Knowledge Center

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices (...)

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices (...)

The MDCG has published Revision 2 of the MDCG 2021-12 guidance, dedicated to the FAQ on the European Medical (...)

The European Commission has published updated reference documents related to Article 10a of the MDR and IVDR, addressing the (...)

The European Commission has released an updated Manufacturer Incident Report (MIR) form. The use of MIR version 7.3.1 becomes (...)

The MDCG 2026‑1 provides an overview of the EMDN update requests submitted in 2025, together with the decisions taken (...)

A new version of the Manual on Borderline and Classification under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) has (...)

A valid Class C application is necessary to maintain your transitional timeline — but it is not, by itself, (...)

The Medical Device Coordination Group (MDCG) has published Revision 1 of MDCG 2021‑24, the guidance dedicated to the classification (...)

The European Commission has published Implementing Decision (EU) 2026/760, updating the list of harmonized standards supporting compliance with the (...)

GMED at AMDM’s IVD Regulatory Submissions Workshop 21 April 2026 | North Bethesda, MD, USA GMED is pleased to (...)

GMED at the 2026 OSMA Spring Meeting 21–23 April 2026 | Washington, D.C. GMED is pleased to announce that (...)

EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This (...)

GMED will participate in the Spring Symposium 2026, titled “RWE‑Driven MedTech: Cross‑Sector Perspectives on Building Cost‑Effective Clinical Evidence Strategies.” (...)

In collaboration with MedTech Leading Voice and AKRA TEAM, a webinar will be held to discuss the European Commission’s (...)

Thinking about transferring your certification to GMED? Our comprehensive guide is designed to make your transition simple, secure, and (...)

GMED at the 2026 US Medical Device & Diagnostic Post-Market Surveillance, Vigilance Conference 24–26 March 2026 | Boston, MA (...)

We are pleased to announce that GMED Asia will take part in the 34th China International Health Industry Expo, (...)

We are pleased to announce that GMED Asia will take part in Medical Fair Asia 2026, held from 9 (...)

  We are pleased to announce that GMED Asia will take part in the Hong Kong International Medical and (...)

We are pleased to announce that GMED Asia will take part in the Shanghai International Medical Devices Exhibition 2026, (...)

We are pleased to announce that GMED Asia will take part in Medical Fair China 2026, held from 20 (...)

GMED will be attending the 2026 RAPS Euro Convergence, taking place 5–8 May in Lisbon, Portugal! Visit our team (...)

GMED at the 2026 US Medical Device & Diagnostic Clinical Evidence Conference 24–26 March 2026 | Boston, MA GMED (...)

We are pleased to announce that Frederic Rocher, General Manager at GMED Asia, will be present at the CACLP (...)

We are pleased to share that Frederic Rocher, General Manager at GMED Asia, will be attending CMEF, one of (...)

GMED is pleased to announce that Shahriar Sharifi and Florianne Torset-Bonfillou will be representing our organization at the forthcoming (...)

The European Commission has just published Implementing Decision (EU) 2026/197, marking a step forward for the regulatory framework governing (...)

On 30 January 2026, the European Commission published Implementing Decision (EU) 2026/193, updating the list of harmonized standards supporting (...)

Demonstrating the safety and performance of non-active surgical implants relies on rigorous preclinical data, guided by constantly evolving standards (...)