MedTech Europe is the leading European association for the medical technology sector, including diagnostics, medical devices, and digital health. During the AboutMedicalDevices conference, Merlin Rietschel, Senior Manager of Medical Devices, Industrial Policies, analysed the state of the European medical devices industry through a survey conducted among medical device manufacturers, highlighting issues related to the implementation of MDR regulations.
Divergence in Certification Timelines
A significant divergence emerged regarding the timelines recorded by manufacturers compared to those reported by notified bodies for achieving MDR certification (for devices with QMS – Quality Management System certificates). The certification process takes an average of 19.5 months for both large and small-to-medium-sized manufacturers.
Rising Costs: A Burden on the Industry
Regulatory costs for MDR/IVDR certification have doubled, driven by increases in notified body fees for QMS certification and technical documentation evaluation, as well as delays in the process. In addition to these fees, manufacturers face additional costs, including:
- FTE (Full-Time Equivalent) costs to complete and maintain certification;
- Post-market surveillance (PMS) and annual vigilance expenses;
- Five-year recertification costs.
Innovation Drifting Away from Europe
Another striking finding about the current state of the industry is the geographic preference for launching innovations. Regulatory complexity is steering companies away from Europe as a launch market for innovations. Large manufacturers and SMEs have reduced their choice of Europe for initial regulatory approval by 33% and 19%, respectively, favouring markets with less stringent rules, such as the United States.
Urgent Solutions for a More Efficient System
This scenario demands swift action to counter the negative trend. MedTech Europe proposes “bridge measures” with legal weight to address the current challenges:
- Predictability in timelines and costs: simplifying the evaluation phases and technical documentation updates;
- Accelerated pathways for innovation;
- Adapting certification to follow a lifecycle-based approach (renewals).
Rietschel also emphasized the need to push for a review and subsequent adjustment of the regulatory system by:
- Implementing the objectives of MDCG 2022-14 (structured and harmonized dialogue across Europe, evidence optimization, reducing the sampling burden for technical documents, etc.);
- Enabling electronic instructions for use (e-IFU) for all medical technologies;
- Supporting global regulatory convergence, particularly through the Medical Device Single Audit Program (MDSAP).
A More Attractive Future for Innovation in Europe
To ensure Europe’s competitiveness and attractiveness for innovation in medical technologies, a reform package is urgently needed, including:
- A unified governance structure to oversee the regulatory system;
- Targeted measures to increase regulatory efficiency and incentivize innovation.
MedTech Europe’s vision for the future of the medical technology industry is detailed in the document “The Future of Europe’s Medical Technology Regulations” (available at this link here).
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Laura Legnani – Marketing Services Manager
