News
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, held (...)
Medical Fair Asia 2026
We are pleased to announce that GMED Asia will take part in Medical Fair Asia 2026, held from 9 to (...)
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, held (...)
Medical Fair China: International Medical Exhibition for innovative Equipment, Solutions and Supplies
We are pleased to announce that GMED Asia will take part in Medical Fair China 2026, held from 20 to (...)
Euro RAPS Convergence 2026
GMED will be attending the 2026 RAPS Euro Convergence, taking place 5–8 May in Lisbon, Portugal! Visit our team at (...)
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 is (...)
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 2026, (...)
China International Medical Equipment Fair 2026 (CMEF)
We are pleased to share that Frederic Rocher, General Manager at GMED Asia, will be attending CMEF 2026, 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 Global (...)
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 in (...)
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 the (...)
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 wishes (...)
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 Diagnostic (...)
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 of (...)
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 contact (...)
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) 2017/745 (...)
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 fully (...)
GMED at MedFIT
GMED will be attending MedFIT in Strasbourg on December 2nd and 3rd, and virtually on December 8th! MedFIT is a (...)
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 drapes (...)
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 essential (...)
Team-NB Best Practice Guidance V2 on IVDR Technical Documentation Submissions (Annex II & III)
Team-NB has published the first revision of its Best Practice Guidance for the submission of technical documentation pursuant Annex II (...)
1st revision of MDCG 2024-14 guidance on the Master UDI-DI solution for contact lenses
The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)
GMED recognized as a conformity assessment body in South Africa
We are proud to announce that GMED has been recognized by the South African Health Products Regulatory Authority (SAHPRA) as (...)
GMED North America at RAPS Convergence 2025
From October 7-9, 2025, in Pittsburgh, we will be attending RAPS Convergence, a major event for regulatory professionals in the (...)
9th Annual Medical Device Global Post-Market Surveillance Conference
Join us at the 9th Annual Medical Device Post-Market Surveillance Conference in Arlington, VA hosted by Q1 Productions where Chris (...)
Artificial intelligence & healthcare: a strategic turning point for Europe
The European Commission has just published its final study on the deployment of AI in healthcare systems. This analysis highlights: (...)
NBCG-Med and Team-NB Position Paper: Notified Body Perspective on the Future Governance of the EU Medical Device Sector
This document, co-authored by the executive committees of NBCG-Med and Team-NB, reflects the common vision of notified bodies on the (...)
Team-NB Position Paper: Orphan In Vitro Diagnostic Medical Devices under the IVDR
As the EU continues to revise its pharmaceutical legislation to better address rare diseases and unmet medical needs, there is (...)
GMED at the TOPRA Symposium 2025
GMED first-time attending the TOPRA Symposium! We look forward to meeting you in Berlin, Germany, from 29 September to 1 (...)
MDCG 2025-7 Position Paper: Master UDI-DI implementation for optical devices
The Medical Device Coordination Group (MDCG) has just published Position Paper MDCG 2025-7 on Master UDI-DI implementation timelines for: Contact (...)