MDR/IVDR 2.0: What the EU Commission's December 2025 Reform Proposal Means for MedTech SMEs

On December 16, 2025, the European Commission published COM(2025) 1023, a comprehensive legislative proposal to reform both the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). After years of implementation challenges, certification bottlenecks, and growing pressure on small and medium-sized enterprises, the Commission has acknowledged what the industry has been saying for some time: the current framework needs structural simplification.

This article breaks down the key proposed changes and what they mean for MedTech SMEs navigating MDR/IVDR compliance today.

Why This Reform? The Problem in Numbers

The Commission's own impact assessment is clear: the structural deficiencies of the current MDR/IVDR framework have led to certification bottlenecks, reduced availability of medical devices for patients, and unsustainable pressure on SMEs. Notified Body capacity remains limited, with average MDR certification reviews taking 13 to 18 months, and longer for complex devices. For a small manufacturer, submitting technical documentation just one year before a deadline means risking loss of EU market access.

According to MedTech Europe, these issues are not theoretical. Products have seen reduced availability on the EU market not because they were unsafe, but because the regulatory pathway was too slow, too expensive, or too unpredictable for smaller companies to sustain. The reform proposal is the Commission's direct response.

The Six Changes That Matter Most for SMEs

1. Software Reclassification Under Rule 11

One of the most impactful changes for SaMD (Software as a Medical Device) manufacturers: the proposal amends Rule 11 of MDR Annex VIII to allow a broader range of medical device software to qualify as Class I. Under the current framework, many software products are classified in higher risk categories regardless of their actual clinical impact. The reform aims to align classification with real risk, which could mean that certain SaMD products would no longer require a Notified Body assessment, significantly reducing both cost and time to market.

For SMEs developing clinical decision support tools, monitoring applications, or low-risk diagnostic software, this change could be transformative. If your product is currently classified as Class IIa or IIb solely because of Rule 11's broad sweep, the reform may reclassify it to Class I. CertHub's AI Conformity & Gap Checker can help you assess how proposed classification changes may affect your device's regulatory pathway.

2. No More Five-Year Certificate Expiry

The proposal eliminates the automatic five-year validity cap on Notified Body certificates. Instead, certificates would remain valid indefinitely, with expiry applied only where a Notified Body identifies a justified, risk-based reason to limit validity. Surveillance audits would shift to once every two years, with remote audits permitted as an alternative to on-site inspections.

For SMEs, this addresses one of the most resource-intensive aspects of MDR compliance: the re-certification cycle. Under the current system, companies must effectively re-submit their entire technical documentation every five years, regardless of whether anything has changed. The new approach ties regulatory effort to actual risk, not arbitrary timelines.

3. Standardized Notified Body Timelines

On December 12, 2025, the Commission also published a draft Implementing Regulation proposing EU-wide maximum timelines for Notified Body procedures:

Procedure	Proposed Maximum Timeline
Application review.	30 days
QMS audit.	120 days
Product verification.	90 days
Certificate issuance.	15 days
Recertification review.	60 days
Recertified certificate issuance.	15 days

These timelines, if adopted, would bring unprecedented predictability to the certification process. For SMEs planning product launches or investor milestones, predictable timelines are not a luxury, they are a business necessity.

4. Simpler Clinical Evidence and Equivalence

The reform broadens acceptable evidence sources for clinical evaluation. Non-peer-reviewed scientific literature is now proposed as acceptable clinical data. Bench testing, in silico testing, and computational modeling receive enhanced acceptance. Critically, the equivalence pathway for Class IIb and III devices is simplified: manufacturers could rely on existing clinical data, including published literature and peer device data, with a more flexible approach to accessing equivalent device data.

This would ease one of the most significant barriers SMEs have faced under the current MDR, where demonstrating equivalence has been particularly challenging for companies without established industry partnerships. CertHub's 1-Click Documentation system can generate clinical evaluation reports structured to leverage these broader evidence requirements, saving weeks of manual work.

