MDCG 2025-8 and the New Master UDI-DI Requirements
The Medical Device Coordination Group (MDCG) has published MDCG 2025-8, a comprehensive guidance document on…
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What Are France-Specific Medical Device Requirements?
Navigate France's unique medical device regulations beyond CE marking with ANSM compliance insights.
The EU AI Act and Notified Bodies
As highlighted earlier this year, Team-NB published an updated version of their Position Paper on “European Artificial Intelligence Act (AI ACT)”, it…
How Do I Sell Medical Devices in Belgium?
Complete guide to Belgian medical device regulations, CE marking requirements, and market entry strategies.
EU Decision 2025/2078: Harmonized Medical Standards Update
The European Commission published Implementing Decision (EU) 2025/2078, amending Implementing Decision (EU) 2021/1182 by adding the following harmonized standards…
Expanding into EU Market with MedEnvoy Support
Expanding into the European and UK markets can feel overwhelming, especially with the complex documentation, compliance requirements, and supply…
Manual on Borderline and Classification Under the IVDR and MDR
The Borderline and Classification Working Group (BCWG) has released Version 4 (September 2025) of the…
CE Marking Support: MedEnvoy Partnership
At MedEnvoy, we take pride in helping innovative companies bring their medical devices to market with confidence, with CE…
EU Launches Evidence on Targeted Revision of MDR and IVDR
The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation…
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