In the last days, the EU Commission has presented a proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

As announced last December at EPSCO, the European Commission has formulated a proposal that introduces a longer transition period to comply with the new requirements, in order to allow more time to certify medical devices and mitigate the risk of market shortages.

Ente Certificazione Macchine, as Notified Body No. 1282 for Regulation (EU) 2017/745, is already working to better understand and implement the Commission’s proposal. In fact, in the past few days, our staff from the Medical Devices Division took part in an in-depth webinar and discussion organised by Team-NB, which involved all European Notified Bodies. The discussion highlighted the views and concerns of the attendants, as well as the desire to find shared solutions and common interpretations, in order to make the implementation of the amendments as smooth as possible.

THE PROPOSAL OF AMENDMENT

Despite the progress in the implementation of Regulations (EU) 2017/745 and (EU) 2017/746, the transition to the new regulatory regime suffers from the limited capacity of notified bodies to certify medical devices in accordance with MDR and the complex preparedness of manufacturers for the new requirements. On 6 January, therefore, the EU Commission published a proposal to amend the MDR and IVDR, which must now be examined and approved by the European Parliament and the Council in an accelerated co-decision procedure.

KEY ELEMENTS OF THE PROPOSAL

Considering that this is a conditional proposal, i.e. subject to special conditions to be fulfilled in order to benefit from the changes, the main amendments concern:

• For devices with a valid certificate issued before 26 May 2021, staggered and conditional extension of the transition period for placing on the market, depending on the risk class:
  • until 31 December 2027 for high risk devices (class III and IIb)
  • until 31 December 2028 for medium and low risk devices (class IIa and I);
• Introduction of a transitional period until 26 May 2026 for custom-made implantable class III devices, to give manufacturers more time to obtain certification by a notified body (provided the manufacturer has submitted an application for assessment to a notified body by 26 May 2024);
• Extension of the validity of EC certificates issued until 26 May 2021, the date of entry into force of the Medical Devices Regulation, to reflect the transition periods put forward by amendments,
• Elimination of the sell-off date currently established in the MDR and IVDR, to ensure that medical devices already on the market remain available to the healthcare system and avoid shortages.

ECM SERVICES

As Notified Body No. 1282 for Regulation (EU) 2017/745, ECM accepts new certification applications to assess the compliance of medical devices with MDR requirements. Thanks to the efforts of our experts, at the end of the year we were very pleased to issue the first certificate under Regulation (EU) 2017/745. Our EU conformity assessment work is proceeding at full speed and, considering the complexity of the activities, we invite manufacturers to contact us as soon as possible to start the certification process. Indeed, the Commission’s proposal states that the extension will be subject to certain conditions, in order to ensure that only devices that are safe and for which manufacturers have already taken measures to transition to the new regulations, can benefit from the additional time.