Navigating the Future of Medical Devices: A Deep Dive into the European Commission’s MDR Revision and Industry Proposals for a More Efficient and Innovative Landscape
The European Commission has officially announced the launch of the Medical Device Regulation (MDR) revision, a welcome development for the industry. This initiative, communicated by European Commissioner for Health, Olivér Várhelyi, on July 2nd, aims to simplify and optimize the European regulatory framework without compromising the currently guaranteed high standards of safety and efficacy. The strategic objective is to enhance the sector’s competitiveness, support technological innovation, and ensure that Europe remains an attractive market for the development and certification of medical devices.
Timeline and Next Steps for the Revision
The roadmap leading to the legislative text revisions will proceed as follows:
- Summer 2025: The European Commission will commence drafting legislative proposals.
- Autumn 2025: A formal consultation with stakeholders will ensue through the Medical Device Coordination Group (MDCG).
- December 9, 2025: The results of the Targeted Evaluation will be published at the Medical Device Conference.
- By the end of December 2025: The official proposal for the revision of the Medical Device Regulation (MDR) is expected.
- Between 2026 and 2027: The co-decision legislative process, involving the European Parliament and the Council, is projected to last 18 to 24 months or potentially longer.
Confindustria Dispositivi Medici’s Key Proposals
Confindustria Dispositivi Medici welcomes the Commission’s announcement, emphasizing the urgency of immediate interventions without waiting for the conclusion of the entire legislative process. The association has already actively contributed to the Targeted Evaluation with concrete proposals, also presented during the “Together for a Healthier Europe” event at the European Parliament.
Specifically, Confindustria Dispositivi Medici highlights four key priorities for intervention concerning the Medical Device Regulation (MDR):
1. Enhanced Efficiency and Predictable Certification Timelines
Manufacturers require clear visibility on the time needed to obtain CE certification to optimize their planning. It is also crucial to have insight into the progress of conformity assessment by Notified Bodies.
To improve the process, the following are proposed:
- Introduction of a “Clock Stop” Model: This model allows for a temporary pause in the time count when the dossier is awaiting additional information from the manufacturer. This system isolates the actual time the Notified Body is actively working on the assessment, making the process more transparent and manageable.
- Limiting Technical Documentation Review to Three Cycles: To prevent endless iterations, it is recommended to limit the technical documentation assessment to three review cycles.
- Urgent Adoption of a European Implementing Act: This act would define standard certification times, providing concrete benefits even before the complete regulatory revision.
2. Clearer Rules for Device and Documentation Modifications
Currently, the MDR does not precisely define what constitutes a “substantial modification” to a device or a quality management system. This creates confusion, slows down processes, and increases costs for companies.
Simpler and more uniform rules are needed: guidelines that clearly indicate which modifications must be communicated to Notified Bodies and which do not, with practical examples and clear timelines for evaluation. This would assist manufacturers in better managing updates without risking certification delays.
3. Simplified Regulatory Pathway for Innovative Device Market Entry
To foster innovation, it is essential to establish specific regulatory pathways for the most advanced medical devices, especially those designed for severe diseases or conditions without effective treatments.
These dedicated channels would allow for faster approval times, supporting the development of new technological solutions. In some cases, conditional certification could also be introduced, permitting the device to be placed on the market before the completion of all post-market activities, provided that specific, timely verifications are included during subsequent monitoring.
4. Adapting Certificate Validity to Device Lifecycle
The 5-year validity of CE certificates mandated by the MDR should be re-evaluated: annual surveillance audits already ensure compliance with requirements over time. Eliminating the mandatory renewal every five years would allow Notified Bodies to concentrate on more critical devices. This necessitates a legislative amendment to Article 56(2) of the MDR.
Furthermore, a short-term implementing act is needed to establish clearer and more predictable evaluation times, without having to wait for the entire regulatory revision.
Among other proposals: reducing the bureaucratic burden related to technical documentation (such as PSURs, PMS reports, and SS(C)Ps), limiting their updates only when the risk-benefit ratio significantly changes. Additionally, a risk-based approach for dossier sampling is suggested, particularly for low-risk devices, to avoid unnecessary reviews.
MDR: Lengthy Timelines and Obstacles for Businesses, Especially SMEs
The implementation of the MDR has made processes more complex and costly, particularly for small and medium-sized enterprises. This has slowed down the introduction of new devices and hindered innovation.
According to a survey by Confindustria Dispositivi Medici, 52% of companies take 13 to 18 months to obtain certification, while another 22% take up to 24 months. These delays are creating difficulties for the entire European medtech sector and limiting patient access to fundamental technologies for their care.
A Future for Innovation and Safety
Reforming the Medical Device Regulation (MDR) is essential to reduce bureaucracy, expedite processes, and support innovation, without compromising safety standards. Only then can Europe remain a global benchmark in medical technology.
We are already prepared. We are medical device manufacturers with strong and up-to-date internal regulatory expertise. Since May 2024, we have initiated the MDR transition for our entire product range:
- CE certificate extended until 2027 for Class I and IIa/IIb devices;
- CE certificate extended until 2028 for Class III devices;
- Several devices have already obtained MDR certification.
Do you want to offer MDR-compliant medical devices without having to navigate the complexity of the regulatory process?
Rely on us: We provide our expertise and a complete range of medical devices already MDR certified or with CE certificates extended until 2027 or 2028, depending on the class. Available in private label or as finished products, our devices are ready for the European market.
Contact us to discover how we can support your business.
