Knowledge Center
View all our technical, regulatory and normative information including guides, webinars, news...
Articles
OSMA 2026 Spring Meeting
GMED at the 2026 OSMA Spring Meeting 21–23 April 2026 | Washington, D.C. GMED is pleased to announce that (...)
EUDAMED : Prepare for Mandatory Implementation
EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This (...)
RWE-Driven MedTech: Cross-Sector Perspectives on Building Cost-Effective Clinical Evidence Strategies
GMED will participate in the Spring Symposium 2026, titled “RWE‑Driven MedTech: Cross‑Sector Perspectives on Building Cost‑Effective Clinical Evidence Strategies.” (...)
IVDR Proposed Revision: Practical Breakdown & Implications for IVD Manufacturers
In collaboration with MedTech Leading Voice and AKRA TEAM, a webinar will be held to discuss the European Commission’s (...)
Voluntary or regulatory certification transfer application
Thinking about transferring your certification to GMED? Our comprehensive guide is designed to make your transition simple, secure, and (...)
2026 US Medical Device & Diagnostic Post-Market Surveillance, Vigilance Conference
GMED at the 2026 US Medical Device & Diagnostic Post-Market Surveillance, Vigilance Conference 24–26 March 2026 | Boston, MA (...)
The 34th China International Health Industry Expo 2026
We are pleased to announce that GMED Asia will take part in the 34th China International Health Industry Expo, (...)
Medical Fair Asia 2026
We are pleased to announce that GMED Asia will take part in Medical Fair Asia 2026, held from 9 (...)
Hong Kong International Medical and Healthcare Fair
We are pleased to announce that GMED Asia will take part in the Hong Kong International Medical and (...)
Shanghai International Medical Devices Exhibition 2026
We are pleased to announce that GMED Asia will take part in the Shanghai International Medical Devices Exhibition 2026, (...)
Medical Fair China 2026
We are pleased to announce that GMED Asia will take part in Medical Fair China 2026, held from 20 (...)
RAPS Euro Convergence 2026
GMED will be attending the 2026 RAPS Euro Convergence, taking place 5–8 May in Lisbon, Portugal! Visit our team (...)
2026 US Medical Device & Diagnostic Clinical Evidence Conference
GMED at the 2026 US Medical Device & Diagnostic Clinical Evidence Conference 24–26 March 2026 | Boston, MA GMED (...)
The 23rd China International In Vitro Diagnostic Expo (CACLP)
We are pleased to announce that Frederic Rocher, General Manager at GMED Asia, will be present at the CACLP (...)
China International Medical Equipment Fair (CMEF)
We are pleased to share that Frederic Rocher, General Manager at GMED Asia, will be attending CMEF, one of (...)
GMED at the Global Regulatory Strategy Conference in Baltimore
GMED is pleased to announce that Shahriar Sharifi and Florianne Torset-Bonfillou will be representing our organization at the forthcoming (...)
New EU Harmonized Standards for Sterilization Processes and IVD Labelling Requirements
The European Commission has just published Implementing Decision (EU) 2026/197, marking a step forward for the regulatory framework governing (...)
New Harmonized Standards Added Under EU MDR
On 30 January 2026, the European Commission published Implementing Decision (EU) 2026/193, updating the list of harmonized standards supporting (...)
Safety and performance of non-active implants: how to meet the preclinical requirements of Regulation (EU) 2017/745?
Demonstrating the safety and performance of non-active surgical implants relies on rigorous preclinical data, guided by constantly evolving standards (...)
2026: Innovating Together for a Safer World
As we step into this new year, our teams in Paris, Washington, D.C., and Hong Kong extend their best (...)
MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
The Medical Device Coordination Group (MDCG) has released its new guidance: “Post-Market Surveillance of Medical Devices and In Vitro (...)
Implementing Regulation (EU) 2025/2526: Correction and Designation of EU Reference Laboratories for In Vitro Diagnostic Medical Devices
The Commission Implementing Regulation (EU) 2025/2526, published on 17 December 2025, amends Regulation (EU) 2023/2713 to correct the designation (...)
MDCG 2025-7 Rev. 1: Implementation Timeline for Master UDI-DI for Contact Lenses and Eyewear
The Revision 1 of MDCG 2025-7, published in December 2025, clarifies the key dates for implementing Master UDI-DI for (...)
New Guidance MDCG 2025-9: Accelerating Access to Breakthrough Medical Devices in Europe
The Medical Device Coordination Group (MDCG) has published its 2025-9 guidance on Breakthrough Devices (BtX) under the Regulations (EU) (...)
EUDAMED: 1st four fully functional modules
The European Commission has officially declared that 4 modules within the European Database on Medical Devices (EUDAMED) are now (...)
GMED at MedFIT
GMED will be attending MedFIT in Strasbourg on December 2nd and 3rd, and virtually on December 8th! MedFIT is (...)
New Harmonized Standards for Medical Devices
On October 17, 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, updating harmonized standards for: Surgical clothing and (...)
AI Act and medical devices: GMED clarifies the stakes
Regulation (EU) 2024/1689 on artificial intelligence, or the AI Act, marks a new step in the framework of artificial (...)
Article 117 of Regulation (EU) 2017/745: What you need to know about placing combined drug-device products on the market
Many medicinal products are designed for use with a medical device or part of a medical device. Given the (...)
Version 4 of the Manual on borderline and classification for medical devices (Sept. 2025)
This reference document, developed by the Borderline and Classification Working Group (subgroup of the Medical Device Coordination Group), provides (...)