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...

The turn of the year is always accompanied by some kind of taking stock of what has happened in the past year. As far as the medical...

On Monday 19 June 2023, another meeting of the platform at the Ministry of Health took place, where representatives of regulators, health...

On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council came into force, amending the MDR and IVDR. The...

For a long time, nothing has been heard about the consultation process for clinical investigation of high-risk devices. As a reminder,...

There is a growing tendency in the field of medical device to shift responsibilities from the manufacturer to the rest of the...

In the second half of January, the Constitutional Court issued a fairly inconspicuous but absolutely crucial decision for real practice....

On 15 February 2023, the European Parliament has almost unanimously supported a proposal to amend the EU Medical Devices and In Vitro...

On 6 January 2023, the European Commission adopted a proposal to extend the transition period for the re-certification of so-called...