As already reported in our blog post of 25 March 2019 (MDR – A 12-month moratorium emerges in the shadow of Covid-19), the EU Commission has now actually submitted a proposal for a moratorium on the Medical Devices Regulation (EU) 2017/745 (MDR) (cf. text of the Commission proposal and press release of the EU Commission dated 3 April 2020).
With the challenges that the COVID-19 crisis poses to the medical device industry and the health care system in the EU, the already problematic implementation of the MDR by the original deadline on 26 May 2020 has become illusory. The moratorium is to be implemented – legally and technically necessary – in the form of an amending Regulation to the MDR, although the legislation must take place in an accelerated procedure to ensure that the amending Regulation enters into force before 26 May 2020.
It is important for economic actors to know that the start of validity only for certain provisions of the MDR should be postponed, with two important structural exceptions:
- The general date of application of the MDR should be postponed by one year. The new date of application of the MDR would then be 26 May 2021.
- In contrast, the possibility of special approvals (exemptions from the conformity assessment procedures) according to Art. 59 MDR at Union level should already apply when the proposed amending Regulation enters into force. This is intended to enable the extension of national special approvals to the entire Union in the short term in order to combat the COVID-19 crisis, so that bottlenecks in important medical equipment (e.g. medical gloves, surgical mouth and nose protection or respiratory equipment) can be dealt with quickly.
- On the other hand, the Commission proposal does not provide for other transitional arrangements of importance to economic operators to be postponed accordingly for one year. In particular, the end of the so-called “grace period” for MDD certificates and Class I products classified higher under the MDR on 27 May 2024 (Art. 120 para. 2, second subparagraph, MDR) and the sales period for MDD compliant products on 26 May 2025 (Art. 120 para. 4 MDR) should not be adjusted. Manufacturers, importers and distributors should take this into account in their product planning.
Incidentally, the expected amendment regulation will also trigger legal changes at national level. In particular, the Medical Devices Law Implementation Act (MPDG), which has already been passed in Germany, must be adapted to the new legal situation regarding the MDR and the existing Medical Devices Act must be extended.
Do you have questions about this news or do you want to discuss the news with the author? Please feel free to contact us: Dr. Boris Handorn