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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.
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.
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:
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.
Contact us for more information at:
Eng. Diego Stevanella – Sales Manager ECM firstname.lastname@example.org| mob. (+39) 393 2471040