Europe – MDCG 2019 -10 : Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

According to Article 120(2) of Regulation (EU) 2017/745 on Medical Devices (the MDR), certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC (the Directives) will remain valid until 27 May 2024 at the latest. However, Article 120(3) establishes specific conditions that such certificates, and the related devices thereof, have to comply with. In particular, it is required that the notified body that issued the certificate – under a valid designation – continues to be responsible for the appropriate surveillance activities with respect to all of the applicable requirements related to the devices it has certified and that it has the possibility to take any necessary measure in relation to

It has to be noted that, as reported in FAQ n.17 of the MDR transitional provision document
published by the CAMD Transition Sub Group, the contract between the manufacturer and the notified body who issued the certificate under the relevant Directive shall include provisions allowing the appropriate performance of such surveillance activities.

In order to allow manufacturers to take advantage of Art. 120(2) and Art. 120(3) of the MDR, it needs to be ensured that Authorities responsible for notified bodies have the right to and do monitor those notified body’s activities to the extent appropriate and necessary. For this purpose, Article 120(3) and Article 122(1) of the MDR provide the necessary legal basis for Member States to establish the necessary legal empowerments by means of National law to carry out the needed monitoring activities in relation to Notified Bodies. All this is regardless of whether the Notified Body has applied or not to be designated under the MDR and/or it has a still valid designation under the Directives during the validity of certificates issued in accordance to the Directives…