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Parliamentary questions
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18 April 2019
P-001126/2019(ASW)
Answer given by Ms Bieńkowska on behalf of the European Commission
Question reference: P-001126/2019

1. The certificates issued under the Medical Device Directives will remain valid until 27 May 2024 at the latest. Therefore, the devices certified under the old Directives do not need to be re-certified by the repeal dates of the directives (respectively 26 May 2020(1) and 26 May 2022(2)).

There are approximately 55 000 certificates issued under the old Directives. The number of devices that will require a certification under the new Regulations will not be the same as the number of certificates issued under the directives because the regulations require a certification of some additional categories of devices. Moreover, certificates can cover more than one device.

2. At this stage, one notified body, BSI Assurance UK Ltd (NB 0086), established in the United Kingdom (UK), has been designated under Regulation 2017/745, as reflected in the New Approach Notified and Designated Organisations (NANDO) database(3).

According to the most recent data, there have been 37 pending applications for designation under Regulation 2017/745 (two of which from UK bodies) and nine pending applications for designation under Regulation 2017/746 (one of which from a UK body) submitted to the Commission. The overall data on the designation process are publicly available and updated regularly(4).

3. The Commission and the EU-27 Member States are closely monitoring the situation, in particular the ongoing transfer of certificates from UK-based bodies to EU-27 bodies, in order to be able to identify in a timely manner, based on country and product-specific evidence, any possible risk of shortage of supplies of individual critical medical devices.

No concrete risk has been identified so far.

(1)Directives 90/385/EEC and 93/42/EEC.
(2)Directive 98/79/EC.
(3)NANDO Information System at http://ec.europa.eu/growth/tools-databases/nando/
(4)https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en

Last updated: 18 April 2019Legal notice