15/16 February 2024
We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?
On the website, the involvement of the EMA in medical devices is presented in a relatively compact way over 8 A4 pages, divided into 7 chapters. The table of contents is as follows:
and very recently
Where available, links are provided to further EMA documents, such as Q&A documents, guidelines, marketing authorisation forms, etc. Except for the first chapter, all other chapters contain a description of the "Role of the EMA" related to the respective chapter.
The entire content can be found on the EMA website.