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December 19, 2025

Approximately 5 minutes

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.

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Questions & Answers (3)

A
Guest

We are currently selling a diagnostic SaMD (Software as a Medical Device) under the MDR transition period. If we migrate our hosting from a local server to an AWS/Azure cloud environment does this count as a "significant change" that would void our legacy status and force immediate MDR certification?

ElendiLabs

This depends on whether the migration affects the software's performance or intended purpose. According to MDCG 2020-3, changes to the "operating environment" are generally not considered significant if they don't alter the algorithm or user interface. However, if the cloud migration involves a change in how the software processes data or affects its cybersecurity profile, a Notified Body may deem it significant. We recommend a formal Significant Change Assessment to document why this move does not invalidate your legacy status.

A
Guest

Our company has been waiting for EUDAMED to be "fully functional" before registering our devices. With the new reform has the mandatory registration for the Actor UDI and Device modules been pushed back further?

ElendiLabs

Actually, the 2024 reform (Regulation 2024/1860) accelerates the mandatory use of certain EUDAMED modules. Instead of waiting for the entire system to be ready, the EU will make individual modules mandatory as they become functional. Actor registration, UDI/Device registration, and Certificates/Notified Body modules are expected to become mandatory as early as Q4 2025 or early 2026. Manufacturers should not wait; you should begin the registration process now to avoid a "bottleneck" once the legal mandate takes effect.

A
Guest

We have MDD-compliant stock in our warehouse manufactured before our certificate expired. Since the EU abolished the "sell-off" period can we continue to sell this stock to our distributors indefinitely?

ElendiLabs

Not necessarily. According to Regulation (EU) 2023/607, there is a critical distinction between "Placed on the Market" and "Made Available." 1. The "Placed on the Market" Hurdle: To sell your stock, it must have been "placed on the market" before your MDD certificate expired (or before the end of your specific extension period). This means you must have already transferred ownership (or have a written agreement to transfer) to a distributor or the end-user. ◦ If the devices are still in your warehouse (the manufacturer's control) and your certificate expires without a valid MDR extension, you cannot legally sell them to a distributor. They are "trapped" stock. 2. The "Made Available" (Sell-off) Freedom: If the devices were legally placed on the market (e.g., already sold to and sitting in a distributor’s warehouse) before your certificate lapsed, then yes, they can be "made available" (resold) to hospitals or patients without any regulatory cut-off date. 3. The Practical Limit (Shelf Life): While the law has no end date, the device is limited by its physical/chemical expiry date. You cannot sell an MDD-compliant device past its shelf life, and you cannot relabel it or extend the shelf life under the MDD once your certificate is gone.

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