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 ...
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 ...
MDSS receives their ISO 13485 Certificate from BSI!
We’re thrilled to announce that we have received our new ISO 13485 certification from BSI, marking a significant achievement in our commitment...
Overview of language requirements for manufacturers of medical devices
The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the ...
Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR)
This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment o...
Historic deal reached on World’s first AI Regulations – The Artificial Intelligence Act!
The Council presidency and negotiators from the European Parliament have achieved a preliminary accord on the proposal for harmonized regulations gov...
