Last November, the European Commission published a corrigendum to the Medical Device Regulation (MDR), the content of which was taken up and explained in more detail by the Medical Device Coordination Group (MDCG) in a guide (Guide: MDCG 2020-2 Class I Transitional provisions under Article 120 [3 and 4] MDR). Among others, Class I medical devices are affected by the change. Those manufacturers who previously had to comply with the requirements of the MDR until the sole date of application of the regulation now have greater leeway to revise their products in accordance with the requirements of the MDR. To this end, Article 120 has been amended with respect to paragraphs 3 and 4.
This guidance still assumes that the implementation period for many of the requirements imposed on medical devices by the European Medical Devices Regulation will end in the current year. However, due to the COVID 19 pandemic, the European Union has now decided to postpone the date of application of the regulation by another year. The start date of the regulation has thus been postponed from May 26, 2020 to May 26, 2021. This decision was enacted in a further regulation amending the European Medical Devices Regulation on April 23, 2020. Once again, paragraphs 3 and 4 of Article 120 were adapted. However, original changes made in the second corrigendum were unaffected by the recast of paragraphs 3 and 4.
The executed amendments in MDCG 2020-2 relate to Class I devices that were lawfully placed on the market under the old Medical Devices Directive (93/42/EEC) prior to May 26, 2021, and for which the involvement of a Notified Body in the conformity assessment procedure would be required for the first time under the MDR requirements. Accordingly, Clause 3 of Article 120 now allows an extension of the transition period until May 26, 2024, and provision of the product until May 26, 2025. This provision applies to Class 1r devices, i.e., reusable surgical instruments or devices up-classified from Class 1 (non-measuring, non-sterile) under the MDR. The condition for granting an extended transition period is that the medical device continues to meet the requirements of the MDR. The date of the declaration of conformity must be before May 26, 2021, and the notified body must also be accredited under the MDR. There must also be no significant changes to the device or its intended purpose after May 26, 2021.
However, the MDR requirements regarding post-market surveillance, market monitoring and vigilance must be implemented by May 26, 2021. For Class I devices, for example, a post-market surveillance report must be prepared. This will be prepared initially and updated as needed. Recalls must also be reported to the authorities in the case of Class I products.
Since it can be assumed that the EUDAMED database will not be fully functional by the new deadline of May 26, 2021, registrations of economic operators or products must continue to be made for Germany via DIMDI.
Manufacturers of class I products who have fallen behind with the implementation of the requirements will thus be granted more time to take care of these important issues and thus meet the EU-wide requirements. seleon GmbH will be happy to provide you with active support in this regard – whether in 2020, 2021 or beyond.
Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.
Due to the rapidly changing situation in the context of the Covid 19 pandemic, changes in legal or regulatory requirements may occur at short notice, which we are unable to reflect on a daily basis.
