News
New serious incident reporting form for medical device manufacturers (MIR 7.3.1)
The European Commission has recently published the MIR 7.3.1 form, which will be required to use from November 2025 for (...)
Team-NB Position Paper on the European Artificial Intelligence Act (v2)
Team-NB published an updated version of its Position Paper on the European Artificial Intelligence Act. It aims to present its (...)
Team-NB Position Paper on the certification process under Regulation (EU) 2017/746
The Team-NB Position Paper on the certification process under Regulation (EU) 2017/746 aims to provide a harmonized and detailed framework (...)
Upcoming Key Dates for IVD Manufacturers in 2025
In this video, Tom Patten, GMED International IVDR Manager, covers some of the upcoming crucial dates for IVD manufacturers, including: May 26, (...)
Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (v3)
Team-NB published an updated version of its Position Paper “Best practice guidance for the submission of technical documentation under Annex (...)
GMED at The MedTech Forum 2025
GMED will be at the MedTech Forum, Europe’s leading healthcare and medical technology conference. Come meet our team at booth (...)
4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)
Publication in the OJEU of Regulation (EU) 2025/327 on the European Health Data Space
Regulation (EU) 2025/327 on the European Health Data Space (#EHDS) and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 was published (...)
2nd call launched by the European Commission for applications for EURLs on high-risk IVDs
In February 2025, the European Commission, after consultation with the Member States in the Medical Device Coordination Group (MDCG), launched (...)
RAPS DC/Baltimore Chapter: Unlocking the Potential of MDSAP – Quality, Regulatory, and Commercial Advantages
GMED North America is hosting a RAPS DC/Baltimore Chapter in-person event on June 5, 2025, between 4:30 and 7:00 p.m. (...)
European Commission Newsletter on medical devices | February 2025
This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)
GMED at RAPS Euro Convergence 2025
GMED will be back at RAPS Euro Convergence in 2025! From May 14-15 in Brussels (Belgium), join Béatrice Lys, Technical (...)
European Medicines Agency Q&A guidance on the implementation of the MDR and IVDR update
The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical (...)
5th revision of the MDCG 2019-6: Q&A on the requirements relating to NBs
The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR (...)
Latest European Medical Device Nomenclature update
The annual revision of the EMDN ensures that MD nomenclature incorporates the latest innovations, ensuring accurate classification. These updates ensure (...)
Heading for 2025: Best wishes from the 4 corners of the world!
From Paris to Washington D.C., via London and Hong Kong, all our teams would like to thank you for the (...)
MDCG 2024-16: Form and Annex for manufacturer’s information on the interruption or cessation of supply of certain MDs and IVDs
The MDCG has just published a form for manufacturers to report interruptions or discontinuation of the supply of certain IVDs (...)
Q&A on gradual roll-out of EUDAMED
The European Commission has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (...)
MDR & IVDR: Have your say!
The European Commission has launched a public consultation and call for evidence on the European Regulation on medical devices and (...)
First revision of the MDCG 2023-3: Q&A on vigilance terms and concepts as outlined in the Regulations (EU) 20217/745 and 2017/746
In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and (...)
Q&A on the obligation to inform in case of interruption or discontinuation of supply of certain MDs and IVDs
The European Commission has published a Q&A on the practical aspects related to the implementation of the obligations, laid down (...)
Guide MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the (...)
GMED at MedFIT
GMED will be attending MedFIT from December 3 to 4 at Lille and from December 11 to 12 for online (...)
Updated Draft Statutory Instrument for Post-Market Surveillance: Gap Analysis
A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis to (...)
European Commission Newsletter on medical devices | October 2024
This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)
Revision of the guidance MDCG 2021-25 on the application of the Regulation (EU) 2017/745 (MDR) requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
The guidance MDCG 2021-25 on the application of the MDR requirements to ‘legacy devices’ has been updated in order to (...)
MDCG 2024-11 guidance on qualification of in vitro diagnostic medical devices
On October 8, 2024, the MDCG published a guidance that clarifies what products fall in the scope of Regulation (UE) 2017/746 (...)
Update of the list of harmonized standards under Regulations (EU) 2017/745 (MDR) and (EU) 2017/76 (IVDR)
The Commission Implementing Decisions (EU) 2024/2631 and (EU) 2024/2625 have been published in the Official Journal of the European Union (...)
GMED Highlights: launch our new monthly format
We are delighted to announce the launch of our new format, GMED Highlights. Every month, GMED Highlights brings you a (...)
Creation of subsidiary GMED Asia: GMED continues to expand internationally
GMED, a subsidiary of the LNE group, is expanding its certification business with the creation of GMED Asia, based in (...)