Regulatory CONTEXT 🌍
Team-NB and non-member NOs have been working together since early summer 2025 to develop the following proposal. Their positions are presented on several major topics as part of the ongoing revision of the Regulations.
Six working groups addressed the following topics:
- Early Dialogue
- Article 61.10 and Clinical Data
- Digitization
- Device Coding
- Designation and Reassessment of O.N.s
- Innovative (“breakthrough”) devices
ANALYSIS
Early Dialogue 🤝
The NGO group is calling for the establishment of an early-stage dialogue aimed at creating a framework for proactive communication between manufacturers and notified bodies. The goal of this dialogue is to identify potential roadblocks before the full compliance dossier is submitted. This approach would improve transparency, reduce evaluation times, and accelerate the availability of devices on the market, while maintaining regulatory requirements and confidentiality.
Article 61.10 of the MDR 🧬
With regard to Article 61.10 of the RDM, the group proposes clarifying its scope of application to avoid unnecessary debates about the nature of the clinical data required.
He suggests broadening the definition of “clinical data” to include real-world data* (RWD), post-marketing information, and relevant international sources. The concept of clinical evidence would be redefined to also incorporate relevant non-clinical data, better reflecting the reality of evaluation practices. These adjustments aim to remove the artificial barrier between clinical and non-clinical data without increasing the regulatory burden.
*All information collected outside of controlled clinical trials. For example, data from routine medical practice that reflect how a medical device or test is actually used in everyday care, with real patients, under non-experimental conditions.
Digitization 💻
With regard to digitization, the group is promoting the transition to fully digital processes, including machine-readable documentation, remote audits, and the use of simulation methods (“in silico” or digital modeling and simulation) to demonstrate the safety and performance of devices. These tools would facilitate faster evaluations and help reduce the reliance on animal testing.
Revision of the Coding System 🔢
A revision of the coding system for DM/DMDIV is also proposed to simplify the current structure. Consolidating and eliminating redundant codes would reduce complexity without affecting the safety, performance, or regulatory status of the products. Transition periods and implementation guidelines are recommended to ensure consistent implementation.
Designation and Reassessment of O.N.s 🏛️
With regard to the designation and reevaluation of Notified Bodies, the group calls for a faster, more centralized, and less bureaucratic process. It recommends clearly distinguishing between extensions of the scope of initial designations, streamlining communication between competent authorities, and ensuring structured continuity of certificates in the event that a notified body ceases operations.
Innovative Devices 🚀
Finally, for innovative devices that are of major clinical interest but for which data are limited, the group suggests creating a coordinated European “breakthrough” pathway. This mechanism would allow for the granting of conditional certificates accompanied by specific post-market requirements, under the supervision of the European Commission or expert panels.
View the Proposal – Revision of the DM and DMDIV Regulations