!
The Medical Device Coordination Group (MDCG) released a new position paper on the transition to the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) this…
MDR & IVDR national implementation: Finland
The national implementation of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Devices Regulation 2017/746 (IVDR) in Finland is regulated through the Finnish Medical Devices Act 719/2021,…
Reclassification of products without an intended medical purpose: European Commission publishes a draft act
The new draft act available on the website of the European Commission aims at regulating active products without an intended medical purpose falling under Annex…
Notified Body Designation process: MDCG guidance
The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation, re-assessment and notification under MDR & IVDR of conformity assessment…
MDR: 32 Notified Bodies on NANDO
The NANDO database newly listed 32 Notified Bodies under the MDR! BUREAU VERITAS ITALIA S.P.A.Viale Monza, 347 20126 – MILANO (MI)Country : Italy Phone :…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on the approach to the Technical Documentation assessment of multiplex IVD…
Implementation Rolling Plan July 2022 (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts and actions to take…
MDR: 31 Notified Bodies on NANDO
The NANDO database newly listed 31 Notified Bodies under the MDR! AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS has been the latest NB notified under the…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED, a new traceability system for medical devices on the EU…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the…
The European Commission lays down common specifications for Class D IVDs!
The European Commission has adopted the Commission Implementing Regulation setting out common specifications for some IVDs classified as Class D under the In Vitro Devices…
EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?
The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD sector. In line with stricter assessment procedures, the Regulation introduced…
MDR FSC: CAMD Q&A
The Competent Authorities for Medical Devices (CAMD) network issued on June 2022 a document on Questions and Answers regarding Free Sales Certificates (FSC) and Article…
MDCG & CAMD: Time to act towards MDR compliance
The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on the need for manufacturers to ensure timely compliance with MDR…
MDR: 30 Notified Bodies on NANDO
The NANDO database newly listed 30 Notified Bodies under the MDR! Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH has been the latest NB notified…
Clinical trials for medicinal products and IVDs: interface between two Regulations
The Medical Device Coordination Group (MDCG) published a Q&A document on the interfaces between two Regulations. Specifically, the Regulations involved are the Regulation on clinical trials for…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and update the Medical Device National Classification (CND). The CND groups…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully applies from May 26, 2022 CE Certificates issued under the…
IVDR: New MDCG Template on Summary of Safety and Performance
IVD manufacturers of highest risk classes shall be informed of an important template endorsed by the MDCG: 2022-9 the Summary of safety and performance Template.…
IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed…
MDR: 29 Notified Bodies on NANDO
The NANDO database newly listed 29 Notified Bodies under the MDR! TUV NORD Polska Sp. z o.o has been the latest NB notified under the…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…
European Commission: Report on delegated acts
On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report on the exercise of the power to adopt delegated acts…
Dutch MDR/IVDR implementation: Medical Devices Regulation and Medical Devices Act
The Dutch Regeling medische hulpmiddelen (cited as the Dutch Medical Devices Regulation) of 26 May 2022 is the national law implementing the Medical Devices Regulation 2017/745…
MDR Borderline guidance between medical devices and medicinal products published!
The MDCG has released new guidance on borderline cases between medical devices and medicinal products under the Medical Devices Regulation 2017/745. This guidance addresses several concepts such as…
EU and Turkey: Agreement on medical devices
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community (ECC). Already established in 1963, the Agreement creates a Customs…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…
IVDR Implementation plan March 2022: What is the status of the main priorities?
The European Commission published its update from March of the Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining the priorities and actions to…
MDR: 28 Notified Bodies on NANDO
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI has been the latest NB notified…
Summary of safety and clinical performance: MDCG Update
The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP), which is especially relevant for manufacturers of Class III and…
Austria: MDR Implementation at national level
Austria has implemented Regulation 2017/745 through the Medical Devices Act in force from 30 June 2021. The Act provides clarifications in the following areas: Competent…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and…
Lithuania: How are medical devices regulated under the MDR/IVDR?
