Long before the Corona crisis, strong voices were heard calling for an adjustment or at least a postponement of the MDR. In particular, the demands on medical device manufacturers and the associated certification effort were disproportionately high. For digital health applications, which in themselves also constitute medical devices and thus fall within the scope of the MDR, this criticism accumulated in particular to Annex VIII, Rule 11 MDR, which has been discussed elsewhere.
The EU Commission has now published a proposal for the postponement of the MDR on Friday, April 3rd. The European Parliament and the European Council will now agree on this draft in order to formulate a decision which can then be adopted by the Parliament.
If the MDR is postponed, the MDD will continue to apply accordingly. Certification according to the MDD generally means a lower risk class for medical software and thus a lower certification effort. MDD certification also makes Art. 120 para. 3 MDR attractive. This states that MDD-certified products may remain in circulation after the MDR becomes effective, at least until 26 May 2024 or as long as they do not undergo any changes in the product or its intended use. Many manufacturers are already taking up this option and are aiming for short-term MDD certification. The QuR.digital GmbH will be happy to accompany you in this process!
It is now questionable whether the transitional regulation for MDD-certified products will also be extended in the course of the MDR amendment and thus affect all products that will be MDD-certified accordingly by 26 May 2021. Unfortunately, the proposal leaves an ambiguity here, which may be unintentional. This is because the transitional regulation now no longer refers abstractly to the “period of validity” of the MDD, but explicitly to the period up to May 26th 2020, i.e. the originally planned date of commencement of the MDR. This previously intended date for the start of MDR’s validity was only just inserted by Corrigendum II to MDR. If one now takes the proposal literally, then only those products are affected by the exemption that have been certified according to MDD by 26 May 2020, although the MDD is still valid after that date and the MDR only from 2021. It may be that the EU Commission actually wants to introduce a cut here and does not want to extend the MDD indirectly beyond 26 May 2020. However, it must rather be assumed that the changes made by the 2nd corrigendum have simply been overlooked. These are even on the official site www.eur-lex.europa.eu not incorporated into the MDR version to be found there and can therefore easily be overlooked.
It is to be expected that this lapse should be corrected in the further course of the MDR amendment and that manufacturers will thus be given until 26 May 2021 to certify their products according to the MDD and thus also remain EU-compliant until 2024.
In a paper of the European Council of April 8th 2020, the proposal of the EU Commission has now been adapted accordingly, also with regard to the transitional regime anchored in Art. 120 para. 3 of the MDR, and the date of application has been postponed by one year to 26 May 2021. However, the transition period will be shortened from four to three years in total. The amended draft is expected to be voted on by the European Parliament as early as 17 April 2020.
The EU Parliament, has approved the postponement of the MDR almost unanimously on 17.04.2020. The postponement will become official and thus binding as soon as the amendment has been published in the Official Journal of the European Union.