Elena Lucano
The European Commission's December 2025 proposal to amend the MDR and IVDR is the most significant regulatory shift since the regulations took effect. It touches certification timelines, clinical evidence requirements, Notified Body oversight, and innovation pathways. Whether you're an early-stage developer, a mid-size manufacturer navigating your first MDR submission, or a strategic managing hundreds of legacy products, these changes will reshape your compliance roadmap.
By Elena Lucano with Sara Wulff contributing.
How We Got Here: The MDR's Unintended Consequences
The EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) were designed to strengthen patient safety. Once entered into force, they did raise the bar on product safety and clinical evidence requirements. Nevertheless, the introduced regulations also initiated consequences that Europe's regulators did not anticipate—and that manufacturers have been absorbing for years.
The numbers tell the story. According to MedTech Europe's 2024 IVDR & MDR Survey Results showed that compliance costs under the MDR/IVDR have increased by up to 100% compared to the previous directives, with 90% of that spend going to personnel costs for QMS and technical documentation. The 2025 survey additionally reported that certification timelines have stretched to 13–18 months for most Notified Bodies, and nearly a third report timelines of 19–24 months for QMS-plus-product certificates. As of February 2025, only about 12,177 MDR certificates had been issued against 28,489 applications filed—a conversion rate that reflects the scale of the bottleneck.1
The impact on innovation has been measurable. The MedTech Europe’s survey also reported that since the MDR took effect, large medical device manufacturers choosing the EU as their first-launch geography dropped by 33%, with SMEs declining by 19%. For IVD manufacturers, the decline was even steeper: 40% for large companies and 12% for SMEs. Additionally, results show that nearly 29% of manufacturers producing orphan devices indicated they would transition less than 5% of their orphan product portfolios to the MDR.
In short, the MDR achieved stronger product safety but at the cost of product availability and product innovation; two variables that are essential to patient safety. The European Commission recognized this imbalance, launching a targeted evaluation in 2024 that confirmed what industry had been signaling: conformity assessment procedures are overly complex and costly, legal requirements are inconsistently applied across member states, adaptive pathways for breakthrough and orphan devices do not exist, and the regulations have had unintended negative impacts on competitiveness and patient care. 
The December 2025 EU MDR Revision Proposal: What It Covers
On December 16, 2025, the European Commission published COM(2025) 1023, a proposed regulation amending both the MDR (EU 2017/745) and the IVDR (EU 2017/746). This is not a rewrite. It is a targeted amendment across eight thematic areas, designed to streamline the regulatory framework while preserving the safety objectives that underpin it.
The proposal focuses on eight areas: simplification and proportionality, reduction of administrative burden, innovation and availability of devices, predictability and cost-efficiency of certification, coordination within the decentralized system, further digitalization, international cooperation, and interplay with other EU legislation. Below, we unpack the changes that matter most. 
Simplification and Proportionality
Several changes here will directly affect how manufacturers build and maintain their regulatory programs. The Person Responsible for Regulatory Compliance (PRRC) requirement is being relaxed: the proposal removes detailed qualification prerequisites and the requirement for permanent in-house availability, making it easier to assign a PRRC externally. Certificate validity is changing too—the fixed five-year expiration on CE certificates would be eliminated and replaced with ongoing surveillance-based validity, removing a major recurring burden.
On clinical evidence, the proposal opens the door to wider acceptance of non-clinical data to demonstrate safety and performance. A new definition of "well-established technology device" is introduced, and classification rules are being revised to potentially lower risk classes for certain device categories, including reusable surgical instruments, accessories to active implantable devices, and certain software. For manufacturers in these categories, this could mean reduced Notified Body involvement and a lighter conformity assessment pathway.
Reducing Administrative Burden
The scope of the Summary of Safety and Clinical Performance (SSCP) would be reduced, and the Notified Body's validation role on SSCPs removed. Periodic Safety Update Report frequency would decrease. Vigilance reporting timelines for certain serious incidents would be extended, giving manufacturers more time to compile thorough reports rather than rushing incomplete ones.
Notably, the proposal introduces a clear distinction between notifiable and non-notifiable changes, both for devices and QMS, and encourages manufacturers to establish formal change-control plans. For organizations managing large product portfolios, this clarity alone could meaningfully reduce the administrative overhead of post-certification change management.
Innovation and Device Availability
This is arguably the most forward-looking section of the proposal. Conditions for in-house devices manufactured and used within health institutions would become more flexible. New derogations for public health emergencies, disasters, and crises are proposed. And member states, together with the Commission, would be empowered to establish regulatory sandboxes to address the needs of emerging technologies.
For manufacturers of single-use devices, take note: the proposal would require a justification for single-use designation, with reprocessing instructions required where that justification is not provided. This revers the currently established approach that would require manufacturer of single-use devices to work on the justification.
Legacy orphan devices would receive new transitional periods (often called 'grandfathering' provisions), addressing the availability crisis that survey data has highlighted.