The competent Lithuanian authority has published its implementation law to the Medical Devices Regulation 2017/745 and the In Vitro Devices Regulation 2017/746 by amending several…
Hungary: MDR implementation at national level
The Regulation (EU) 2017/745 on medical devices is implemented into Hungarian national legislation through amended Decree on the Regulation of Medical Devices 4/2009 EüM, clinical…
IVDR: Verification of class D IVDs by notified bodies
The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…
Public Consultation on Common Specifications for IVDR Class D devices
The European Commission has initiated the public consultation on the Draft Implementing Regulation (CIR) and its Annex concerning the common specifications for Class D devices…
IVDR Implementation plan February 2022: What is the status of the main priorities?
108 days ahead of the date of application, the European Commission published the updated Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining…
MDR Implementation at a national level: Romania
Romania published the Emergency Ordonnance no. 46/11.06.2021 that implements the MDR 2017/745 in the Romanian territory. The Ordonnance provides further clarifications on specific areas of…
IVDR progressive roll-out has been officially published!
The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…
Swedish MDR/IVDR implementation law: Fees, penalties and other provisions
Sweden published its implementation law of the Medical Devices Regulation 2017/745, also applying to the In Vitro Devices Regulation 2017/746. This Act establishes several provisions…
Public consultation on MDR Annex XVI Implementing Regulation open!
The European Commission has opened the public consultation on the draft Commission Implementing Regulation (CIR) and its Annex concerning the common specifications for products listed…
Notice to third country manufacturers of SARS-CoV-2 IVDs
The competent national authorities have identified several common issues while implementing market surveillance activities (presented below) to ensure the compliance of IVDs with the applicable…
MDR: 27 Notified Bodies on NANDO
The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been the latest NB notified under the Regulation (EU) 2017/745 on…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products,…
MDR Implementation in Estonia
The national law for medical devices in Estonia is the Medical Devices Act–Riigi Teataja, which was amended on 01.04.2023 to comply with the MDR 2017/745.…
MDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices,…
MDR: 26 Notified Bodies on NANDO & Swiss economic operator’s requirements updated!
The NANDO database newly lists 26 Notified Bodies under the MDR! TÜV NORD CERT GmbH has been the latest NB notified under the Regulation (EU)…
Poland: works on the MDR implementation at the national level
Since 26 May 2021, the Regulation (EU) 2017/745 on medical devices directly applies in Poland as the implementing law is yet to be introduced. Previously…
The European Parliament and the Council of the EU adopt IVDR progressive roll-out!
The two co-legislators of the European Union: the European Parliament and the Council of the EU have commonly agreed to delay the date of application…
New Regulation on electronic instructions for use of medical devices!
From the next 4th of January 2022 enters into force a new Commission Implementing Regulation (CID) introducing electronic instructions of use (IFUs) for medical devices.…
MDR: How are medical devices regulated in Denmark?
The Danish Ordinance on medical devices and products without medical purpose (BEK nr 837 af 20/06/2023) is the national implementation law applicable as of 29th…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details on the implementation of Articles 13 and 14 and other…
New MDCG guideline & template: Modification to Clinical investigations
The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under the Medical Devices Regulation 2017/745 (MDR). In this sense, it…
EXPAMED publishes its new Opinion on Performance Evaluation Consultation procedure (PECP)
The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been the latest NB notified under the Regulation (EU) 2017/745 on…
Norwegian legislation on medical devices: MDR implementation
The Regulation (EU) 2017/745 on medical devices (MDR) was implemented into national law of Norway through two legislative acts Regulation 9 of May 2021 no…
EUDAMED: NB & Certificates – Useful documents
EUDAMED or the European database on medical devices has been designed to support the implementation of the EU Medical Devices Regulations. EUDAMED is composed of…
IVDR Implementation plan: What is the status of the main priorities?
The MDCG has released the updated Joint implementation and preparedness Plan for IVDR noting significant progress has been achieved. For example, The necessary implementing acts…
Timeline for MDCG guidance documents updated
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…
MDCG Q&A on repackaging/relabelling and MDR legacy requirements
The Medical Device Coordination Group has issued two very useful guidances for importers and distributors on repackaging and relabelling activities under MDR and IVDR as…
MDR: 24 Notified Bodies on NANDO
The NANDO database newly lists 24 Notified Bodies under the MDR! CERTIQUALITY S.r.l. has been the latest NB notified under the Regulation (EU) 2017/745 on medical…
The European Commission is proposing to give more time to certain IVDs to reach IVDR compliance!
