Medical Device Information available on EMA's Website

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:

  • Medical devices legislation
  • Medicinal products used in combination with a medical device
  • Medical devices with an ancillary medicinal substance
  • Companion diagnostics ('in-vitro diagnostics')
  • Medical devices made of substances that are systemically absorbed
  • Borderline products

and very recently

  • High-risk medical devices

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.   

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