The EU MDR and IVDR Reform: A Landmark Proposal for a Framework

The EU MDR and IVDR Reform: A Landmark Proposal for a More Efficient Framework

The European Commission has officially published a proposal to reform the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). With over 200 pages across the main act and two annexes, this reform signals a strategic shift toward a more predictable and less bureaucratic regulatory environment.

Strategic Structural Changes

The proposal introduces several high-level concepts designed to foster innovation and streamline market access:

• Breakthrough Devices: A new category for innovative products, potentially offering expedited pathways for devices that address unmet medical needs.
• Removal of 5-Year Expiry: Certificates may no longer be bound to a rigid 5-year recertification cycle, significantly reducing the administrative burden on both manufacturers and Notified Bodies.
• Predetermined Change Control Plans (PCCP): Notified Bodies and manufacturers can now agree on plans that define which changes can be implemented without prior notification or approval.

Operational Efficiency and Flexibility

The reform addresses several pain points identified by the industry since the original regulations came into force:

• PRRC Flexibility: For SMEs, the Person Responsible for Regulatory Compliance (PRRC) no longer needs to be "permanently and continuously" available—only "available." Detailed qualification requirements have also been simplified.
• Vigilance Timelines: The reporting window for serious incidents (not involving immediate public health threats or death) has been extended from 15 days to 30 days.
• PSUR Updates: Periodic Safety Update Report (PSUR) frequencies are being adjusted; for Class IIa devices, updates will now only be required "when necessary."
• Sampling Improvements: Notified Bodies will see improved procedures for technical file assessment sampling, aiming for more consistent review outcomes.

Technical Definitions and Integration

The wording of technical requirements is seeing subtle but high-impact changes:

• Clinical and Biological Definitions: The addition of "same or similar" terminology for biological and clinical evaluations will impact how manufacturers justify equivalence and biocompatibility.
• CER/PMCF Integration: Post-Market Clinical Follow-up (PMCF) reporting will be directly integrated into the Clinical Evaluation Report (CER), streamlining the technical documentation structure.
• Digitalization: New Articles 48b and 52b focus specifically on the digitalization of regulatory processes.

Reclassification and Risk Profiles

Interestingly, some classification rules are being adapted to reflect a more nuanced understanding of risk. This may result in lower risk classes for specific categories, such as:

1. Reusable surgical instruments.
2. Accessories to active implantable devices.
3. Certain types of software.

Conclusion

This proposal represents a major pivot in European medical device policy. By addressing the bottlenecks in the certification cycle and introducing more flexible compliance mechanisms, the EU Commission aims to ensure that the regulatory framework supports—rather than hinders—patient access to safe and innovative technologies. Manufacturers should begin reviewing the 200+ pages of the proposal to assess the long-term impact on their product portfolios.