The new CE marking for medical devices proposed by the European Commission marks a potential turning point for the European regulatory framework.
On 16 December 2025, the European Commission published a proposal for a targeted revision of Regulation (EU) 2017/745 on medical devices (MDR), aiming to improve the efficiency of the system while maintaining a high level of patient safety.
The proposal is available on the European Commission website:
https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
Key takeaway: the 2025 revision is not based on the view that “the MDR is too demanding”, but rather on the observation that “the system has become too unpredictable and too burdensome in its implementation.”
Source: Qualitiso
CE marking under MDR: what could change for manufacturers
Since the MDR became applicable in May 2021, the CE marking process has become significantly more complex, particularly for small and medium-sized enterprises and for devices addressing limited patient populations.
In its proposal, the European Commission explicitly acknowledges the disproportionate impact of certain MDR requirements and the need to introduce greater proportionality, without lowering safety standards.
Better control of certification costs
The Commission recognises that the costs charged by notified bodies have increased significantly under MDR, creating barriers for:
- micro-enterprises and SMEs,
- devices with low production volumes,
- devices intended for small patient populations.
The proposal therefore seeks to improve cost proportionality, in line with the general principles of EU law, while preserving the independence of notified bodies.
Moving away from systematic certificate renewal
Under the current MDR framework, CE certificates are generally valid for five years, regardless of the device risk profile or technological maturity.
The proposed revision introduces the possibility of risk-based review cycles, allowing notified bodies to adapt the frequency of reassessment according to:
- device risk class,
- clinical maturity,
- post-market safety data.
This approach is intended to improve predictability and resource allocation within the certification system.
Targeted adjustments to device classification
The European Commission also addresses concerns related to over-classification of certain device categories under MDR.
The proposal mentions targeted adjustments for specific product groups, including:
- certain medical software (SaMD),
- reusable surgical instruments,
- specific accessories to active devices.
These adjustments aim to better align regulatory requirements with actual risk levels, while maintaining essential safety and performance controls.
Clinical evaluation: greater use of existing evidence
The new CE marking approach also affects clinical evaluation requirements.
The Commission proposes to:
- better recognise existing clinical data,
- clarify equivalence criteria,
- allow greater reliance on non-clinical data where scientifically justified.
These elements are detailed in the explanatory memorandum accompanying the proposal:
https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en
Recognition of well-established technologies
The proposal explicitly recognises that certain technologies have a long history of safe clinical use.
For these well-established technologies, the Commission proposes a more proportionate application of MDR requirements, reflecting the lower level of residual uncertainty compared with highly innovative devices.
Adjustments to PRRC-related obligations
The European Commission also addresses organisational constraints introduced by MDR, particularly those linked to the Person Responsible for Regulatory Compliance (PRRC).
The proposal clarifies that proportionality should apply, especially for SMEs relying on external PRRC arrangements, while preserving the role of the PRRC as a cornerstone of regulatory compliance.
Simplification of post-market obligations
Post-market surveillance requirements would also be adjusted, including:
- reduced frequency of Periodic Safety Update Reports (PSURs),
- extended vigilance reporting timelines (up to 30 days for non-serious incidents).
These changes aim to reduce administrative burden while maintaining effective safety monitoring.
Increased digitalisation of regulatory processes
The proposed new CE marking framework is part of a broader strategy to strengthen digitalisation, including:
- improved use of EUDAMED,
- structured data exchanges between manufacturers, notified bodies and authorities,
- better traceability and transparency across the lifecycle of medical devices.
Conclusion
The proposal for a new CE marking for medical devices, published on 16 December 2025, reflects the European Commission’s intention to recalibrate the MDR framework.
It does not constitute deregulation, but rather a targeted adjustment designed to restore predictability, proportionality and sustainability, while preserving the high level of patient protection required under EU law.
For manufacturers, the challenge remains to fully comply with the current MDR, while anticipating potential future changes and assessing their impact on certification strategies.
At BluePharm, we support medical device manufacturers in analysing European regulatory developments, securing CE marking strategies and aligning clinical and regulatory pathways in an evolving regulatory environment.
See article : CE marking and reimbursement: 2024 marks a turning point for clinical rigor in Europe
