News

From October 13 to 15, 2026, GMED will participate in the 37th A3P International Congress, taking place in Biarritz, France. (...)

        GMED expert Tom Patten to share insights on a simpler digital regulatory future On November 4, (...)

          GMED expert Tom Patten to take part in Notified Bodies Q&A Tom Patten, IVD International (...)

The MDCG has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under the IVDR, providing (...)

GMED Expert Shahriar Sharifi to Share Insights on ISO 10993-1:2025 and Evolving Biocompatibility Expectations Shahriar Sharifi, PhD, GMED expert in (...)

GMED Expert Tom Patten to Present on Lessons Learned from IVDR Notified Body Assessments Tom Patten, IVD International Manager at (...)

We are pleased to announce that GMED will be participating in the 9th Edition US Medical Device & Diagnostic Supplier (...)

The MDCG has published a new position paper clarifying the assignment of Unique Device Identifiers (UDI-DI) between manufacturers and distributors (...)

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 (...)