Category - delegated act


Trilogue MDR/IVDR will probably not complete this year

With the end of the political year in Brussels in sight I though it would be a good idea to give you an update on process (if you can call it that) in the trilogue for the MDR and IVDR. Work on implementation by delegated and implementing acts Let’s start with the good news:  a […]


“S” is for scope: does that include to ‘enhance’?

The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal. […]