MedTech Europe 2024 Regulatory Survey: key findings and insights
MedTech Europe shares the results of its 2024 Regulatory Survey, highlighting challenges manufacturers face with the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). The findings reveal increasing concerns around costs, timelines, and regulatory predictability.
Key findings:
- Shift in manufacturer concerns: While finding a Notified Body is less of an issue, uncertainty around costs, timelines, and predictability remains, risking Europe’s attractiveness for innovative devices.
- Conformity Assessment Efficiency should be improved: Over 50% of conformity assessment time is spent outside the review phase. Streamlining pre-review and certificate issuance could reduce total assessment time.
- Increased costs for manufacturers: Rising costs in clinical evaluations, Post-Market Surveillance (PMS), and certification are challenging manufacturers, with variability across Notified Bodies complicating financial planning.
- Long-Term financial strain: By the end of a five-year certification cycle, IVD manufacturers will spend 70% more on maintenance and re-certification, while MD manufacturers face a 50% increase.
These findings underscore the need for reform in predictability, transparency, and cost-efficiency to enhance Europe’s competitiveness and strengthen its global role in healthcare. MedTech Europe is committed to collaborating with stakeholders to drive improvements benefiting manufacturers, patients, and the healthcare sector.
Discover the full IVDR and MDR survey results below.
Posted on 15.01.2025