And then there is the Breakthrough Device (BtX) pathway—a new initiative supporting breakthrough and orphan devices through prioritized review, early structured dialogue, and expert panel engagement. The BtX designation criteria require both genuine novelty and a significant positive clinical impact for life-threatening or irreversibly debilitating conditions. The already published MDCG 2025-9 provides foundational guidance, with a pilot program anticipated for Q2 2026. We will be publishing a dedicated deep-dive article on the BtX pathway, including qualification criteria and strategic considerations for manufacturers. Stay tuned.
Predictability and Cost-Efficiency of Certification
Documented procedures for structured dialogue between manufacturers and Notified Bodies would be formalized, giving manufacturers a legal basis for early engagement. Conformity assessment procedures would see lower and remote Notified Body involvement for lower-risk devices (Class IIa and IIb for medical devices, Class B and C for IVDs), with no NB involvement at all for sterile IVD Class A devices.
For SMEs and orphan device manufacturers, the proposal introduces reduced Notified Body fee structures, with costs to be more consistently structured across Notified Bodies. This should be a welcome change given the wide variance manufacturers currently encounter. A proposed implementing act under Annex VII would introduce maximum timelines and clock-stop rules for conformity assessment. The proposal includes:
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Application review: 30 days, 1 clock-stop
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QMS assessment: 120 days, 3 clock-stops
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Technical documentation review: 90 days, 3 clock-stops
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Final decision and certificate release: 15 days, no clock-stops
In its position paper2 on the proposed new MDR/IVDR Annex VII timelines, Team-NB welcomes clearer deadlines for key certification steps as these could improve predictability and transparency. However, it is worth noting that Notified Bodies have raised concerns about the feasibility of some proposed timelines—particularly the 90-day technical documentation assessment period for complex devices—suggesting these may require adjustment during the legislative process. In the paper Notified Bodies argue the timelines are too tight and often unrealistic, especially for complex technical documentation reviews and decision-making given resource and competency constraints, and recommend longer, more consistent timelines (e.g., 150 days for documentation, 25 days for decisions with a clock-stop) to ensure quality, flexibility, and effective implementation in practice.
Coordination, Digitalization, and International Cooperation
The proposal streamlines the Notified Body designation process, reduces monitoring frequency, and removes the reassessment requirement. A dispute resolution mechanism with an ombudsperson role is introduced, and the EMA's support role in medical device regulation is formalized for the first time.
On digitalization, Declarations of Conformity, Instructions for Use, and labels may all be provided electronically. Technical documentation and conformity assessment documents may be drawn up in digital form. EUDAMED and UDI provisions are clarified, with the first four EUDAMED modules (actor registration, UDI/device registration, Notified Bodies & certificates, and market surveillance) becoming mandatory as of May 28, 2026.
A new section on international cooperation promotes activities around global regulatory convergence, including explicit references to the IMDRF and MDSAP. For manufacturers operating across both the US and EU, this signals the Commission's intent to reduce duplicative requirements over time. On interplay with other EU legislation, the proposal accepts a single submission for combined studies involving medicinal products, medical devices, and IVDs, and incorporates cybersecurity explicitly into General Safety and Performance Requirements (GSPR) and the serious incident reporting framework.
What The Proposed 2025 EU MDR Revision Means for You
If You're a Manufacturer
The cumulative impact across strategy, QMS, and technical documentation is substantial.
Strategically, you may benefit from device reclassification (particularly for software, reusable surgical instruments, and accessories to active implantable devices), the BtX and regulatory sandbox pathways, lower and more consistent Notified Body fees, and the removal of fixed certificate expiration.
On the QMS side, expect clearer rules for change management, less frequent PSURs and surveillance audits (every two years if no safety issues arise), and extended vigilance reporting timelines.
For technical documentation, the expanded definition of clinical data makes equivalence claims more accessible, non-clinical evidence carries greater weight, and electronic submission of documentation becomes formally permitted.
If You're a Health Institution
In-house device conditions become more flexible, with the ability to transfer devices outside the institution and the removal (for IVD) or extended window (for MD) for equivalent device requirements. Central laboratories manufacturing tests exclusively for clinical trials are added to the regulatory scope.
If You're a Distributor
The Notified Body certificate requirement for relabeling or repackaging activities would be removed, along with the prior notice obligation—a significant simplification of the distributor compliance pathway.
If You're a Notified Body
Notified Bodies would be required to establish documented procedures distinguishing changes manufacturers can implement without notification, without approval, or only with approval. Reduced involvement for lower-risk devices, increased use of remote audits, biannual surveillance audits (absent safety concerns), and "for-cause" unannounced audits all reshape the NB operating model.
What You Should Be Doing Now to Prepare for the Proposed EU MDR Revision
This is a proposal, not codified or enacted law. It must still pass through the European Parliament and Council before taking effect. But the direction is clear, and manufacturers who begin preparing now will have a meaningful advantage when these provisions are finalized.
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Assess how the proposal impacts your products. If your device could be reclassified under the revised rules, understand what that means for your conformity assessment pathway. If you manufacture orphan devices, evaluate the new transitional provisions.
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Prepare for EUDAMED. The first four modules become mandatory in May 2026. If your registration, UDI, and certificate data are not ready, close that gap now.
