Medical Device Information available on EMA's Website
Recommendation
5-7 May 2025
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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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