December 4, 2019

Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives

On May 26, 2020, the new Medical Device Regulation 2017/745/EU (“MDR”) will enter into force. Under Article 120.2, certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC will remain valid until 27 May 2024 at the latest.

Nevertheless, there are specific conditions to extend the validity of those certificates during the interim period.

Specifically, notified bodies remain in charge of implementing appropriate surveillance measures with reference to the certified requirements. Accordingly, as stated in FAQ No. 17 of the MDR transitional provision document published by the CAMD Transition Sub Group, such controls should become part of specific contractual provisions between manufacturers and notified bodies allowing these latter to carry on such activities.

On the other hand, in order to allow manufacturers to apply Articles 120.2 and 120.3 of the MDR, the Authorities responsible for notified bodies (in Italy the Ministry of Health) must monitor their activities. To this aim, Articles 120.3 and 122.1 of the MDR provide the necessary legal basis for Member States to implement relevant national legislative measures. This interim regulatory framework will involve all notified bodies and not only those designated under the new MDR.

Therefore, after 25 May 2020, in accordance with Article 120.1 of the MDR, the NANDO Database (New Approach Notified and Designated Organization) relating to the former directives will become void while remaining available for information purposes only and the notified bodies listed therein will only be entitled to perform surveillance activities on existing certificates during the transitional period.

It is interesting to note that to date, there are only 7 notified bodies already listed in the new MDR NANDO Database while just 2 are designated under Regulation 2017/746/EU on in vitro diagnostic medical devices.

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