Knowledge Center

The new official platform mdsap.global, developed by the Regulatory Authority Council behind the MDSAP, is now live. It offers manufacturers (...)

The ISO 10993 series provides a framework for the biological evaluation of all medical devices (MDs) that come into direct (...)

The European Commission has recently published the MIR 7.3.1 form, which will be required to use from November 2025 for (...)

Team-NB published an updated version of its Position Paper on the European Artificial Intelligence Act. It aims to present its (...)

The Team-NB Position Paper on the certification process under Regulation (EU) 2017/746 aims to provide a harmonized and detailed framework (...)

In this video, Tom Patten, GMED International IVDR Manager, covers some of the upcoming crucial dates for IVD manufacturers, including: May 26, (...)

Team-NB published an updated version of its Position Paper “Best practice guidance for the submission of technical documentation under Annex (...)

The Post-Market Surveillance (PMS) system is an essential process for ensuring the safety and effectiveness of medical devices placed on (...)

GMED will be at the MedTech Forum, Europe’s leading healthcare and medical technology conference. Come meet our team at booth (...)

The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)

Regulation (EU) 2025/327 on the European Health Data Space (#EHDS) and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 was published (...)

The Medical Device Single Audit Program (MDSAP) initiative started in 2012 and has been fully operational in 2017. Since then, (...)

In February 2025, the European Commission, after consultation with the Member States in the Medical Device Coordination Group (MDCG), launched (...)

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. (...)

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

GMED will be back at RAPS Euro Convergence in 2025! From May 14-15 in Brussels (Belgium), join Béatrice Lys, Technical (...)

This guide presents the key stages of the certification process under Regulation (EU) 2017/745 set up by GMED. It guides (...)

The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical (...)

The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR (...)

The annual revision of the EMDN ensures that MD nomenclature incorporates the latest innovations, ensuring accurate classification. These updates ensure (...)

Since the early 2000s, particularly in Europe, there has been a growing awareness of the impact of chemical substances on (...)

From Paris to Washington D.C., via London and Hong Kong, all our teams would like to thank you for the (...)

The MDCG has just published a form for manufacturers to report interruptions or discontinuation of the supply of certain IVDs (...)

The European Commission has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (...)

The European Commission has launched a public consultation and call for evidence on the European Regulation on medical devices and (...)

The involvement of European Union Reference Laboratories (EURLs) is a new requirement described in Article 100 of Regulation (EU) 2017/746 (...)

In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and (...)

The European Commission has published a Q&A on the practical aspects related to the implementation of the obligations, laid down (...)

The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the (...)

On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on (...)