New Team NB Paper on Technical Documentation Submission
Discover key updates in Team NB's 2025 guidance on MDR Annex II & III technical documentation, including Clinical, PMS changes, and more.
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Update on COVID-19 Test Classification in the EU
The MDCG has updated COVID-19 test classifications, reclassifying them from Class D to Class B or C.
E&E CML Limited Added to UK List of Approved Bodies
Eurofins E&E CML is now a UK approved body under the UK Medical Devices Regulations 2002.
Team NB Upcoming MDR/IVDR Trainings
Team NB recently announced two new remote training sessions designed to help manufacturers strengthen their understanding and compliance with…
New Swissdamed FAQs with EMDN and UDI Info
Swissmedic updates Swissdamed FAQ with new details on Actor Registration, UDI modules, and more.
EUDAMED Free Training From The European Commission
The European Commission is hosting a free training workshop in Stuttgart to prepare for EUDAMED onboarding.
New EU Harmonized Standards for the MDR and IVDR
Harmonized standards in the European Union (EU) play a crucial role in ensuring that products, services, and processes…
Switzerland to Approve FDA-Certified Medical Devices in 2025
In Q2 2025, the Federal Council will decide how and at what pace it will implement the Müller motion…
ISO 15223-1 Amendment 1:2025 Updates for Medical Devices
As your Global Partner for Medical Device Regulatory Compliance, MedEnvoy would like to notify manufacturers that the…
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