From the date of application of the EU Medical Device Regulation (EU) 2017/745 (MDR), 26th of May 2021, new medical devices and class I devices placed on the EU markets shall comply the requirements of the Regulation. However, some devices may still be placed on the EU markets under the Medical Devices Directives as so-called legacy devices. This is possible as the Article 120(2) and 120(3) of the EU MDR state that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the EU MDR under certain conditions.
For these legacy products, it is required that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance in respect of all the applicable requirements relating to the devices it has certified. The MDCG’s guidance document describes in more detail what is meant by “appropriate surveillance” and which aspects are under the surveillance of the notified body.
Even though products are on the EU markets under the Directives, manufacturers shall also identify and implement all relevant requirements on post-market surveillance, vigilance and registration of economic operators/devices set out in the MDR. These EU MDR requirements will now be subject to the notified body’s surveillance activities.
It is noteworthy, that Article 110(3) of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is outside the scope of the MDCG ‘s guidance document. However, the principles outlined in the guidance text that are common between the EU legislation for medical devices and in vitro diagnostic medical devices may be applied also to the activities that are to be performed by the notified bodies based on the Article 110(3) of the IVDR.
Link to the MDCG’s guidance document: https://ec.europa.eu/health/system/files/2022-02/mdcg_2022-4_en.pdf