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Parliamentary questions
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1 March 2019
Question for written answer P-001126-19
to the Commission
Rule 130
Dario Tamburrano (EFDD)

 Subject:  Medical devices
 Answer in writing 

Regulation (EU) 2017/745 states that medical devices already on the market have to obtain a new certificate from ‘notified bodies’ that have been accredited on the basis of criteria laid down in that regulation. Medical devices that have not obtained their new certificate by May 2020 will no longer be able to be marketed, although some derogations are allowed up to 2024.

Regulation (EU) 2017/745 replaces two earlier directives. To the best of our knowledge, there are still dozens and dozens of certification ‘notified bodies’ in existence that were established on the basis of those two earlier directives. A substantial amount of the certification work has been carried out in Great Britain.

Health professionals and firms manufacturing medical devices maintain, given too the complexity of the services required, that the ‘notified bodies’ established on the basis of Regulation (EU) 2017/745 may be going to start work too late to be able to certify all medical devices in time.

Can the Commission say therefore:
1. How many medical devices are there that are certified at present and will, therefore, have to obtain a new certificate?
2. How many ‘notified bodies’ have been accredited so far under Regulation (EU) 2017/745 and how many have started the accreditation procedure? In both cases, how many of them are in Great Britain?
3. How will the Commission avert the risk of a serious stoppage in the availability of medical devices for clinical use, with serious repercussions for citizens?
Original language of question: IT 
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