MedTech Europe post-EPSCO meeting statement on MDR/IVDR reforms

Following the EPSCO meeting on 3 December 2024 at which the subject of MDR/IVDR reform was discussed, MedTech Europe has published its response to the out come of the meeting, available from here.

In the statement, the industry association comments:

“[W]e call for the swift adoption of immediate measures, and before the targeted evaluation’s conclusions. Europe’s healthcare systems cannot wait years for reform packages to be debated and enacted. Urgent measures are needed now to address devices availability, the delays in certification, regulatory bottlenecks, and disproportionate burdens on small- and medium-sized enterprises (SMEs), which threaten innovation and access to medical technologies in Europe.”

The statement continues, mirroring many of the comments made at the EPSCO meeting:

“We urge the European Commission and Member States to act swiftly, and implement solutions with sufficient legal weight to:
• Significantly reduce certification time and costs.
• Streamline assessment processes for device updates and innovations.
• Create an accelerated pathway for breakthrough technologies.
• Remove the limited validity of certificates and adopt a lifecycle approach.
• Deliver on the goals of MDCG 2022-14 (structured dialogue, leveraging evidence, reduce technical documentation sampling burden…)
• Promote digital solutions like electronic Instructions for Use (eIFU).
• Support global regulatory convergence, such as through the Medical Device Single Audit Program (MDSAP)”

The only point of potential disagreement is with regard to the proposal made to EPSCO for the European Medicines Agency (EMA) to take over governance of the IVDR and MDR, about which MedTech Europe comments:

“Should this role be given to the European Medicines Agency (EMA), it would be important to maintain the specificity of the medical technology sector alongside keeping the Notified Body-based system.”

Industry waits to learn of next steps.