On December 16, 2025, the European Commission published a legislative proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The proposal responds to persistent industry concerns about notified body capacity constraints, excessive documentation requirements for lower-risk devices, and disproportionate costs that have led some manufacturers to withdraw products from the EU market entirely. The amendments, if adopted by the European Parliament and Council under the ordinary legislative procedure, would represent the most substantial revision to the MDR/IVDR framework since the transition provisions were extended in 2023.
Key Proposed Changes to EU MDR
The December 2025 proposal targets several areas of EU MDR where stakeholders have documented the most significant compliance burdens:
- Proportionate conformity assessment for Class I devices: Enhanced procedural requirements for higher-risk Class I devices with measuring function or sterile presentation would be streamlined, with clearer self-certification pathways
- Simplified SSCP requirements: The Summary of Safety and Clinical Performance (SSCP) content requirements would be reformatted to reduce duplicative information already present in the technical documentation
- Periodic safety update report (PSUR) frequency adjustments: PSURs for lower-risk Class IIa devices would shift to a three-year cycle rather than annual, aligning with the existing cycle for Class I devices
- Notified body audit scope clarifications: Provisions would clarify the expected depth of unannounced audits and product sample testing to reduce variability across notified bodies
Changes Proposed for IVDR
The IVDR amendments focus primarily on the classification and conformity assessment pathways for in vitro diagnostic devices. The proposal includes targeted revisions to the classification rules in Annex VIII to address devices that stakeholders argue were inadvertently reclassified to higher risk categories without a corresponding increase in actual risk. Additionally, the proposal introduces a mechanism for national competent authorities to issue time-limited market access permissions for IVDs where no certified alternative is available, addressing supply disruption risks that have emerged as legacy devices lose certification.
Legislative Timeline and Uncertainty
EU legislative proposals of this scope typically require 18 to 36 months to move through the European Parliament and Council before they can enter into force. Manufacturers should not assume that the proposed simplifications will be in place before 2027 at the earliest, and the final text may differ materially from the Commission's December 2025 proposal as it passes through the co-decision process. In the interim, compliance obligations under the current MDR and IVDR text remain unchanged.
What Manufacturers Should Do Now
Despite the legislative uncertainty, the proposal's publication signals the Commission's policy direction and can inform strategic planning. Manufacturers should monitor the legislative process through the European Parliament's ENVI committee, engage with trade associations that have standing to submit industry positions during the legislative process, and continue building MDR/IVDR-compliant technical files using current requirements rather than anticipating changes that may not materialize as proposed. Sequence Group can assist with gap analysis against both current requirements and the proposed amendments to support scenario-based planning.
Frequently Asked Questions
What does the December 2025 EU MDR amendment proposal change?
The European Commission's December 16, 2025 proposal targets areas of EU MDR where stakeholders have documented the most significant compliance burdens. Key proposed changes include streamlined self-certification pathways for certain higher-risk Class I devices, simplified Summary of Safety and Clinical Performance (SSCP) content requirements, a shift to a three-year PSUR cycle for Class IIa devices, and clarified scope for notified body unannounced audits and product sample testing.
When will the proposed EU MDR and IVDR amendments take effect?
EU legislative proposals of this scope typically require 18 to 36 months to move through the European Parliament and Council before they can enter into force. Manufacturers should not assume the proposed simplifications will be in place before 2027 at the earliest, and the final text may differ materially from the December 2025 Commission proposal as it passes through the co-decision process. Compliance with the current MDR and IVDR text is required in the interim.
Should manufacturers change their MDR compliance approach based on the proposed amendments?
No immediate changes to compliance activities are warranted. Current MDR and IVDR obligations remain fully in force. Manufacturers can use the proposal's publication to inform scenario-based strategic planning and should monitor the legislative process through the European Parliament's ENVI committee. Engaging trade associations that have standing to submit industry positions during the legislative process is also advisable.