On Wednesday 25 January, the Member States’ ambassadors to the European Union agreed to the European Commission’s proposal to amend the medical devices and implantable devices Regulations.
Following an announcement at the Health Ministers’ meeting on 9 December (see EUROPE 13081/30), the European Commission had proposed on 6 January several regulatory measures (see EUROPE 13094/1) to avoid shortages of devices during the transition period to the new legislation (i.e. Regulations EU/2017/745 and EU/2017/746).
During the discussion in the working group on ‘Pharmaceutical and Medical Devices’ on 17 January, the delegations did not wish to make any changes to the text. The Netherlands and Denmark had entered a parliamentary scrutiny reservation.
The ambassadors therefore endorsed the Commission’s original text. The reference to the principles of proportionality and subsidiarity, whose absence had been pointed out by the Legal Service, will be added to the final text.
The text will form the basis of the EU Council’s negotiating mandate with the European Parliament.
The EU Council plans to analyse the final compromise text at the ambassadors’ meeting on Wednesday 1 February and does not foresee interinstitutional negotiations (trilogue).
The implementation of the new legislation is one of the priorities of the Swedish Presidency of the EU Council (see EUROPE 13092/2).
Link to the text: https://aeur.eu/f/52y (Original version in French by Émilie Vanderhulst)