MedTech Europe urges the European Commission to adopt four targeted corrective measures to preserve access to thousands of medical devices in the EU. Proposals include extending transition periods, streamlining conformity assessment, and supporting innovative low-volume devices.

Amid unresolved challenges in certifying medical devices under the MDR and IVDR, MedTech Europe – the continent’s leading industry association – has presented concrete proposals to mitigate the impact of the regulatory overhaul. The four suggested reforms aim to boost device availability, improve conformity assessment efficiency, and preserve European innovation.

Major challenges under MDR/IVDR

  • Overburdened notified bodies.
  • Staffing shortages and long assessment delays.
  • Regulatory, not clinical withdrawal of many low-volume products.
  • Pressure on SMEs struggling with re-certification costs.

Four intervention pillars proposed by MedTech Europe

  1. Proportionate requirements for legacy devices – Continue market availability with enhanced PMS and risk assessment, avoiding full MDR/IVDR reassessment.
  2. Extended transition periods for low-to-medium risk devices – Class IIa/IIb until 2028; IVDs under 2024/1860 transition regulation.
  3. Increased notified body capacity – Simplify designation processes, allow modular conformity assessments, strengthen oversight without bureaucracy.
  4. Support for low-volume and high-social-impact products – Pediatric, orphan, and innovative devices to benefit from financial support and tailored clinical pathways.

Risks of inaction

MedTech Europe estimates that over 17,000 devices could be withdrawn from the EU market within 24 months. Up to 50% of SMEs may exit product categories due to compliance costs. In 2024, over 30% of Class IIa devices were uncertified, threatening availability in hospitals.

Manufacturer recommendations

  • Monitor legislative developments and engage in public consultations.
  • Diversify regulatory strategies by targeting third-country markets where EU certificates remain valid despite internal delays.

Źródło: MedTech Europe – leaflet PDF