EU Classification Guidance Updated: Borderline Manual and MDCG 2021-24
The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are qualified…
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EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market surveillance…
MDCG Master UDI-DI Timelines: Contact Lenses and Spectacles
The Medical Device Coordination Group (MDCG) has published MDCG 2025-7 Rev. 1 (December 2025), a position…
New EU Guidance on Breakthrough Devices & IVDs
In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document introducing…
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 the…
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 highlights…
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 referenced…
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 chain…
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 Manual…
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