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
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
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.…