MDR extension has been approved, will there be room in the short term for certification of new medical devices?
The proposal to amend European Regulation 2017/745 MDR and European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting, has been approved.
The main objective of the European Medical Device Regulation (MDR) 2017/745 is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.”
The regulations significantly strengthen key elements of the previous regulatory framework set out in Council and European Parliament Directives 90/385/EEC and 93/42/EEC, such as: oversight of notified bodies, risk classification, conformity assessment procedures, and market surveillance and supervision.
Due to the impact of the Covid-19 pandemic, the implementation date of the European Regulation 2017/745 MDR was postponed by one year, to May 26, 2021, while May 26, 2024 was set as the end date of the transitional period.
Despite the steady increase in the number of notified bodies designated under European Regulation 2017/745 (MDR), the capacity of notified bodies was still found to be insufficient in ensuring conformity assessments, under MDR, due to the large number of medical devices covered by certificates issued under Directives 90/385/EEC and 93/42/EEC before May 26, 2024.
It was, therefore, anticipated that many medical devices, already covered by certificates under old directives, would not obtain compliant certification under the MDR Regulation by the end of the transition period. This would result in a consequent shortage of medical devices available on the union market: it was, therefore, necessary to extend the transition period by amending Article 120(2) (MDR).
In the coming years, a large part (if not all) of the workforce of notified bodies will be engaged in ensuring conformity assessments of the large number of medical devices already covered by certificates issued under the old directives. Given the difficulty of the current regulatory environment, it will be very likely that registration of new medical devices, under Reg. MDR, will be particularly challenging.
As a result, it would be preferable to rely on those who are already certified under the MDR and who have experience and expertise in medical device registrations for the registration of new medical devices under European Regulation 2017/745 (MDR).
This achievement is so significant because we are among the first companies in Italy to have received MDR certifications for some of our substance-based medical devices.
The achievement is the result of a long work we have been doing for two years to ensure the compliance of our medical devices in order to proactively respond to regulatory changes and promote the success of our customers.
The medical devices for which we received the first certifications under MDR Class IIb are water or oil emulsions containing simethicone, in 6 different versions.
If your company is looking for an MDR-certified medical device in ready to market line or in contract manufacturing
