ARTICLE SUMMARY:
Across-the-board streamlining is proposed. Excerpted from Pathways’ Picks December 17: EU Overhaul, FDA Real-World Evidence Shift, and More Updates in End-of-Year Global Policy Bonanza.
The European Commission unveiled its highly anticipated legislative proposal to simplify the Medical Device and IVD Regulations December 16. The package did not disappoint, forwarding an abundance of legal changes targeted at reducing regulatory burdens for device firms, particularly small manufacturers. “A quick scan immediately reveals the inclusiveness of the revision can categorize it as a major overhaul, truly MDR 2.0 and IVDR 2.0,” said Gert Bos, a longtime medical device and notified body expert in the EU.
Here are some of the most significant provisions, among the larger list of proposed reforms:
- More options to satisfy MDR/IVDR data requirements. What qualifies as “clinical data” to support conformity assessments would be more flexible, including clearer acceptance of real-world data.
- Conformity assessment reined in. The new rules would restrain notified body conformity assessment for low and medium-risk devices (MDR Class IIa/b; IVDR Class B/C), requiring technical documentation assessment of only one representative devices for a generic device group—potentially covering an entire category or portfolio of a company’s products.
- No recertification mandate. The plan would remove the current five-year recertification mandate for all devices, instead tasking notified bodies with risk-based periodic reviews of marketed products.
- Predetermined change. It would formally introduce Predetermined Change Control Plans as a mechanism for device modifications into EU law and it would require notified bodies to inform manufacturers upfront what changes require approval or notification.
- Breakthrough path. The package would establish an official designation for breakthrough devices, as well as orphan devices, and grant them access to “priority and rolling review” by notified bodies.
- Structured dialogue. It would also provide a formal legal basis for substantive interactions between manufacturers and notified bodies, pre- and post-submission.
- Fee reductions. Notified body fees would be reduced for small companies and orphan devices and the Commission would be “empowered to set, level, and structure” fees.
- Centralizing governance. Several provisions would more tightly coordinate notified bodies (via NBCG-Med) and national competent authorities (via the European Medicines Agency).
- Software classification. The Commission proposes to rework how software is risk-classified under the MDR, setting low-risk Class I as the default, but defining circumstances when it could be Class IIa, IIb, or III based the condition being addressed and the software’s role to “drive” or “inform” clinical management.
- Less AI Act burden. Buried in the proposal is a provision that could significantly reduce the anticipated extra requirements from the EU AI Act. Currently, devices and IVDs must comply with all relevant AI Act requirements for high-risk systems in addition to MDR/IVDR rules. But a switch proposed in this week’s reform package would put them in a different category.
- Legislative debate is next. The plans will be submitted soon for consideration by EU lawmakers, i.e., the European Parliament and Council, so it is not yet clear if all elements of the proposal will become law and when the reforms will be enacted.
- Shorter-term measures. The Commission, however, will not be waiting on lawmakers for two priority areas: breakthrough devices and rules to standardize notified body procedures.