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New EU Harmonized Standards for Medical Device Sterilizers, Steam Boilers and Hearing Aids

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

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AMDM IVD Regulatory Submissions Workshop

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

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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 it (...)

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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 GMED (...)

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The 34th China International Health Industry Expo 2026 (Guangzhou Yi Fan Exhibition Co.,Ltd.)

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

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Medical Fair Asia 2026

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

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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 Healthcare (...)

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Shanghai International Medical Devices Exhibition 2026 (Shanghai Juyi Exhibition Service)

We are pleased to announce that GMED Asia will take part in the Shanghai International Medical Devices Exhibition 2026, held (...)

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Medical Fair China 2026

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

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RAPS Euro Convergence 2026

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

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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 (...)

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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, (...)

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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 the (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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GMED at MedFIT

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

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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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 (...)

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