On December 16, 2025, the European Commission adopted a new proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The proposal aims to streamline the regulatory landscape for medical devices in the EU is expected to transition from a phase of implementation challenges to a more structural, streamlined, and digitalized framework.
1. Reduced Operational Costs and Administrative Burden The future regulatory environment aims to significantly lower compliance costs, with estimated savings of over €3 billion per year for the sector.
• End of Recertification Cycles: The structural removal of the maximum 5-year validity period for certificates means manufacturers will no longer face the burden of repetitive recertification. Instead, Notified Bodies will conduct periodic surveillance reviews proportionate to the risk,.
• Simplified Procedures: For certain lower and medium-risk devices (Class IIa, non-implantable Class IIb), Notified Body involvement will be reduced, requiring technical documentation assessment only for representative devices rather than every device,.
2. Accelerated Access for Innovation The EU market is set to become more attractive for new technologies through specific, fast-track pathways:
• Priority Pathways: New definitions for “Breakthrough Devices” and “Orphan Devices” (for small patient populations) will allow for priority access and “rolling reviews” by Notified Bodies, reducing time-to-market,.
• Regulatory Sandboxes: To foster innovation in emerging fields (such as AI), the proposal introduces “Regulatory Sandboxes,” allowing manufacturers to test innovative technologies under supervision before full conformity assessment,,.
3. Protection of SMEs Recognizing that 90% of the sector consists of SMEs, the future outlook includes specific safeguards to maintain their competitiveness:
• Mandatory Fee Reductions: Notified Bodies will be required to offer reduced fees for micro and small enterprises, as well as for orphan devices,.
• Flexible Staffing: The requirement for the Person Responsible for Regulatory Compliance (PRRC) will be relaxed for small companies; the PRRC will no longer need to be “permanently and continuously” at the disposal of the organization, merely “available”,.
4. Digitalization and “Paperless” Compliance The sector will move toward a digital-first approach to documentation:
• Digital Documentation: Manufacturers will be allowed to provide technical documentation, declarations of conformity, and reports in digital formats,.
• e-IFUs: The use of electronic Instructions for Use (e-IFU) will be expanded, including for near-patient tests, reducing paper waste and logistical costs,.
5. Centralized Governance and Supply Security To prevent future crises, the system will rely on stronger central coordination:
• Shortage Monitoring: Manufacturers will be obliged to report anticipated supply interruptions six months in advance.
• EMA Role: The European Medicines Agency (EMA) will take on a reinforced role, providing administrative and technical support to expert panels and facilitating coordination among national authorities to ensure harmonized implementation,.
Projected Timeline The proposal is expected to be adopted by the European Parliament and Council by the second quarter of 2027. Following its entry into force, a comprehensive evaluation of these new measures is scheduled after five years to ensure they are meeting the objectives of patient safety and market efficiency.
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