The European Commission (EC) has presented a proposal to amend the timeline of the future In Vitro Devices Regulation 2017/746 for certain IVDs. More specifically,…
New MDCG Guidance on classification of medical devices under MDR
The MDCG has published a very important Guidance on classification of medical devices under the MDR – Regulation (EU) 2017/745: MDCG 2021-24. The document mainly analyzes the classification rules of Annex VIII of the…
More EUDAMED modules now available
The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This allows Economic Operators and Notified Bodies to start entering data…
New labeling obligations under the MDR
Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out additional requirements manufacturers need to adhere to for device labeling.…
German national requirements for medical devices
The Medical Devices EU Adaptation Act (MPEUAnpG) and the Medical Devices Implementation Act (MPDG) The new Regulation (EU) 2017/745 (MDR) entails adaptation acts at a…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
HERA: New European Health Emergency preparedness and Response Authority
The COVID-19 pandemic highlighted the need of a centralized management system in the health sector to ensure that the EU and the Member States are ready…
IVDs Expert Panel is operational!
Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of the In Vitro Diagnostic Medical Devices Regulation- 2017/746. The expert…
MDR: 23 Notified Bodies on NANDO
The NANDO database newly lists 23 Notified Bodies under the MDR! TUV Rheinland Italia SRL has been the latest NB notified under the Regulation (EU)…
Reprocessing of single-use devices, clinical investigations and offences under MDR: Ireland
The text of the Medical Device Regulation (MDR) became directly applicable on the European Union market as of May 26, 2021. Nevertheless, the EU Member…
MDCG Guidance for NBs, importers, and distributors: QMS certification for relabelling & repackaging
Under Article 16(4) of the MDR and IVDR, a distributor or an importer that relabels (translates) or repackages a device shall get their Quality Management…
IVDR: 6th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! GMED SAS is the 6th EU Notified Body notified under the Regulation…
Class D IVDR: Clarification on “first certification for that type of device” by MDCG
The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on…
EU MDR v. CH MedDO: How are medical devices regulated on the Swiss market?
Due to the absence of the Mutual Recognition Agreement between the EU and Switzerland on the day the EU MDR became fully applicable on the…
COVID-19 IVDs: MDCG Guidance on performance evaluation
The MDCG has endorsed a 2021-21 Guidance on performance evaluation of SARS–CoV–2 in vitro diagnostic medical devices for the conformity assessment under IVDD and IVDR.…
22 MDR Notified Bodies on NANDO and MDCG instructions on Clinical Investigation ID
The NANDO database newly lists 22 Notified Bodies under the MDR! EUROFINS PRODUCT TESTING ITALY S.R.L. has been the latest NB notified under the Regulation (EU)…
First harmonised standards under MDR& IVDR are now available!
The European Commission has published in the Official Journal of the European Union (OJEU) the Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system…
MDR: 21 Notified Bodies on NANDO!
The NANDO database newly lists 21 Notified Bodies under the MDR! KIWA CERMET ITALIA S.P.A. has been the latest NB notified under the Regulation (EU)…
MDCG Explanatory note on IVDR codes
The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro diagnostic medical devices, which is done by the manufacturer when…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article…
Expert panels: First opinion on Class III implantable device released
What is the role of Expert panels? According to articles 106 and 48(6) of the Medical Device Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…
MDCG Q&A on EUDAMED Actor registration for legacy & custom-made device manufacturers, SPPP
The MDCG has released a Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article 28. Some terms,…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! DEKRA Certification B.V. is the 5th EU Notified Body notified under the…
Manufacturers of implantable medical devices: new MDCG guidance on implant card!
The MDCG has released a very important guidance on the ”device type” to be shown on the implant card of an implantable medical device as…
IVDR Joint Implementation Plan: Priority actions
Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination Group (MDCG) has released a Joint Implementation and preparedness plan for Regulation (EU) 2017/746…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down questions and answers on the EMDN (European Medical Device Nomenclature)…
3 days under the MDR & new MDCG Position Paper on UDI
26 of May 2021 was probably the most important day of 2021 for the medical device community in terms of regulatory changes. The Medical Device…
Clinical investigation application/notification under MDR: MDCG provides important templates
The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the signed Mutual Recognition Agreement (MRA) between Switzerland and the European…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in implementing the UDI-related requirements of the MDR and IVDR and…
Standardisation request for the EU MDR & IVDR: update
The European Commission has informed that the Standardisation request from 14.4.2021 in support of Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] has been accepted…
EMDN is online!
