EU MDR Update

On December 16, 2025, the European Commission published (COM(2025) 1023), a proposal to amend Regulation (EU) 2017/745 (MDR).

Software (SaMD) Reclassification (Rule 11): Software classification rules under Annex VIII are adjusted to allow lower-risk standalone software (e.g., patient self-management apps) to be classified as Class I, eliminating the requirement for Notified Body involvement unless intended for "serious" or "critical" clinical situations.

Reusable & Accessory Devices: Reusable surgical instruments and certain accessories for active implantable devices face reduced risk classifications, shifting them away from mandatory Notified Body assessment.

Certificate Validity: The proposal eliminates the strict 5-year maximum validity limit on Notified Body certificates. Instead, certificates will remain valid indefinitely, shifting oversight toward continuous, risk-based surveillance audits rather than full recertification cycles.

Broader Acceptance of Alternative Data: Manufacturers can leverage non-clinical evidence—such as computational modeling, in silico testing, bench testing, and published peer-reviewed literature—to establish safety and performance.

Proportionate Rules for Known Devices: Formalized definitions for "Well-Established Technologies" (WET) reduce the need for redundant clinical trials when devices have a long, stable safety history on the market.

PRRC Requirement Eased: The qualification standards for the Person Responsible for Regulatory Compliance (PRRC) are simplified. Additionally, SMEs relying on external PRRC consultants will no longer be required to have them "permanently and continuously" on hand, but simply "available" as needed.

Digitalization of Documentation: Manufacturers will be permitted to issue digital EU Declarations of Conformity and utilize electronic Instructions for Use (eIFUs) for broader device categories.

Repackaging & Relabeling: The proposal removes Notified Body certification and 28-day prior notification requirements for parallel traders repackaging products.

AI Act Harmonization: The proposal clarifies that AI-enabled medical devices are primarily governed under the MDR/IVDR pathway, preventing duplicate conformity assessments under the EU AI Act.

Breakthrough & Orphan Pathways: Priority review mechanisms and early scientific advice pathways are introduced for orphan devices and breakthrough technologies addressing unmet medical needs.

Regulatory Sandboxes: Member States can set up controlled sandbox environments to test emerging healthcare technologies alongside regulatory bodies.

Legislative Status: 

These proposals are currently undergoing review by the European Parliament and Council, with final adoption anticipated by late 2026.