MDR amendment proposal article 120 (3) oversight set to be fixed by Council

Kermit mysteryIt’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal.

Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 May 2020 in article 120 (3) of the MDR were indeed an oversight after all.

The Council’s fix

The Council has now moved swiftly and put in a proposal to fix this. Informal discussions were concluded at the Presidency and the proposal was discussed with particular attention was paid to the oversight with regard to article 120 (3) MDR. Based on these consultations, the Presidency believes now that a large majority of delegations can support the Council’s fix.

The fix containsĀ an amendment to article 1 (6) of the proposal by adding a new Article 1 (6) (aa) that moves the date of application in article 120 (3) MDR to 26 May 2021 as well:

Article 1 6) (aa)Article 120 is amended as follows:

paragraph 3 is replaced by the following:

“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, 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. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.,”

Still only a proposed amendment to a proposal, but at least the proposal as a whole is consistent now.

What’s next

Stay tuned for further developments! The Council document referenced sets out the further steps to the legislative procedure:

  1. The Permanent Representatives Committee is invited to agree on a mandate based on the Presidency text set out in Annex I at its meeting on 8 April. The mandate will then be transmitted to the European Parliament in a letter in which the Chair of the Committee informs the Parliament about the Council intention to reach an agreement at first reading.
  2. The European Parliament is expected to vote its position at first reading already at its plenary on 16 April.
  3. After the vote in the European Parliament, the Permanent Representatives Committee will be invited to examine the Parliament’s position and agree if it corresponds to the Council mandate. Should that be the case, a written procedure will be used to invite the Council:
    – to approve the Parliament’s position, and
    – to agree to derogate from the eight-week period foreseen for scrutiny by the national parliaments.
  4. Consultation of the European Economic and Social Committee and the Committee of the Regions is compulsory, as this proposal concerns public health. Both consultations must be finished before the Regulation amending Regulation (EU) 2017/745 is adopted. The Council mentions that both Committees have been contacted with the aim of speeding up the consultation.

And then the proposal is hopefully published in time. Because it can enter into force on the day of publication, hopefully that will be in time before 26 May 2020.


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