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...
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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...
