European Commission - Draft of Implementing Regulation open for comments

The European Commission's 'Have your say' portal has opened on its website the document „Common specifications for in vitro diagnostic medical devices“, which is open for comments until 16.9.2024.

It concerns some selected Class D devices for which there are currently no harmonised standards and therefore it was necessary to create some specifications and update others according to the state of the art.

The consultation for comments is available in the following link: Common specifications for in vitro diagnostic medical devices