The European Commission has released and opened for consultation the first (English) version of the European Medical Device Nomenclature (EMDN). This is an important step…
Overview of published documents Jan-April 2021
To improve MDlaw experience and to keep you informed of all the relevant publications of the first four months of 2021, we present the below…
Update to MDCG UDI Guidance & Minutes from the recent MDCG meetings released!
Guidance on BASIC UDI-DI and changes to UDI-DI The new revision of the MDCG guidance on the Unique Device Identification (UDI) system for medical devices…
Clinical investigations under MDR: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying certain aspects of clinical investigation of medical devices within the…
MDCG guidance on standardisation for medical devices
The MDCG document pursues to provide guidance on several features related to standards in the medical devices industry supporting the requirements set down in the…
Standardisation request for the EU MDR & IVDR
The European Commission has notified today CEN and Cenelec of the Standardisation request in the Implementing Decision C(2021) 2406, which will serve as the basis…
IVDR Certification of Class D devices, Implementation Plan and MDR NB
The MDCG released an important Q&A for manufacturers of Class D devices and their certification during the transition period – until 26 May 2022 or…
Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the European Union, the Swiss Federal Office of Public…
Language requirements & sanctions under the MDR: Belgium
The text of the Medical Device Regulation (MDR) will become directly applicable on the Union market on May 26, 2021. Nevertheless, the EU Member States…
State of the art of COVID-19 rapid antibody tests and state of the art & IVDR
The IVDD requires from the manufacturers to design and manufacture devices in such a way that they are suitable for the intended purpose, taking into…
MDCG Guidance on MDR custom-made devices
The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made devices, adaptable medical devices and patient-matched medical devices as regulated…
EUDAMED: State-of-play
Despite projections that it will be possible to perform device and Certificate registration directly to EUDAMED from May 2021 – aligning with the MDR date…
Overview of published documents – February 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library of…
MDCG Guidance on practices and solutions until EUDAMED is fully functional
MDCG issued its first 2021 guidance that clarifies to Member States and other parties on the application of certain MDR provisions during the absence of EUDAMED.…
MDR: 19th Notified Body on NANDO!
The NANDO database newly lists 19 Notified Bodies under the MDR! ISTITUTO SUPERIORE DI SANITA has been notified under the Regulation (EU) 2017/745 on medical…
EUDAMED Management of Legacy Devices
The European Commission recently published Management of Legacy Devices (version 1.1, issued on 08.02.2021.), a document that further clarifies the registration of Legacy devices on…
Overview of published documents – January 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library of…
Dedicated webpages on MDR & IVDR (European Commission)
The European Commission has released dedicated webpages, which are divided in several areas, where you can find relevant Factsheets, Implementation timeline and other helpful documents:…
New MDR NB & UK MHRA Guidance & QMS Remote Audits
SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU) 2017/745 on medical devices and displayed on the NANDO website…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the medical device community. Today, we highlight the removal of UK-based…
Update: EC Implementing acts and MDCG Guidance in 2020 & 2021
With the release of the latest Implementation Rolling Plan, we present below future implementing acts/actions by the European Commission and respective dates of publication: Q1…
UDI assignment for Spectacle lenses & Ready readers
The MDR is introducing the obligation of manufactures to assign the Unique Device Identification (UDI) on their devices, in order to improve the identification of…
MDR: 18th Notified Body on NANDO!
The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the 18th Notified Body (17th within the Union) notified under the…
COVID-19 & NB audits: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19…
Actor registration to EUDAMED is now possible!
Actor module of EUDAMED is active as of December 1, 2020! It is now possible to register yourself as an economic operator and obtain the…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! TÜV Rheinland LGA Products GmbH is the 5th Notified Body (4th within…
EUDAMED Actor Registration: European Commission Q&A
Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on this Platform. The European Commission now released a very useful…
IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released!
The MDCG published a very important document for all IVD manufacturers, as well as for notified bodies and health institutions, which shall provide guidance on…
Building a European Health Union: medical device shortage addressed
The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness and response for Europe and three Proposals for a Regulation…
Designation process of MDR/IVDR Notified Bodies – update
The EU Commission has recently released a graphic that numerically reflects how many Notified Bodies are currently undergoing the different enabling steps to eventually be…
EUDAMED – Actor registration: new Commission webpage with important guides & templates
The European Commission has launched a new webpage dedicated to the Actor registration module of EUDAMED, where it confirmed that the actor registration module will…
What is a Regulatory Strategy?
‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory framework on medical devices introduced by the upcoming Regulation (EU)…
Upcoming MDCG WG meetings – October 2020
The MDCG Working Groups will be discussing interesting points in the upcoming October meetings: EMDN Overview of EMDN development [for more information on EMDN, have…
MDR/IVDR Implementing acts in Q4 2020
As per the Commission MDR/IVDR Implementation Rolling Plan, we can expect the following Implementing acts in the last quarter of 2020: Common specifications for products…
MDR:17th NB Designation
Since this morning, the NANDO database is richer for a new certification body. The Notified Body 3EC International a.s. is the 17th Notified Body notified…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how it shall regulate medical devices after 1 January 2021. The…
Common specifications for reprocessing of single-use devices published
The MDR (Regulation (EU) 2017/745) allows reprocessing of single-use devices only where it is permitted by national law. In fact, when reprocessed and used within…
New MDCG Position Paper on EUDAMED actor registration module and SRN released
On 18.08.2020, the MDCG published a Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN). Following…
Highlights of the week
Please be informed that our Library of Documents is richer for the below documents, published in the past week: Update to the European Commission FAQ…
MDR: 16th NB Designation
Over the weekend, the NANDO database has been updated with a new name. The German Notified Body DQS is the 16th Notified Body accredited under…
New MDCG Guidance for Notified Bodies
The MDCG issued a new Guidance for notified bodies on the use of MDSAP (Medical Device Single Audit Program) audit reports in the context of…
MDR & EUDAMED: Which information will be available to the public?
The European Commission services recently issued a Fact sheet on MDR requirements for Transparency and Public Information. The document first emphasizes the importance of transparency…
Highlights of the week (CEAR)
Clinical evaluation assessment report template released by the MDCG Clinical evaluation assessment report (CEAR) will document the conclusions of the Notified Body assessment of the…
MDR/IVDR Standardisation Request
As we can read in the recently published minutes from the 19th June meeting of the MDCG sub-group on Standards, CEN and CENELEC rejected the…
Update to the NB designation process
The European Commission released an updated overview of the Notified Body accreditation process under the EU MDR and IVDR. As of 13 of July 2020,…
New MDR NB designation
The French Notified Body GMED is newly listed on the NANDO website, and is the 15th Notified Body accredited under the Regulation (EU) 2017/745 on…
UDI for systems and procedure packs: Example added to MDCG Guidance
The MDCG updated its 2018-3 Guidance on UDI for systems and procedure packs, and added the below, highlighted example to the exemption under Section 3.2…
Highlights of the week
We are happy to announce our collaboration with Team-PRRC, who recently joined Our Network. Our Library of documents was updated with: Guidance on regulatory requirements…
How many MDR/IVDR Notified Bodies we have by June 2020?
Approaching second half of 2020, NANDO database currently lists 14 Notified Bodies accredited under the MDR with updates to listing of BSI Group The Netherlands…
MDCG: Consultation under MDR Article 52(9) for (AI)MDD certified devices
The MDCG issued a Guidance on the conformity assessment procedure for special category of devices as per the Article 52 of the MDR: ‘‘for devices…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
COVID-19: MDCG on NB designation renewals + surveillance
Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning to layout common criteria for the renewal of Notified Body…
Commission Implementing Regulation on NB designations + Commission Communication on Union-wide derogations
Our Library of Documents is richer for two more documents addressing the COVID-19 pandemic: Commission Implementing Regulation: renewal of designations and the surveillance and monitoring…
Manufacturer Incident Report + MDR consolidated version
Please be aware that there were new/updated forms published on the Commission website with regard to incident reporting: Manufacturer incident report 2020 (Form) Manufacturer incident…
New NB under the MDR!
This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under the MDR. Intertek Medical Notified Body AB Torshamnsgatan 43, Box…
Clinical investigations under the MDR: MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) has published a guidance document on Safety reporting in the context of clinical investigations. According to Article 80(2) and…
Planning of MDCG guidance documents updated
You will find below the updated document on the ongoing work of the MDCG and its subgroups. Majority of guidance documents has the deadline foreseen…
New MDR NB designation + MDCG addressing COVID-19 outbreak
NANDO is richer for a new MDR accredited Notified Body, which brings us to 13 certification bodies designated under the new Regulation: MDC MEDICAL DEVICE…
MDCG: PMCF Templates, Equivalence, Clinical evidence for legacy devices
The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template for a Plan and Report and guide on equivalence and…
MDR delay is official – new Regulation published in the Official Journal!
