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Parliamentary questions
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13 November 2019
Priority question for written answer P-003802/2019
to the Commission
Rule 138
Michèle Rivasi (Verts/ALE)
 Answer in writing 
 Subject: Regulation (EU) 2017/745 on medical devices and the shortage of notified bodies in 2020

The new Regulation (EU) 2017/745 on medical devices will be fully implemented in May 2020, following a three-year transitional period. In particular, it provides for the re-assessment of notified bodies certifying the conformity of medical devices before they are placed on the market.

To date, only seven European notified bodies have received their new authorisation to affix the CE marking to products subject to monitoring. Previously there were around 50 notified bodies in Europe. The authorisation of the new notified bodies (around 20 are expected) should have been completed in December 2018.

The backlog and the shortage of operational notified bodies in Europe puts at risk the economic sustainability of medical device manufacturers awaiting approval or renewal. Furthermore, the tender specifications for clinical evaluations of class II and III medical devices, referred to as the ‘common specifications’, have not been published either.

What does the Commission intend to do to address these blockages and the shortage of notified bodies? What publication timetable can the Commission give as regards the missing ‘common specifications’? What tools will the Commission use to check the quality of the certifications issued by the notified bodies?

Original language of question: FR
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