5. New Pathways for Orphan and Breakthrough Devices

The proposal introduces dedicated regulatory pathways for orphan medical devices (addressing rare conditions) and breakthrough technologies. These pathways include priority and rolling reviews, expert panel input, and the possibility for Notified Bodies to issue certificates based on reduced pre-market data, supported by mandatory post-market evidence generation. For innovative SMEs developing first-of-a-kind solutions, this means a realistic path to EU market access without the full upfront clinical data burden.

6. Regulatory Sandboxes and AI Device Simplification

EU-level regulatory sandboxes would be established to support evidence generation for innovative technologies, including AI-driven and adaptive systems, by allowing controlled testing under regulatory oversight. Additionally, the proposal states that AI medical devices classified as high-risk under the AI Act would not need to comply with the AI Act in addition to the MDR or IVDR, a significant simplification that eliminates the dual compliance burden many manufacturers were preparing for.

This is directly relevant for any SME developing AI-enabled medical software. Instead of navigating two parallel regulatory frameworks, the reform envisions a single, integrated conformity assessment. CertHub's platform already supports AI Act and MDR cross-referencing, helping manufacturers understand which requirements apply to their specific product.

Additional Changes Worth Tracking

Expanded eIFU scope: Electronic Instructions for Use extend to professional-use IVDs for near-patient testing. MDSAP participation: The EU would participate in the Medical Device Single Audit Program, reducing audit duplication for manufacturers selling in multiple jurisdictions. In-house device flexibility: Article 5(5) MDR would be amended to permit transfer of in-house devices between EU health institutions, removing the requirement that no equivalent CE-marked device exists. Post-market reporting: PSUR frequency reduced to once in the first year, then every two years.

What Happens Next? The Legislative Timeline

The proposal (COM(2025) 1023) has entered the EU legislative process. It will now be considered by the European Parliament and the Council. The Commission has expressed its hope for adoption by the co-legislators by Q2 2027. Trilogue negotiations are expected to commence mid-2026. It is important to note that the details may be amended during the legislative procedure, what is proposed now is not yet law.

In the meantime, the current MDR and IVDR remain fully in force. Manufacturers should not delay compliance efforts based on proposed changes that may take 18+ months to become law. The smart approach is to comply with today's requirements while structuring documentation and processes in a way that can adapt when the reform takes effect.

How to Prepare: Practical Steps for SMEs

Audit your current device classification. If your SaMD product is classified under Rule 11 as Class IIa or higher, document why. If the reform reclassifies it to Class I, you will need to demonstrate that your product falls within the new scope. Review your re-certification timeline. If your certificate expires before the reform takes effect, you must still complete re-certification under the current rules. Plan accordingly. Prepare your clinical evaluation strategy. The broader evidence acceptance could change how you structure your CER. Start identifying relevant published literature and bench testing data now. Monitor the legislative process. Subscribe to updates from the European Commission, RAPS, and MedTech Europe to track amendments during trilogue negotiations.

CertHub's QM Audit Conformity Checker simulates QMS audits against ISO 13485, MDR Annex IX, and FDA requirements, giving you a clear picture of where you stand today and what will change tomorrow. Whether you're a startup preparing your first CE mark or an established SME managing a portfolio of legacy devices, having audit-ready documentation is the foundation that makes all future regulatory transitions smoother.

The Bottom Line

The MDR/IVDR 2.0 proposal represents the most significant reform of EU medical device regulation since the MDR itself replaced the MDD in 2017. For SMEs, it signals genuine relief: lower classification burdens for software, elimination of arbitrary re-certification cycles, standardized Notified Body timelines, and simplified pathways for innovative devices. But none of this is law yet. The manufacturers who will benefit most are those who remain compliant today while building the flexibility to adapt quickly when the reform arrives.

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Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. The proposed regulation COM(2025) 1023 has not yet been adopted. All references are based on publicly available sources as of March 2026.

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