Knowledge Center

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

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

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

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

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

GMED North America is hosting a RAPS DC/Baltimore Chapter in-person event on June 5, 2025, between 4:30 and 7:00 (...)

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

GMED will be back at RAPS Euro Convergence in 2025! From May 14-16 in Brussels (Belgium), join Julien Bouclon, (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

GMED will be attending MedFIT from December 3 to 4 at Lille and from December 11 to 12 for (...)

A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis (...)

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

Regulations (EU) 2017/745 & 2017/746 introduce “new” requirements for distributors and importers who carry out activities involving the repackaging, (...)

The guidance MDCG 2021-25 on the application of the MDR requirements to ‘legacy devices’ has been updated in order (...)

On October 8, 2024, the MDCG published a guidance that clarifies what products fall in the scope of Regulation (...)

The Commission Implementing Decisions (EU) 2024/2631 and (EU) 2024/2625 have been published in the Official Journal of the European (...)

We are delighted to announce the launch of our new format, GMED Highlights. Every month, GMED Highlights brings you (...)