In June 2023, the Official Journal of the European Union published the common specifications for…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and…
IVDR: 11th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI…
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…
Update on EUDAMED state of play
The European Commission has released new minutes of the MDCG EUDAMED working group meeting of…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic…
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…
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…
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…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are…
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…
MDR national implementation: Spain
The Spanish Agency on medical devices (AEMPS) published on March 21, 2023, its national law implementing the…
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…
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…
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…
MDR: 39th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR! HTCert (Health Technology Certification…
MDR & IVDR: New harmonised standards
On 5 July 2023, the Official Journal of the European Union published two new harmonised…
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…
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…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations…
MDR QMS compliance: Necessary elements by 2024
Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on…
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…
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…
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…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of…
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),…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is…
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…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics…
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 Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new…
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…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION…
MDCG Q&A on MDR vigilance terms and concepts
The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts…
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…
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…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS…
Notified Body: templates for Lists of Standard Fees
Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed…
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),…
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…
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…
IVDR: 8th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! QMD Services GmbH. is…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their…
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…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be…
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…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative…
New extensions to implement MDR: impact on legacy devices
The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the…
MDR: 36 Notified Bodies on NANDO
The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent.…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex…
MDR: 35 Notified Bodies on NANDO
The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A…
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…
MDCG Joint Implementation plan on IVDR
In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations…
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…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices…
MDR: 34 Notified Bodies on NANDO
The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL…
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…
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”…
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…
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…
Upcoming MDR national implementation laws: Portugal
The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose,…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications…
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…
MDR & IVDR national implementation: Finland
The national implementation of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Devices Regulation 2017/746 (IVDR)…
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…
Notified Body Designation process: MDCG guidance
The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation,…
MDR: 32 Notified Bodies on NANDO
The NANDO database newly listed 32 Notified Bodies under the MDR! BUREAU VERITAS ITALIA S.P.A.Viale…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on…
Implementation Rolling Plan July 2022 (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
MDR: 31 Notified Bodies on NANDO
The NANDO database newly listed 31 Notified Bodies under the MDR! AGENCIA ESPAÑOLA DE MEDICAMENTOS…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED,…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database…
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…
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…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD…
MDR FSC: CAMD Q&A
The Competent Authorities for Medical Devices (CAMD) network issued on June 2022 a document on…
MDCG & CAMD: Time to act towards MDR compliance
The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on…
MDR: 30 Notified Bodies on NANDO
The NANDO database newly listed 30 Notified Bodies under the MDR! Berlin Cert Prüf- und…
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.…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully…
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…
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…
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…
MDR: 29 Notified Bodies on NANDO
The NANDO database newly listed 29 Notified Bodies under the MDR! TUV NORD Polska Sp.…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The…
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…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the…
European Commission: Report on delegated acts
On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report…
Dutch MDR/IVDR implementation: Medical Devices Regulation and Medical Devices Act
The Dutch Regulation of the Minister for Medical Care (cited as the Dutch Medical Devices…
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…
EU and Turkey: Agreement on medical devices
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation…
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…
MDR: 28 Notified Bodies on NANDO
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY…
Summary of safety and clinical performance: MDCG Update
The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP),…
Austria: MDR Implementation at national level
Austria has implemented Regulation 2017/745 through the Medical Devices Act in force from 30 June…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity…
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…
Hungary: MDR implementation at national level
The Regulation (EU) 2017/745 on medical devices is implemented into Hungarian national legislation through amended…
IVDR: Verification of class D IVDs by notified bodies
The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to…
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…
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…
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…
IVDR progressive roll-out has been officially published!
The Official Journal of the European Union (OJEU) has officially listed the amendment of the…
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…
Public consultation on MDR Annex XVI Implementing Regulation open!
The European Commission has opened the public consultation on the draft Commission Implementing Regulation (CIR)…
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…
MDR: 27 Notified Bodies on NANDO
The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195…
MDR Implementation in Estonia
The national law for medical devices in Estonia is the Medical Devices Act RT I…
MDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182…
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…
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…
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…
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…
MDR: How are medical devices regulated in Denmark?
