In January, the European Commission published a proposal for another amendment to the MDR and IVDR, which brings a number of major new...

A major issue for healthcare providers is the application of Article 5(5) of the IVDR. The issue is that in many cases clinical...

On Friday, 19 January 2024, the Ministry of Health held a meeting of the Stakeholder Platform on the issue of medical device regulation....

On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final...

We can infer where the medical device market will go in 2024 from the previous year's news. At least partially. The year 2023 would...