On March 11, 2025 the Secretariat for the Clinical Investigation / Performance Study coordinated assessment held a webinar to discuss the pilot coordi...
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AI Act News!
The AI Act has achives its first milestone. The first phase implementation took effect on February 2, 2025. As a result, AI systems deemed to pose una...
MDR Clinical training for Manufacturers – call for participants!
TEAM-NB set up a new training for manufacturers on May 7, 2025, dedicated to clinical aspects – New Training for Manufacturers – team-nb. ...
Call for Action! Deadlines are approaching! Affected IVD Manufacturers
May 26, once again! May 26 is approaching and in 2025 marks another important date for the IVD sector. All IVD manufacturers who wish to continue sell...
Change of classification Reduced risk of SARS-CoV-2
The European Commission made an announcement for manufacturers of SARS-CoV-2 tests, after scientific advice has been received from the IVD expert pane...
Article 10a MDR/IVDR: provisions apply from 10 January 2025!
The European Commission’s newly released Q&A on Article 10a of the MDR and IVDR (Medical Device Regulation and In Vitro Diagnostic Regulation) i...
Important Updates on Swiss In-Vitro Diagnostics Ordinance!
On November 20, 2024, the Swiss Federal Council decided to align the In-Vitro Diagnostics Ordinance (IvDO) with the updated EU transition periods. Thi...
MHRA opens consultation on future UK Medical Devices Regulations!
The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a consultation on the future regulatory framework for medical devices in ...
MedTech Europe update – Manufacturer’s Declaration on EU Regulation 2024/1860
MedTech Europe has released a template to assist In Vitro Diagnostics (IVD) manufacturers in complying with Regulation (EU) 2024/1860. This reg...
EU officially publishes AI Act: Setting standards for trustworthy AI in healthcare
The AI Act was published in the Official Journal on 12 July and came into force on 2 August 2024. The provisions of the AI Act will be ...
