To meet the concerns of manufacturers and notified bodies, the European Commission has committed to submit new solution proposals to deal with the significant challenges related to the implementation of Regulation (EU) 2017/745.

In recent years, concerns have been expressed on several fronts by the medical device industry about the level of preparedness of manufacturers and the insufficient capacity of notified bodies to certify medical devices in accordance with the MDR within the transition period.

In light of the complex and urgent situation, the European Commission has listened attentively to these concerns and is ready to provide solutions to facilitate the transition of the entire system to the new regulation and avoid shortages of medical devices on the European market.

ECM’S INVOLVEMENT IN THE REGULATORY ARENA

Ente Certificazione Macchine is directly involved in the institutional meetings at the European level as Notified Body No. 1282 for the Medical Devices Regulation (EU) 2017/745, bringing its contribution to the decision-making process that will define the future legislative framework. In the last few days the ECM Medical Devices Division staff Vanessa Biavati – Division Manager and Tatiana Vignudelli – ISO17021-1 scheme manager, vice MDD and MDR scheme manager, lead auditor, product reviewer, final reviewer, Chiara Dall’Olio – Project Leader and Giacomo Golfieri – Quality Assurance Manager, attended two important sessions:

• the update webinar organised by Team-NB and NBCG-Med,
• the meeting organised by the Ministry of Health with the Italian Notified Bodies.

During the events, the institutions confirmed the possibility of changes in MDR transition timelines, underlining the Commission’s commitment to ensure effective and timely solutions to guarantee the correct implementation of the new regulatory framework.

THE POSSIBLE SCENARIOS

At the EPSCO Health Council on 9 December 2022, the European Commission committed to present the likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR. According to the Note of 6 December 2022, the legislative proposal is based on the input received so far from national experts and stakeholders and could include:

• an extension of the transitional period in Article 120(3) of the MDR with staggered deadlines depending on the risk class. The deadlines could be 2027 for class III and class IIb devices and 2028 for class IIa and class I devices, which require the involvement of a notified body in the conformity assessment;
• the extension of the transitional period could be combined with an extension of the validity of certificates issued under the MDD and AIMD.

THE SERVICES OF ECM

ECM, acting as Notified Body No. 1282, accepts new applications from companies wishing to certify their medical devices under the MDR. In light of the complexity of the MDR requirements and the current situation in continuous update, we invite manufacturers to contact us as soon as possible for more information, to find out the timeline of the certification process and to get a tailor-made quote.

Contact us at: Eng. Diego Stevanella diego.s@entecerma.it | tel. (+39) 3932471040