Team NB Position Paper: IVDR Certification Process
Team NB IVDR certification guidance outlines pre-application and application procedures for IVDs.
Resources & News
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New Team NB Position Paper on EU AI Act
Team NB’s updated position paper on the EU AI Act outlines key implementation challenges and solutions for medical devices.
Swiss Medtech Holds US Tariff Webinar
Swiss Medtech is now offering a webinar on US Tariffs on May 21 to explore the impact of US tariffs on the medtech industry.
New Open Letter to European Commission Regarding US Tariffs
European Commission urged to act on US tariffs threatening Europe's medical technology sector.
New FDA-Approval Process for Swiss Device Market Entry
Learn about the Swiss FDA approval process as the Swiss government works to simplify medical device regulations.
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.
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 EU…
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