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Invest in clinical and post-market capabilities. The proposal broadens what qualifies as clinical data and elevates the value of non-clinical evidence—but that does not reduce the rigor required. PMCF planning remains essential, especially for devices that may pursue the BtX pathway.
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Build a change-control plan. The proposal explicitly encourages this. If you do not already have a documented framework for managing notifiable versus non-notifiable changes, develop one before the rules are finalized.
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Start digitalizing. Electronic Declarations of Conformity, IFUs, labels, and technical documentation are all on the table. If your QMS and technical files are still paper-based or fragmented, the transition to digital should begin now.
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Evaluate the BtX pathway. If you are developing a genuinely novel device for a life-threatening or irreversibly debilitating condition, assess your eligibility now and monitor the anticipated Q2 2026 pilot launch. Our forthcoming article covers the BtX criteria and strategic considerations in detail.
Frequently Asked Questions Regarding the Proposed 2025 EU MDR Revision
When will the proposed MDR and IVDR revisions take effect?
The European Commission published its proposal (COM(2025) 1023) in December 2025. It must still pass through the European Parliament and Council before becoming law. While no official timeline for adoption has been confirmed, the legislative process typically takes 12–24 months and once in force a transition period is provided for compliance. Manufacturers should treat the proposal's direction as a strong signal and begin preparing now rather than waiting for final adoption.
Will the MDR revision reduce clinical evidence requirements for medical devices?
Not exactly. The overall standard for demonstrating safety and performance remains. What changes is the scope of data that qualifies as clinical evidence: the proposal widens acceptance of non-clinical data and introduces a "well-established technology device" definition that may broaden equivalence pathways. For devices pursuing the Breakthrough Device (BtX) designation, some confirmatory evidence can shift into post-market follow-up—but only with a robust PMCF plan in place.
What is the EU Breakthrough Device (BtX) pathway?
BtX is a new designation under the MDR and IVDR for devices that demonstrate genuine technological novelty and a significant positive clinical impact on life-threatening or irreversibly debilitating conditions. Designated devices receive prioritized Notified Body review, early structured dialogue with expert panels, and the possibility of CE certification with post-market evidence commitments. MDCG 2025-9 provides foundational guidance, with a pilot program anticipated for Q2 2026. Read our dedicated BtX article for a full breakdown of qualification criteria and strategic implications.
Will my CE certificate still expire every five years under the revised MDR?
If the proposal is adopted as written, the fixed five-year certificate expiration would be eliminated and replaced with ongoing surveillance-based validity. Notified Bodies would still conduct biannual surveillance audits (absent safety concerns), but the formal recertification cycle would no longer apply.
How does the proposed revision affect SMEs and startup medical device companies?
The proposal includes several provisions aimed at easing the disproportionate regulatory burden on smaller manufacturers. These include reduced Notified Body fees for micro, small, and orphan device manufacturers; the BtX pathway with access to EU-level funding mechanisms like the EIC Accelerator and Horizon Europe; regulatory sandboxes for emerging technologies; more flexible PRRC requirements; and simplified conformity assessment for lower-risk device classes. Collectively, these provisions are designed to reduce the barriers that have driven many smaller companies away from the EU as a first-launch market.
What are the key MDR transition deadlines manufacturers should know?
Several critical deadlines are approaching:
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May 26, 2026: Final date for Class III custom-made implantable devices to achieve full MDR compliance, and the date the first four EUDAMED modules become mandatory
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December 31, 2027: Transition deadline for high-risk devices (Class III, implantable Class IIb)
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December 31, 2028: Deadline for remaining device classes (Class IIb non-implantable, Class IIa, sterile Class I, and Class I with measuring function)
For IVDR-specific deadlines, see our companion article on the IVDR transition timeline.
Related Reading
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Europe Just Created a Breakthrough Device Pathway: What BtX Means for Your Market Strategy — Sara Wulff examines the BtX qualification criteria, what designation gets you, and how to position for the anticipated Q2 2026 pilot. [LINK TO BtX ARTICLE WHEN PUBLISHED]
Navigate What's Next
The regulatory landscape in Europe is shifting. Manufacturers who engage early will be best positioned when these provisions take effect. Veranex's regulatory, quality, and clinical teams work across both US and EU markets, supporting medical device and IVD manufacturers from first regulatory strategy through post-market compliance. Whether you need to assess how the proposed revisions affect your product portfolio, prepare for EUDAMED, evaluate the BtX pathway, or strengthen your clinical evidence program, we can help you build the plan and execute it.
About the Author
Elena Lucano is Sr Manager of Regulatory Affairs and Quality Assurance at Veranex. An engineer by training, Elena has led regulatory and QA programs for medical devices and digital health products across the EU, US, Switzerland, and UK—from startups through large corporates—ensuring alignment with MDR, IVDR, and international regulatory frameworks. She is based in Veranex's European operations.
Sara Wulff is Director, Quality and Regulatory Affairs at Veranex.
Disclaimer: The information in this article represents Veranex's general interpretation of the regulatory framework. An individual interpretation must be made in each specific case. Each manufacturer is responsible for interpreting the requirements based on their specific device and operations.
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