News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  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 to (...)

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

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

We are pleased to announce that Frederic Rocher, General Manager at GMED Asia, will be present at the CACLP 2026, (...)

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