Political groups in the European Parliament are divided over the future of the Medical Devices Regulation (MDR) following the news that it could be up for revision, with consultations set to be launched by the end of the year.

On Wednesday (9 October) evening, political groups debated the matter after the European Commissioner for Values and Transparency, Věra Jourová, standing in for Health Commissioner Stella Kyriakides, opened the door to a revision.

“We are now collecting the necessary data in a transparent and inclusive way and expect to open a call for evidence and public consultation by the end of this year,” Jourová said.

She continued that an evaluation would assess how the regulations affect the sector’s competitiveness and the availability of medical devices in the EU, particularly for orphan and innovative devices.

This upcoming consultation will allow the Commission to assess the sentiments of sector stakeholders before drafting its future legislative proposal, as requested by some members of the right.

For example, devices considered to pose a high risk to individuals enjoy a transitional period lasting until December 2027, while those representing a low risk have until December 2029.

The news was well received by the centre-right EPP, but they expect the Commission to move faster. “The wording in the mission letter is too vague. Rumours that the Commission will not present a proposal until 2026 infuriate me,” said Peter Liese (EPP).

The German MEP also called for reducing the “bureaucratic jungle,” a sentiment welcomed by conservatives.

Ruggero Razza (Italy, ECR) similarly emphasised the need to revise the current legislation.

“To bring about change, it is not enough to simply change things; we must also look at how they are implemented,” said Andreas Glück (Renew Europe).

The centrist MEP nevertheless called for an “urgent adaptation” of the regulation, “particularly in the field of paediatric surgery, especially regarding certification timelines.”

On the left, neither a revision nor further extensions

On the other hand, some emphasised the Commission’s role in supporting member states responsible for implementing the regulation.

Rather than calling for another revision, Lithuanian MEP and former Health Commissioner Vytenis Andriukaitis (S&D) argued that the transition period, set until 2027, is “long enough” and that there “shouldn’t be any further delays.”

The Socialist group also found common ground with the Greens/EFA and The Left group. Tilly Metz (Greens/EFA), a Luxembourg MEP, emphasised that “there should be no rush to revise such an important piece of legislation.”

She reminded the Parliament that implementation deadlines have already been extended four times and that “it is up to the Commission to conduct an independent inquiry, not just industry.”

“Safety and transparency must not be compromised in the name of competitiveness and deregulation,” she concluded.

[Edited by Alice Taylor-Braçe]

Source: Euractiv.com