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the…
MDR delay approved also by the Council!
The Council of the EU agreed to the position of the European Parliament in a written procedure and adopted the REGULATION OF THE EUROPEAN PARLIAMENT…
European Parliament approves to move forward with MDR delay Proposal
In the final vote announced today at 16h, the European Parliament approved to move forward with the Proposal to delay the MDR (Regulation 2017/745 on…
Council gives green light to launch negotiations on MDR delay + MDCG Guidance on NB audits during COVID-19
The Council of the European Union agreed today to a Mandate for launch of negotiations with the European Parliament to delay MDR under urgent procedure.…
Pre-market clinical evaluation consultation procedure: Update to MDCG guidance
The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from…
EC Proposal to delay MDR: which provisions are affected?
The European Commission proposal for the MDR delay is now officially published and accessible through: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589 Proposal for a Regulation of the European Parliament and…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6 months. Next meeting of the MDCG is only planned for…
MDR delayed for 12 months due to COVID-19?
The European Commission is proposing to delay the MDR for 12 months to fight the current COVID-19 outbreak! Watch a short video following today’s European…
We have the 12th NB under the MDR!
Over the weekend, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745:…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the Notified Bodies under the MDR and IVDR. As it is…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the past day! 2020-01 Guidance on Clinical Evaluation (MDR) / Performance…
Guidance on significant change for legacy devices (MDR)
All manufacturers making use of the grace period as per the Article 120 (3) of the MDR – with a CE Certificate issued under the…
MDCG Joint Implementation/preparedness plan on MDR
The MDCG just publicly announced that the Actor registration will be available in EUDAMED by May 2020! This means that manufacturers will be for ex.…
MDR: Consolidated text
We are happy to share with you that the consolidated version of the MDR – Regulation (EU) 2017/745 was published on EUR-lex. The new text…
MDR implementation update and timeline
Update on the process CAMD Roadmap actions on the MDR Implementation 51 actions: work in progress and will be published soon 49 actions: leader has…
MDR: New NB designation
The European Commission announced the 11th Notified Body designated under the Regulation (EU) 2017/745: National Standards Authority of Ireland (NSAI) 1 Swift Square, Northwood, Santry…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745: DNV…
Risk Management
In view of the recently published ISO 14791:2019, our experts updated the already published MDlaw guidance document/template to assist you drawing a detailed Risk…
Annex XVI MDCG sub-group: Become an observer
Under the EU MDR and IVDR, the MDCG (Medical Device Coordination Group) provides advice and assists the European Commission and the Member States in ensuring…
State-of-play of NB designations
The European Commission (EC) published a document on the state-of-play of designation process of Notified Bodies under the MDR and IVDR: 44 applications received for…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health and Food Safety (move from DG GROW to DG SANTE)…
Croatian Presidency of the EU
Croatia has started presiding the Council of the European Union on the 1st of January 2020, and will remain in this role until the 30th…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and has the purpose to help medical device manufacturers and other…
MEDCERT designated under the MDR (9th NB)
With the below German Notified Body, designated for the assessment of devices under the MDR – (EU) 2017/745, we reached the number of 9, despite…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for the assessment of devices under the In Vitro Diagnostic Medical…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing development of guidance documents within MDCG Subgroups. We shall still…
MDCG Guidance for Class I manufacturers!
