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 ...
Integration of Mandates in Swissdamed!
The Swiss medical device database – swissdamed has gone live this month and actor registrations are open for Swiss entities. For foreign manufacture...
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...
Swissmedic announces new Swissdamed Database!
Swissmedic is pleased to announce the launch of Swissdamed, a new database designed to support the implementation of Swiss regulations for medi...
