Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions, was published in the Official Journal of the European Union on 24 April 2020. 26 May 2021 is now the official date of full application of the EU’s Medical Device Regulation (MDR).
The amendment does not alter the substance of MDR. The amendment also does “not impose new obligations on the concerned parties”. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of the MDR.
The amendment does not alter the substance of MDR. The amendment also does “not impose new obligations on the concerned parties”. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of the MDR.
Please note that the proposal ONLY covers the MDR, not the IVDR.
Amendment 2020/561 is nox integrated in the latest consolidated version of the Medical Device Regulation.
What does this mean to you?
If you are a Medical Device manufacturer, we strongly advise you to continue working on your transition plans for the MDR. This amendment offers you one additional year to successful transition.
In practice, the Date of Application of the MDR has now changed from May 26, 2020 to May 26, 2021.
This means that all devices will have to comply to the MDR by May 26, 2021.
A device which is a class I device as per Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to the new date of application, 26 May 2021, and for which the MDR conformity assessment procedure requires the involvement of a notified body, may be placed on the market or put into service until 26 May 2024 (date unchanged), provided that from 26 May 2021, it continues to comply with Directive 93/42/EEC, and provided there are no significant changes in the design and intended purpose.
A device which has a valid certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, may be placed on the market or put into service until the expiry date of the certificate but no later than 26 May 2024 (date unchanged), provided that from 26 May 2021, it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose.
For the aforementioned devices, the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in the Directives, as of the new date of application, 26 May 2021.
Thus, the devices that gain the most from this one-year delay are class I devices that are not up classified under the MDR and Annex XVI devices.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
