The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
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...
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...
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...
Important News for IVD and MD Manufacturers!
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to info...
Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!
New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essentia...
Guidance for Clinical Investigation Plan under MDR: Key Highlights!
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
Commission proposal on extending IVDR transition and expediting EUDAMED adoption!
Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the al...
