Invited on Wednesday 27 October to react to the postponement of the implementation of Regulation 2017/746 on in vitro diagnostic medical devices (see EUROPE 12813/13), the European Parliament’s political groups did not hide their disappointment and annoyance.
This postponement was proposed in mid-October by the European Commission, in view of the lack of “notified bodies” available to assess the conformity of devices under the new regulation.
The previous regulation (98/79/EC) meant that only a limited number of devices (about 8%) were subject to inspection by notified bodies. Under the new Regulation, however, approximately 80% of in vitro diagnostic medical devices will have to be subject to this control.
This new feature should have come into force for a series of devices from 26 May. However, at this stage, only six bodies in three EU countries have the capacity to carry out the required checks.
The representatives of the political groups all agreed that the situation required flexibility. However, they regretted that the Commission used the health crisis argument to justify this postponement.
Lack of anticipation
“Some issues should have been settled by the Commission and the Member States beforehand”, said EPP coordinator Peter Liese (Germany).
Already in 2017, the recitals of the new regulation called for precautions to be taken to avoid such shortages.
The Covid-19 pandemic “cannot be used as a permanent excuse to delay the implementation of higher safety standards”, added Tilly Metz (Luxembourg), for the Greens/EFA. Stakeholders, she recalled, have had five years to transpose the regulation.
“The first proposal for a new regulation was unveiled in 2012. With this proposed postponement, the new rules for devices in the highest risk class (D) will only come into force in 2025. That is 13 years later. I think we all agree that this undermines confidence in the European Union”, insisted Biljana Borzan (S&D, Croatia).
On behalf of The Left, Kateřina Konečná (Czech Republic), for her part, regretted that the Commission had proposed untenable initial deadlines. Finally, Renew Europe’s coordinator, Andreas Glück (Germany), stressed the need to focus on the severe lack of notified bodies. “We must make this a priority”, he said.
Continuation of the procedure
Asked what the European Commission is doing to address this shortcoming, Anna Eva Ampelas, head of the Commission’s medical products unit, said this was a sensitive issue, as the organisations are private entities, completely independent of the Commission.
However, she said that a discussion on the subject would be held with the Member States before Christmas to assess the means to be implemented.
On the new dates of application of the regulation, the final say rests with the co-legislators.
The EPP coordinator said he was ready to support the proposal for a postponement as it stands, via an urgent procedure. Most of the other rapporteurs called for more in-depth discussions.
The subject was therefore put on the table at the coordinators’ meeting, which was held behind closed doors on Wednesday. According to information obtained by EUROPE, the different groups have agreed to act quickly, but will still have to decide whether they want to use an urgent procedure - and thus support the text as it stands - or a simplified procedure that would allow for amendments.
This decision should be taken before the next coordinators’ meeting, probably in mid-November. It will also depend on the Council’s position on the matter.
See the proposal under discussion: https://bit.ly/2Xf9Nda (Original version in French by Agathe Cherki)