Decision (EU) 2025/1324 — Published on 7 July 2025
The European Commission has adopted Decision (EU) 2025/1324, amending Implementing Decision (EU) 2019/1396, with the objective of strengthening the role of expert panels in the evaluation of high-risk medical devices. This initiative further reinforces the EU’s commitment to scientific excellence, transparency, and patient safety under the Medical Device Regulation (MDR) (EU) 2017/745.
What’s new?
This new Decision introduces important updates:
- Administrative improvements to optimize the functioning of existing expert panels.
- The creation of a new specialized expert panel, specifically tasked with supporting the European Commission and Notified Bodies in the clinical and technical assessment of high-risk devices.
Why is this important?
These changes will have significant impacts on the regulatory landscape for medical device manufacturers:
- Greater consistency and quality in the evaluation of complex technologies such as implantable devices and AI-based software.
- Enhanced patient safety, thanks to independent expert input in borderline or uncertain cases.
- Improved efficiency in decision-making, with a more structured and agile expert infrastructure.
Implications for manufacturers
While this update may seem procedural, it introduces several considerations that manufacturers must address as part of their EU MDR compliance and market access strategies.
- Tighter clinical scrutiny
The new panel is expected to play an increasingly active role in evaluating the quality of clinical evidence, particularly during consultations under MDR Article 54. For high-risk or innovative devices, this will require careful preparation of Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) plans.
Recommendation:
Strengthen your clinical evidence early. Anticipate potential scientific questions and ensure that your documentation aligns with MDCG guidance and evolving panel expectations.
- Potential timeline extensions
The involvement of expert panels can introduce additional review cycles, depending on the device classification and associated risks. While the objective is to improve consistency and safety, these additional steps may result in extended time-to-market, particularly if clarifications or updates are required during the process.
Recommendation:
Incorporate regulatory buffers into your launch timelines and be prepared for an iterative consultation process.
- Closer coordination with Notified Bodies
Notified Bodies may increasingly seek expert panel opinions for high-risk devices, particularly where technologies are novel or present marginal clinical benefit-risk profiles. As a result, early engagement and alignment with your Notified Body will become critical.
Recommendation:
Involve regulatory experts early in the development process and establish clear communication with your Notified Body to anticipate if and when expert panel input will be requested.
- Enhanced market credibility
A positive opinion from the expert panel can contribute not only to regulatory approval but also to discussions with Health Technology Assessment (HTA) bodies, payers, and hospital procurement groups. In a value-based healthcare environment, this feedback can strengthen a company’s credibility and support reimbursement strategies.
Recommendation:
Use expert panel engagement as a strategic milestone within your reimbursement and market access plans, particularly in jurisdictions with stringent clinical scrutiny such as Germany and France.
Final considerations
Decision (EU) 2025/1324 reflects the EU’s determination to raise standards for the approval of medical devices. For manufacturers, this is a prompt to refine regulatory strategies, improve clinical evidence generation, and proactively manage timelines and stakeholder engagement.
In this evolving landscape, preparing thoroughly and aligning with regulatory expectations will be key not only to compliance but also to market leadership.
If you would like to discuss how these updates could affect your pipeline or regulatory approach, Chemsafe Srl’s experts are available to support you.