The Danish Ordinance on medical devices and products without medical purpose (BEK nr 957 af…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details…
New MDCG guideline & template: Modification to Clinical investigations
The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under…
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…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been…
Norwegian legislation on medical devices: MDR implementation
The Regulation (EU) 2017/745 on medical devices (MDR) was implemented into national law of Norway…
EUDAMED: NB & Certificates – Useful documents
EUDAMED or the European database on medical devices has been designed to support the implementation…
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…
Timeline for MDCG guidance documents updated
The European Commission has released the updated document on the ongoing work of the MDCG…
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…
MDR: 24 Notified Bodies on NANDO
The NANDO database newly lists 24 Notified Bodies under the MDR! CERTIQUALITY S.r.l. has been the…
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…
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…
More EUDAMED modules now available
The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This…
New labeling obligations under the MDR
Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out…
German national requirements for medical devices
The Medical Devices EU Adaptation Act (MPEUAnpG) and the Medical Devices Implementation Act (MPDG) The…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
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…
IVDs Expert Panel is operational!
Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of…
MDR: 23 Notified Bodies on NANDO
The NANDO database newly lists 23 Notified Bodies under the MDR! TUV Rheinland Italia SRL…
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…
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…
IVDR: 6th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! GMED SAS…
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…
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…
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…
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…
First harmonised standards under MDR& IVDR are now available!
The European Commission has published in the Official Journal of the European Union (OJEU) the…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR /…
MDR: 21 Notified Bodies on NANDO!
The NANDO database newly lists 21 Notified Bodies under the MDR! KIWA CERMET ITALIA S.P.A.…
MDCG Explanatory note on IVDR codes
The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration…
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…
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…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! DEKRA Certification…
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…
IVDR Joint Implementation Plan: Priority actions
Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down…
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…
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…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in…
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…
EMDN is online!
The European Commission has released and opened for consultation the first (English) version of the…
Overview of published documents Jan-April 2021
To improve MDlaw experience and to keep you informed of all the relevant publications of…
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…
Clinical investigations under MDR: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying…
MDCG guidance on standardisation for medical devices
The MDCG document pursues to provide guidance on several features related to standards in the…
Standardisation request for the EU MDR & IVDR
The European Commission has notified today CEN and Cenelec of the Standardisation request in the…
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…
Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland…
Language requirements & sanctions under the MDR: Belgium
The text of the Medical Device Regulation (MDR) will become directly applicable on the Union…
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…
MDCG Guidance on MDR custom-made devices
The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made…
EUDAMED: State-of-play
Despite projections that it will be possible to perform device and Certificate registration directly to…
Overview of published documents – February 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the…
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…
MDR: 19th Notified Body on NANDO!
The NANDO database newly lists 19 Notified Bodies under the MDR! ISTITUTO SUPERIORE DI SANITA…
EUDAMED Management of Legacy Devices
The European Commission recently published Management of Legacy Devices (version 1.1, issued on 08.02.2021.), a…
Overview of published documents – January 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the…
Dedicated webpages on MDR & IVDR (European Commission)
The European Commission has released dedicated webpages, which are divided in several areas, where you…
New MDR NB & UK MHRA Guidance & QMS Remote Audits
SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU)…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the…
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…
UDI assignment for Spectacle lenses & Ready readers
The MDR is introducing the obligation of manufactures to assign the Unique Device Identification (UDI)…
MDR: 18th Notified Body on NANDO!
The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the…
COVID-19 & NB audits: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary…
Actor registration to EUDAMED is now possible!
Actor module of EUDAMED is active as of December 1, 2020! It is now possible…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! TÜV Rheinland…
EUDAMED Actor Registration: European Commission Q&A
Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on…
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…
Building a European Health Union: medical device shortage addressed
The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness…
Designation process of MDR/IVDR Notified Bodies – update
The EU Commission has recently released a graphic that numerically reflects how many Notified Bodies…
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…
What is a Regulatory Strategy?
‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory…
Upcoming MDCG WG meetings – October 2020
The MDCG Working Groups will be discussing interesting points in the upcoming October meetings: EMDN…
MDR/IVDR Implementing acts in Q4 2020
As per the Commission MDR/IVDR Implementation Rolling Plan, we can expect the following Implementing acts…
MDR:17th NB Designation
Since this morning, the NANDO database is richer for a new certification body. The Notified…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how…
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…
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…
Highlights of the week
Please be informed that our Library of Documents is richer for the below documents, published…
MDR: 16th NB Designation
Over the weekend, the NANDO database has been updated with a new name. The German…
New MDCG Guidance for Notified Bodies
The MDCG issued a new Guidance for notified bodies on the use of MDSAP (Medical…
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…
Highlights of the week (CEAR)
Clinical evaluation assessment report template released by the MDCG Clinical evaluation assessment report (CEAR) will…
MDR/IVDR Standardisation Request
As we can read in the recently published minutes from the 19th June meeting of…
Update to the NB designation process
The European Commission released an updated overview of the Notified Body accreditation process under the…
New MDR NB designation
The French Notified Body GMED is newly listed on the NANDO website, and is the…
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…
Highlights of the week
We are happy to announce our collaboration with Team-PRRC, who recently joined Our Network. Our…
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…
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…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
COVID-19: MDCG on NB designation renewals + surveillance
Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning…
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…
Manufacturer Incident Report + MDR consolidated version
Please be aware that there were new/updated forms published on the Commission website with regard…
New NB under the MDR!
This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under…
Clinical investigations under the MDR: MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) has published a guidance document on Safety reporting in…
Planning of MDCG guidance documents updated
You will find below the updated document on the ongoing work of the MDCG and…
New MDR NB designation + MDCG addressing COVID-19 outbreak
NANDO is richer for a new MDR accredited Notified Body, which brings us to 13…
MDCG: PMCF Templates, Equivalence, Clinical evidence for legacy devices
The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template…
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…
MDR delay approved also by the Council!
The Council of the EU agreed to the position of the European Parliament in a…
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…
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…
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…
EC Proposal to delay MDR: which provisions are affected?
The European Commission proposal for the MDR delay is now officially published and accessible through:…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6…
MDR delayed for 12 months due to COVID-19?
The European Commission is proposing to delay the MDR for 12 months to fight the…
We have the 12th NB under the MDR!
Over the weekend, the European Commission updated the NANDO website and announced the designation of…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the…
Guidance on significant change for legacy devices (MDR)
All manufacturers making use of the grace period as per the Article 120 (3) of…
MDCG Joint Implementation/preparedness plan on MDR
The MDCG just publicly announced that the Actor registration will be available in EUDAMED by…
MDR: Consolidated text
We are happy to share with you that the consolidated version of the MDR –…
MDR implementation update and timeline
Update on the process CAMD Roadmap actions on the MDR Implementation 51 actions: work in…
MDR: New NB designation
The European Commission announced the 11th Notified Body designated under the Regulation (EU) 2017/745: National…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another…
Risk Management
In view of the recently published ISO 14791:2019, our experts updated the already published…
Annex XVI MDCG sub-group: Become an observer
Under the EU MDR and IVDR, the MDCG (Medical Device Coordination Group) provides advice and…
State-of-play of NB designations
The European Commission (EC) published a document on the state-of-play of designation process of Notified…
European Medical Device Nomenclature
The European Commission Unit dealing with medical devices – newly under the Directorate for Health…
Croatian Presidency of the EU
Croatia has started presiding the Council of the European Union on the 1st of January…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and…
MEDCERT designated under the MDR (9th NB)
With the below German Notified Body, designated for the assessment of devices under the MDR…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing…
MDCG Guidance for Class I manufacturers!
The MDCG published today well awaited Guidance for Class I manufacturers! The MDCG enlists tasks…
8th NB designated under MDR
NANDO database is richer for another Notified Body accreditation under the Medical Device Regulation –…
MDCG Guidance on MDR/IVDR device sampling + MDR Codes
The MDCG published two important guidance documents this afternoon. Firstly, an Explanatory note on MDR…
UDI issuing entities on Basic-UDI and UDI formats
The four accredited UDI issuing entities (which were designated by the Commission Implementing Decision of…
MDR Corrigendum: Derogation for certain up-classified devices
The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as…
6th and 7th MDR Notified Body designated
The European Commission announced two more Notified Body designations under the Medical Device Regulation in…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ”…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined…
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…
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’…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a…
DEKRA is the first NB accredited for the IVDR
This morning, the European Commission updated the NANDO database, by adding the first Notified Body…
MDCG: MDR Transitional regime
The MDCG published on Friday a guidance document, where it further clarified Article 120 (2),…
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…
5th Notified Body under the MDR!
The European Commission announced another designation of a Notified Body under the Regulation (EU) 2017/745…
Commission Implementing Decision under MDR: Expert panels
On 11 September 2019, the Official Journal of the European Union was updated with a…
Guidelines on phthalates in medical devices finalized!
