The European Medicines Agency (EMA) has recently pubblished the first guideline dedicated to in vitro medical devices, which begins to better outline the processes, roles and responsibilities that Ema and the competent authorities at national level will be called to assume in the light of the next, definitive entry into force of the new European regulation on medical devices (reg. EU 2017/745) and of that on in vitro diagnostics (reg. EU 2017/746) (in May 2020 and 2022, respectively).

The big challenge we face is to ensure that we have the appropriate experience and resources to perform these new tasks adequately,” commented Ema’s general manager, Guido Rasi.

Focus on article 117

The first guideline, in the form of Questions and answers (Q&A), is particularly focused on article 117 on the new Regulation that introduces a new requirement for notified body involvement in a medicinal product with an integral medical device.

The guideline is organised as follow:

1. What is Article 117 and what does it mean for medicinal products?
2. How will the medical devices Regulation and in particular Article 117 impact new
marketing authorisation applications?
3. When is it required to provide the notified body opinion/ EU certificate / declaration of
conformity with my Marketing Authorisation Application (MAA)?
4. When the company has to submit the notified body opinion?
5. How does Article 117 of the medical devices regulation impact currently authorised
medicinal products with an integral medical device?
6. When the company has to provide a (new or updated) EU certificate / declaration of conformity /notified body opinion if there are changes to the device submitted through a variation /extension?

The Q&A is a living document that will be updated continuously, and will be marked by “NEW” or “Rev.” with the relevant date upon publication.

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