The MDCG published today well awaited Guidance for Class I manufacturers! The MDCG enlists tasks to be carried out by a Class I manufacturer to…
8th NB designated under MDR
NANDO database is richer for another Notified Body accreditation under the Medical Device Regulation – (EU) 2017/745. Dutch Notified Body DEKRA is the 8th NB…
MDCG Guidance on MDR/IVDR device sampling + MDR Codes
The MDCG published two important guidance documents this afternoon. Firstly, an Explanatory note on MDR Codes, i.e. MDA/MDN, MDS, MDT was published. These Codes are…
UDI issuing entities on Basic-UDI and UDI formats
The four accredited UDI issuing entities (which were designated by the Commission Implementing Decision of 7 June 2019) released further specifications on Basic UDI-DI and…
MDR Corrigendum: Derogation for certain up-classified devices
The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as a new version of the Corrigendum was published. However, the…
6th and 7th MDR Notified Body designated
The European Commission announced two more Notified Body designations under the Medical Device Regulation in the last two days: DARE!! Services B.V. Vijzelmolenlaan 7 NL-3447…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ” The Commission concluded that it will only be possible to…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined (TBD), however here below we present the documents that shall…
EMA Q&A Document on implementation of MDR and IVDR update released.
Questions and Answers document updated version has been released on 21.10.2019 by the European Medicines Agency (EMA). Notified bodies should seek authorisation to the EMA…
Updated version of MDCG Q&A Document released in June 2019
The MDCG has updated the useful Questions & Answers document focusing on the Notified Bodies’ requirements under MDR and IVDR. It widens the scope of…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR. The MDCG…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a Notified Body under MDR and IVDR, used by the Designating…
DEKRA is the first NB accredited for the IVDR
This morning, the European Commission updated the NANDO database, by adding the first Notified Body that was designated under the Regulation (EU) 2017/746 on in…
MDCG: MDR Transitional regime
The MDCG published on Friday a guidance document, where it further clarified Article 120 (2), (3) of the MDR – Transitional provisions. These provisions allow…
Summary of safety and clinical performance: Content, Template by MDCG
The MDCG published a guidance document, specifically targeted at manufacturers and Notified Bodies, on the summary of safety and clinical performance (SSCP). The MDR requires…
5th Notified Body under the MDR!
The European Commission announced another designation of a Notified Body under the Regulation (EU) 2017/745 on medical devices. This is the 5th Notified Body accredited…
Commission Implementing Decision under MDR: Expert panels
On 11 September 2019, the Official Journal of the European Union was updated with a new Implementing Decision adopted by the European Commission. The Decision…
Guidelines on phthalates in medical devices finalised
In 2019, the independent scientific committee SCHEER published the Guidelines on the benefit-risk assessment of the presence in certain medical devices of phthalates. The guidance…
First MDR Conformity Certificate issued
We are happy to inform you that the Notified Body BSI UK certified the first device – classified as a IIa device – under Rule…
Another Notified Body designated under the MDR!
The European Commission published another designation of a NB under the Regulation (EU) 2017/745 on medical devices. This is the 4th Notified Body designated under…
3rd Notified Body under the MDR!
We are happy to announce that the European Commission updated the NANDO website with a new name: DEKRA Certification GmbH. DEKRA, the German Notified Body,…
Recent updates to MDR e-book & MDR Deadlines
Following the clarifications from the MDCG, our MDR dedicated e-books were updated to reflect the recent updates and prepare you adequately for the requirements of…
First Guideline on cybersecurity of medical devices incorporating software (MDIS)
Becoming increasingly important also for the med tech sector in view of the technical advancement, cybersecurity aims at incorporating measures, both technical and organisational, that…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing of single-use medical devices (rules and common specifications) until 20th…
Implant Card under the MDR {MDCG}
The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC) disciplined by MDR Article 18 and on information to be…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC. The main clarifications focused on qualification of the…
Draft EMA Guideline + MDCG Guidance to be endorsed
EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination products that will close on the 31st of August 2019.…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
MDCG on registration of devices in EUDAMED (timelines)
In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article 123(3)(d) and 123(3)(e) of the MDR. These provisions foresee certain…
MDCG on registration of ”legacy” devices
The second document related to EUDAMED was published today on the European Commission website. The MDCG discussed registration of a ”legacy” device, i.e. device with…
New MDlaw Checklist: Crucial tool to show compliance with Annex I MDR
New GSPR Checklist, now available in our MDlaw e-shop was carefully prepared by our experts to help you comply with the General Safety and Performance…
MDCG: When pre-market consultation of expert panel is not required
MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b that was so far subject to different interpretations. Second paragraph…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent study organized by the Team-NB concerning the 2018 and wished…
EMA Q&A on Article 117 of MDR: Medicines with medical device component
Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article 117 of the Medical Devices Regulation (MDR) that requires intervention…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…
Combination products: MDCG provides guidance on UDI-related obligations
The MDCG endorsed a new guidance on the UDI-related obligations when it comes to medical devices that administer/incorporate medicinal substances, human tissues and cells as…
MDCG Position on Content of the certificates, voluntary certificate transfers just published!
