Knowledge Center

The European Commission has expanded the list of implantable and Class III devices that may be exempt from clinical (...)

The European Commission has expanded the list of class IIb implantable devices exempt from systematic technical documentation assessment by (...)

The 2026 MDSAP Annual Forum was held from 15 to 19 June 2026 in Kyoto and was organized by (...)

The newly published MDCG 2026-4 provides key clarifications on the management of Summary of Safety and (Clinical) Performance (SSCP/SSP) (...)

The MDCG 2021-5 Rev.1 guidance provides important clarifications on the use of symbols applicable to medical devices under the (...)

The European Commission has published Implementing Decision (EU) 2026/1313, updating harmonized standards supporting compliance with the Regulation (EU) 2017/746 (...)

The European Commission has published Implementing Decision (EU) 2026/1231, updating the harmonized standards supporting compliance with the Medical Devices (...)

GMED will be participating in MedFIT & BioFit 2026, which will take place on December the 10th and 11th (...)

GMED will be attending VivaTech, the leading event for technological innovation, taking place from June 17 to 20, 2026 (...)

Join Us at RAPS Convergence 2026 in Charlotte GMED is pleased to announce that we will be exhibiting at (...)

The global gathering for medtech returns to Boston, MA, October 18–21, 2026. Hosted by AdvaMed® (The Medtech Association), #MTC26 (...)

The purpose of this medical device change notification guide, developed by GMED, is to provide guidance on when and (...)

Commission Implementing Regulation 2017/2185 establishes the codes assignment MDR framework. This framework defines notified bodies’ scope of designation for (...)

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 certification transfer guide is designed to make your certification transfer (...)

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 (...)