When discussing medical device regulation, it is often said that Class I and IIa devices do not need to be accompanied by instructions...

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....