Feedback to the European Commission’s Targeted Evaluation

ProductLife Group (PLG) is a global regulatory consulting company specializing in regulatory affairs, quality, and compliance. Our team collaborates with regulators, manufacturers, and healthcare professionals to streamline product approvals and market access with a high level of quality, ensuring patient’s benefits. PLG is pleased to contribute to the European Commission’s Targeted Evaluation, serving as the voice of our customers to ensure their challenges and needs are effectively addressed.
We recognize that the two texts published in 2017 provide a precise framework to cover the primary objectives recalled in the first recitals as well as the identified areas for reinforcement. To uphold the New Approach principles, the regulatory framework must remain flexible and proportional to foster innovation while ensuring patient safety. However, implementation challenges raise concerns about whether these regulations meet their primary objectives.
In 2025, assessing the tangible safety benefits of new regulatory requirements, including PSURs, the Clinical Evaluation Consultation Procedure, and Expert Panel consultations, remains challenging. Moreover, growing evidence of supply disruptions, the reduction of product variants, and the market withdrawal of certain MDs and IVDs, attributed to regulatory constraint, introduces new risks for patients and healthcare professionals.
Increasing time, cost and unpredictability of conformity assessments remain a major challenge, particularly for startups and SMEs. This issue disproportionately impacts low- to intermediate-risk medical devices, delaying market entry and increasing financial burden. Hence, a mechanism is needed to consult either the upstream class at the European level and ensure predictable evaluation routes and criteria.
The impact of the New Approach extends beyond patient safety to the balance between regulatory demands and industry sustainability. Thus, the key question for the European Commission and market stakeholders is: How can the regulatory environment adapt to technological advances and the evolving lifecycle of medical devices?
Based on our extensive expertise and industry insights, we propose seven key areas for improvement to address the question above:

1. Transparency in Cost and Timelines:
   • Greater predictability in costs and timelines is essential for manufacturers.
   • Cost transparency should be enhanced with lump-sum schemes by device classes.
   • Maximum evaluation times and fixed submission slots for documentation should be defined in regulations.
2. Progressivity and International Convergence:
   • Proportionality in conformity assessments should be improved, especially across device classes and for Notified Bodies.
   • Greater regulatory alignment with international frameworks, such as the IMDRF initiatives, is needed.
   • Full adhesion to the MDSAP program is crucial.
   • Compliance to clinical evaluation should be more flexible, taking into account retrospective data, particularly for legacy devices, to ensure meaningful clinical evaluation while maintaining market access.
3. Arbitration Mechanisms and Harmonization Between Notified Bodies and Regulators:
   • Economic operators need clearer regulatory guidance and arbitration mechanisms to resolve interpretation-related divergences.Greater predictability is needed in the conformity routes and Notified Bodies’ expectations.
   • Establishing an EU-level arbitration system would help achieve consensus and common interpretation based on real cases, thus minimizing inconsistencies in regulatory decisions across Notified Bodies and Competent Authorities.
4. Accelerated environment for the deployment of processes and systems:
   • EUDAMED: Continued delays in full implementation hinder regulatory efficiency. Proportionality in UDI requirements across device classes should be ensured. Obligations for distributor registration need clarification.
   • EURL: Delays in the designation of essential EURLs create bottlenecks for high-risk IVDs. Efforts should be made to streamline application and evaluation process. Existing networks should be leveraged to share best practices and harmonize working methods.
   • Expert Panels (EPs): Limited involvement of EPs restricts their ability to support manufacturers early in development. Efforts should be made to enable EPs to provide guidance upstream.
5. Support for Innovation and Orphan Devices Through Adapted Regulatory Pathways:
   • A European equivalent of the FDA Breakthrough Device Program should be developed, based on an adaptive approach rather than a fast-track system.
   • The MDR treats software and AI-enabled medical devices as traditional hardware, making approvals slow and costly. A tailored approach is needed.
   • Orphan Devices: Current regulatory efforts should focus on global measures, such as class-specific evaluation procedures, rather than broad, generalized solutions.
   • The development of regulatory sandboxes for innovative and orphan devices is a priority.
   • A structured process for early scientific advice must be complemented by mechanisms to support innovative projects at the European level.
6. Minimize redundancies by an adapted regulatory system
   • Reduce administrative burdens by implementing proportionate assessment based on device risk class.
   • Simplify processes for subsidiaries of larger groups in the sector (e.g. structuring of national branches).
   • Adapt the PRRC concept to the economic operator’s status, structure, and size.
   • Improve alignment between pharma and medical devices regulations, particularly for combination products requirements for manufacturers.
7. Governance and Centralization:
   • Stronger governance is needed to anticipate regulatory challenges and improve oversight efficiency.
   • Better coordination between EMA, the European Commission, and Member States is crucial for consistent regulatory interpretation across Europe.

Proposed Solutions
• Improve structured dialogues between manufacturers and NBs to streamline compliance and reduce redundant exchanges. Promote best practices through initiatives like NoBoCap and JAMS 2.0, to broaden communication efforts.
• Adapt the 5-year re-certification requirement based on device risk class and novelty. Strengthen post-market monitoring by integrating PMS, PMCF, and PSUR into the process.
• Permit case-by-case use of retrospective clinical data to support clinical evidence and regulatory decisions.
• Implement a progressive and phased conformity assessment approach for legacy devices to maintain market access and ensure safety and performance.
• Expedite the harmonisation of standards to streamline regulatory compliance and interpretation across Europe, as well as developing more common specifications.
• Restrict national provisions affecting product design (e.g. sterilization, maintenance, traceability, etc.) and reimbursement to prevent compliance inconsistencies of medical devices.