Pharma industry wants streamlined EU medical device rules

The Commission’s consultation on medical device safety and efficiency ended today, with the industry calling for better alignment between EU regulations and fewer overlaps.

Health Commissioner Oliver Varhelyi confirmed yesterday that the regulations on medical devices (MDR) and in vitro diagnostics (IVDR) will be revised by the end of the year.

The consultation drew nearly 500 contributions from industry players, along with patient associations and federations. 

Among them, pharmaceutical giant Takeda emphasised the need to align MDR/IVDR with the EU’s digital frameworks, pharmaceutical regulations, and clinical trial regulations.

To this end, Takeda creating a single governance structure to improve “coordination between MDR/IVDR and other regulations affecting the industry.”

Similarly, the Swiss pharmaceutical company Roche called for an impact assessment to evaluate the MDR/IVDR’s coherence with other EU legislation.

MedTech, representing the medical technology sector, warned that the fragmented system delays CE marking and hurts the sector’s competitiveness in Europe.

It also asked for better alignment between the European Medicines Agency (EMA), National Competent Authorities (NCAs), and Notified Bodies, citing “contradictory responses.”

Clarification is also needed on product lifecycle rules and Article 16 of the MDR, which covers reconditioning or relabelling devices when combined with pharmaceuticals.

“Neither the EMA guidelines nor the Medical Device Coordination Group 2021-26 guidance specifically address the situation of pharmaceutical companies, which typically acquire CE-marked medical devices in bulk from the legal manufacturer,” MedTech said.

Meanwhile, for patients, the MDR should have “clear reporting pathways” for feedback and a backup plan for shortages to avoid months or even years of physical pain, said the European Patient’s Forum.

From the hospital side, medical workers from Oslo University Hospital stated that the MDR could increase the prices of medical devices without guaranteeing better quality.

According to the European University Hospital Alliance, the MDR caused “critical delays in certification, leading to shortages and reduced variety of devices, especially in academic hospitals treating rare diseases.”

Finally, Health Care Without Harm Europe urged clearer definitions for single-use devices, commitments to phase out toxic materials, and more incentives to reuse certain medical devices.

[MM]