From today, the MDR, the new European Regulation on Medical Devices, that came into force in May 2017, has full applicability. After a one-year postponement due to Covid, it wonders how the various actors involved in the fulfilment of the new duties required by EU Regulation 2017/745 are.
Are the stakeholders ready? The answer is: not really! – says Dr. Maria Grazia Leone, (General Directorate of Medical Devices and Pharmaceutical Service, Italian Ministry of Health) during the AFI Symposium webinar this morning, 26/05/2021, the date of full applicability of the MDR.
In fact, there are still several gaps – explain the various speakers. Here they are below.
The Italian Delegation Law
It is only last month that the new Delegation Law n.53, according to which the implementation of the MDR in Italy passes from Parliament to the Government. It is therefore the responsibility of the latter to adopt legislative decrees to adapt national regulations to the transposition of the Regulation. At your disposal 12 months for the adjustment starting from the release of the Delegation Law on 22 April 2021.
The Notified Bodies, responsible for the certification of Medical Devices, under the MDR were in turn subject to recertification. However, to date, not even half is ready: the long time required for redevelopment has generated a serious shortage of suitable institutions. In fact, the European Notified Bodies, that were 56 under the directive, are now only 20 and three are on the home straight.
Several devices under the MDR change their risk class and are therefore subject to intervention by the ON for their recertification, however, this has been postponed due to the delay in the requalification of the Notified Bodies. With Regulation 561/2020, which amends the MDR regarding the dates of application, the placing on the market or putting into service of medical devices that pass from class I to a higher category is extended until 26/05/2024 and which therefore require the intervention of a Notified Body.
The Unique Devices Identifier (UDI) code, whose purpose is to facilitate the identification and traceability of medical devices, has as deadline for obtaining it the 26/05/2021, but its affixing obligation starts on 26/05/2021 for Class III DM, 26/05/2023 for DMs of Class IIa and IIb and 26/05/2025 for DMs of Class I.
Also the new European database is late: it was supposed to be online in May 2020, the first date of application of the MDR, but the official news is that it will only be active starting from May 2022. For the moment, and only for some countries, the manufacturer registration form has been opened.