Independent scientific committee SCHEER published the final Guidelines on the benefit-risk assessment of the presence…
First MDR Conformity Certificate issued
We are happy to inform you that the Notified Body BSI UK certified the first…
Another Notified Body designated under the MDR!
The European Commission published another designation of a NB under the Regulation (EU) 2017/745 on…
3rd Notified Body under the MDR!
We are happy to announce that the European Commission updated the NANDO website with a…
Recent updates to MDR e-book & MDR Deadlines
Following the clarifications from the MDCG, our MDR dedicated e-books were updated to reflect the…
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,…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing…
Implant Card under the MDR {MDCG}
The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC)…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role…
Draft EMA Guideline + MDCG Guidance to be endorsed
EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified…
MDCG on registration of devices in EUDAMED (timelines)
In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article…
MDCG on registration of ”legacy” devices
The second document related to EUDAMED was published today on the European Commission website. The…
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…
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…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent…
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…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding…
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…
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…
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…
MDCG guiding principles for issuing entities: Basic UDI-DI
MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities…
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…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under…
EC public reply to PIP fraud Petition
The European Commission (EC) published a public letter to the PIP Implants World Victims Association…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how…
TEAM-NB Survey on NB Designation process
The Team-NB performed a new survey in December and collected the data on the designation…
NB express concerns on MDR application date
Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 –…
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…
European Commission publishes NEW Information sheets
The European Commission has published today 9 Factsheets related to the MDR and IVDR. The…
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)…
Brexit and MDR: UK publishes two notices
Notice of 23 August: MDR, CE marking in “no-deal” scenario (after 29 March 2019) For…
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)…
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…
Joint Action on Market Surveillance of MD
The UK Medicines and Healthcare products Regulatory Agency and Chafea, executive agency of the European Commission…
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.…
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…
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…
EU Court decides: Software as MD
On 7 December 2017, the Court of Justice of the European Union rendered a judgment in…
1st Commission Implementing Regulation published!
After the closing of public consultations, the first Commission Implementing Regulation under MDR and IVDR…
New MDR Implementation Tools available in our E-shop !
The below two documents will help manufacturers better understand the MDR timeline, how to comply…
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…
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…
Brexit contingency plan: No-deal scenario
The UK Secretary of State for Health and Social Care sent a letter to all…
MDCG Working Groups: Tasks, Membership, Meetings
The Terms of reference of the following MDCG Working Groups were recently published: MDCG Working…
The EC requests guidelines on phthalates in certain medical devices
The European Commission has requested the Scientific committee* to provide guidelines on the benefit risk-assessment of…
NEW documents on UDI endorsed by the MDCG
The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI. 1. UDI…
Timeline on future adoption of EC Implementing Acts
The European Commission has today disclosed implementing measures rolling plan under the MDR and IVDR. The document gives…
EU Public Consultations now open: Designation of NB
Today, the European Commission has opened public consultations on the Commission Implementing Regulation on the…
Introductory guide to MDR/IVDR by the UK regulator
The British MHRA has issued an introductory guide to the MDR and IVDR, which is user-friendly and provides…
From MDD to MDR: New Transition Management Tool now on MDlaw.eu!
TMT (Transition Management Tool) is the new tool accessible on MDlaw.eu, which aims at presenting seven techniques for…
The most recent list of NB
The European Commission’s list of bodies notified under the Directive 93/42/EEC concerning medical devices can be…
Public Consultations: NB and IVD
1. The European Commission will shortly open public consultations in the context of the new…
List of MDR requirements for manufacturers!
The European Commission has published the list of requirements under the MDR that was prepared by…
Irish Authority: Practical Application of the new Regulations
The Irish Health Products Regulatory Authority (HPRA) published Information Pack on the new EU Device…
AG Opinion: software assisting health professionals to prescribe the correct treatment for patients
In the case of Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France…
EU Case-Law on medical devices
On the occasion of the ruling of the German Federal Court of Justice [Bundesgerichtshof –…
Software as MD: Regulatory guidance from UK
The UK MHRA has published the revised Guidance on medical device standalone software, including apps.…
Application dates of the Regulation on Medical Devices (MDR)
The Regulation on Medical Devices has been published in the Official Journal of the EU on 5…
Regulations on Medical Devices adopted today (5 April 2017) !
After the Council, it was today up to the European Parliament to adopt the EU…
Could economic operators quickly get clarification on whether a certain article of MDR/IVDR apply
Here some official EU links that give an answer to this question: 1. Introduction 2.…