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OSMA 2026 Spring Meeting

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

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GMED Guides

EUDAMED : Prepare for Mandatory Implementation

EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This (...)

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Webinars

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.” (...)

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Webinars

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 (...)

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GMED Guides

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 (...)

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News

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 (...)

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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, (...)

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News

Medical Fair Asia 2026

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

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Fairs

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 (...)

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News

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, (...)

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News

Medical Fair China 2026

We are pleased to announce that GMED Asia will take part in Medical Fair China 2026, held from 20 (...)

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News

RAPS Euro Convergence 2026

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

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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Newsletters

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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 (...)

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News

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) (...)

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News

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 (...)

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News

GMED at MedFIT

GMED will be attending MedFIT in Strasbourg on December 2nd and 3rd, and virtually on December 8th! MedFIT is (...)

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News

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 (...)

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Newsletters

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 (...)

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Newsletters

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 (...)

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News

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 (...)

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