Make your Life Easier with the FREE Forms, ready for use in the Resource Center
The Clinical Evaluation Report (CER) has long been considered the “beating heart of the Technical Documentation” under the European Union Medical Devices Regulation (MDR) 2017/745. However, the complexity of these requirements has led to significant feedback from notified bodies and manufacturers alike. To address these challenges, a 2025 proposal to amend the MDR introduces specific measures designed to streamline the clinical evaluation process and reduce administrative burdens.
Broader Acceptance of Data Sources
One of the most significant shifts in the proposed amendments is the widening scope of clinical data. Manufacturers may soon be able to utilize data from scientific literature that has not necessarily been peer-reviewed to demonstrate the safety and performance of their devices.
Furthermore, the proposal expands the role of non-clinical testing methods, such as bench testing, in silico testing, and computer modelling. While traditional clinical data has been the standard, these non-clinical methods may be accepted as a replacement if the manufacturer provides an adequate justification in the technical documentation. This justification must be rooted in risk management, the nature of the device-body interaction, and the specific clinical performance claims.
Simplifying the Path to Equivalence
Currently, claiming equivalence—especially for Class III and implantable devices—often requires a contractual agreement with the manufacturer of the equivalent device to access their technical documentation. The 2025 proposal seeks to remove this contract requirement, significantly lowering the barrier for manufacturers to rely on data from established equivalent devices. By making these conditions more flexible, the amendment aims to reduce both the cost and the time required to generate new clinical data.
Efficiency in Reporting and Updates
To eliminate redundancy, the proposal introduces merged reporting. Manufacturers would no longer be required to produce a separate “PMCF evaluation report”; instead, findings from the Post-Market Clinical Follow-up (PMCF) can be integrated directly into the updated CER.
For manufacturers of Class III and implantable devices, the frequency of these updates will also become more flexible. Rather than following rigid administrative intervals, updates to the CER and the Summary of Safety and Clinical Performance (SSCP) will be tied to the specific needs of the device’s lifecycle.
Targeted Scrutiny and Support for Innovation
The Clinical Evaluation Consultation Procedure (CECP), which involves oversight by an expert panel, is also set to be streamlined. The proposal restricts this scrutiny primarily to Class III implantable devices, removing the requirement for Class IIb active devices intended to administer medicinal products. Additionally, CECP will not be required for certificate renewals or modifications that do not affect the benefit-risk ratio.
Finally, for those developing “breakthrough” or “orphan” devices, the proposal offers a proactive support system. Manufacturers can request early expert advice on their clinical development strategies before starting their evaluations. This measure is intended to prevent errors in data generation and ensure a smoother eventual assessment by notified bodies.
By embracing these future perspectives, medical device manufacturers can look forward to a more efficient regulatory landscape that prioritizes safety and innovation while reducing unnecessary procedural hurdles
Conclusion
The 2025 MDR amendment proposal signals a shift toward a more pragmatic and risk-based clinical evaluation framework: broader acceptance of diversified evidence sources, fewer administrative duplications through merged PMCF/CER reporting, and reduced barriers to equivalence for established devices. For manufacturers, this does not mean lower expectations—justifications will remain critical and must be firmly anchored in risk management, device–body interaction, and clearly defined performance claims. By preparing now (e.g., strengthening rationale structures, ensuring traceability of evidence, and planning lifecycle-based updates), companies can benefit from greater efficiency while maintaining the level of scientific robustness that Notified Bodies expect.