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

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...