The MDCG endorsed a Position document – Guidance on content of the certificates, voluntary certificate transfers where it discussed: Content of the certificate under MDR…
NBs on Classification Rule 8 of the MDR
NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR…
MDCG guiding principles for issuing entities: Basic UDI-DI
MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities rules that the Basic UDI-DI requirements on format should be…
NEW eBOOKS: How will the new Regulations (MDR/IVDR) impact you?
We are happy to announce the below two new publications that were added to our MDlaw e-shop! MDR eBOOK IVDR eBOOK In approximately 200 pages,…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database! The first NB…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently: From 20 Team-NB notified bodies…
EC public reply to PIP fraud Petition
The European Commission (EC) published a public letter to the PIP Implants World Victims Association and rejected the petition to claim the financial compensation at…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how a ”no deal” Brexit will affect the regulatory framework of…
TEAM-NB Survey on NB Designation process
The Team-NB performed a new survey in December and collected the data on the designation process of Notified Bodies under the MDR. On the date…
NB express concerns on MDR application date
Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 – 1 year after the designation process of Notified Bodies under…
New judgment of the CJEU: Access to Documents on NB
On the 5th of December 2018, the General Court (the Court) delivered a judgment (currently only in French and Italian language) on access to documents…
European Commission publishes NEW Information sheets
The European Commission has published today 9 Factsheets related to the MDR and IVDR. The documents present main changes, new requirements, transition timeline and frequent…
Update on received NB Applications by the EC
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs) under the MDR/IVDR at the date of 9 October 2018.…
Brexit and MDR: UK publishes two notices
Notice of 23 August: MDR, CE marking in “no-deal” scenario (after 29 March 2019) For a time-limited period, UK would continue to recognise the CE Mark…
European Commission has received 28 applications from NBs
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs) under the MDR/IVDR at the date of 30 June 2018:…
Team-NB: 65% of Members submitted applications to be designated under the MDR
The Team-NB conducted a second survey this year to establish the number of Notified Bodies that applied for the designation under the MDR. So far, 65% of…
Joint Action on Market Surveillance of MD
The UK Medicines and Healthcare products Regulatory Agency and Chafea, executive agency of the European Commission have signed a Grant Agreement in order to reinforce market surveillance of…
Only 5 NB applied under MDR by mid-February
The European Commission received only five preliminary assessment reports from the “designating authorities” by February 12, 2018. As previously discussed on this blog, the submission of the application…
Survey by TEAM-NB on applications of Notified Bodies under MDR
As stated in the survey performed by Team-NB*, already 80% of the Team-NB members submitted their application to be designated against the MDR by mid February. Half…
Implementing MDR: Focus on transition period by COCIR and CAMD
Today, COCIR* issued a Position paper on the implementation of the future Regulation on Medical Devices (MDR). The document addresses the transitional period, while putting…
EU Court decides: Software as MD
On 7 December 2017, the Court of Justice of the European Union rendered a judgment in the case of Syndicat national de l’industrie des technologies médicales…
1st Commission Implementing Regulation published!
After the closing of public consultations, the first Commission Implementing Regulation under MDR and IVDR was published in the Official Journal of the EU. As…
New MDR Implementation Tools available in our E-shop !
The below two documents will help manufacturers better understand the MDR timeline, how to comply with the new legal requirements and provide some useful recommendations.…
The Commission publishes NEW list of harmonised standards
The European Commission published an updated list of CEN/ Cenelec harmonised standards in the framework of the implementation of the IVD Directive 98/79/EC. The harmonised standards published for the…
Applications to be designated as NB under MDR/IVDR open from 26 November
6 months after entering into force of the new legislation, the European Commission issued a notice informing of the possibility to submit the application to…
Brexit contingency plan: No-deal scenario
The UK Secretary of State for Health and Social Care sent a letter to all suppliers of medical devices outlining the contingency planning in case…
MDCG Working Groups: Tasks, Membership, Meetings
The Terms of reference of the following MDCG Working Groups were recently published: MDCG Working Group 1: Notified Bodies Oversight (NBO) MDCG Working Group 2:…