EU-MDR amendment proposal: the next steps

The European Council has published its position on ‘The Proposal’ to postpone the Regulation (EU) 2017/745 (#MDR) dates of application by one year. 

At the same time, the Council ‘rectifies’ the oversight in the Commission’s proposal with respect to article 120 (3) (the initial document did not move the date and raised more questions than it answered for up-classified class I devices)

So, what is to expect from now on? Not what you would call a fast-track process. But surely one that will automatically enter into force once published. Hopefully before May 26th, 2020!

1. The Permanent Representatives Committee has been invited by the Council's position to agree on a mandate based on the Presidency text published on April 7th.

2. This mandate will be forwarded to the European Parliament and the Chair of the Committee will inform the Parliament about the Council’s intention to reach a consensus at first reading.

3. The European Parliament will then be expected to vote its position at first reading during its plenary set for April 16th.

4. Following the vote, the Permanent Representatives Committee will be asked to go through the Parliament’s position and state if it corresponds to the Council mandate. If this is affirmative, the Council will be invited to approve the Parliament’s position and to agree to ‘override’ the 8-week scrutiny period foreseen by the national parliaments.

Of note here, that on top of the above and since the ‘Proposal’ concerns a public health issue, consultations of both the EESC Committee and Committee of the Regions are compulsory and expected to be completed before the ‘Proposal’ has been adopted. 

Hard to believe that there have been no mutual agreements to either facilitate and/or expedite the process but still, the actual -bureaucratic- steps to follow are here to guide us through the weeks to come!

#evnia #evniadk #askevnia #medicaldevices #MedTech #MDR #regulatorycompliance