The European Commission released a proposal on April 3rd, that would defer by one year the application of certain provisions of the MDR Regulation (EU) 2017/745, that would otherwise start to apply from 26 May 2020. This is only a proposal, and the European Parliament is expected to vote its position at first reading already at its plenary on 16 April.
The year-long delay will not alter the substance of MDR. The delay also will “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 that Regulation.
The amendment has three objectives:
- deferring application of certain provisions of the MDR that would otherwise start to apply from 26 May 2020;
- to adapt certain transitional provisions of the MDR that would otherwise no longer apply as from the date of application of those provisions; and
- to give Commission the possibility to apply article 59 of the MDR before the date of application (26 May 2021) so it can adopt EU-wide derogations in response to national derogations in order to address potential Union wide device shortages of vitally important medical devices.
Please note that the proposal ONLY covers the MDR, not the IVDR.
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, even if this proposal would be implemented. It will potentially give one additional year to successful transition.
In practice, if the proposal is implemented, the Date of Application of the MDR will change from May 26, 2020 to May 26, 2021.
This change would mean 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 will 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.