The International Medical Device Regulators Forum (IMDRF) has released an updated version of its “Terminologies for Categorized Adverse Event Re...
New MIR Form (Version 7.3.1)
The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
June 2025 Deadline: Stricter UK Medical Device PMS Regulations Published
MDSS is pleased to share that Statutory Instrument 2024 No. 1368 – The Medical Devices (Post-market Surveillance Requirements) Regulations 2024 has ...
Swiss Federal Council to recognize FDA approvals / clearances — A game-changer for Medtech access!
In a landmark move, the Swiss Federal Council has decided to recognize approvals from the U.S. Food and Drug Administration (FDA), ensuring continued...
Pilot coordinated assessment for Clinical Investigation!
On March 11, 2025 the Secretariat for the Clinical Investigation / Performance Study coordinated assessment held a webinar to discuss the pilot coordi...
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...
