EU Proposal to Simplify MDR and IVDR Rules (2025)

On 16 December 2025, the European Commission published Proposal 2025/0404 (COD) to amend the EU MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). The proposal aims to simplify regulatory requirements for medical devices and IVDs, reduce administrative burden, and improve efficiency—while maintaining a high level of patient safety, innovation, and EU competitiveness.

Objectives of the MDR/IVDR Simplification Proposal  

This comprehensive 170-page proposal seeks to make the EU medical device regulatory framework easier, faster, and more effective.

Key objectives include:

• Reducing unnecessary regulatory complexity

• Improving predictability for manufacturers and notified bodies

• Supporting innovation and competitiveness

• Preserving high standards of patient safety and public health protection

Key Proposed Changes for Medical Device Manufacturers  

The proposal introduces several changes that could significantly affect manufacturers across the EU:

• Medical Device Software (MDSW) Classification
  Rule 11 would be amended, potentially allowing a broader range of MDSW to qualify as Class I, reducing conformity assessment burden.

• Reduced Re-Certification Requirements
  Removal of the fixed five-year validity period for notified body certificates, replaced by a risk-based approach to re-certification.

• Expanded Use of eIFUs
  Extension of electronic Instructions for Use (eIFUs) to professional-use IVDs for near-patient testing, supporting digitalization.

International Reliance and Regulatory Cooperation  

The proposal reinforces international alignment by introducing EU participation in the Medical Device Single Audit Program (MDSAP).

This move would support regulatory reliance, reduce duplication of audits, and facilitate global market access for manufacturers operating across multiple jurisdictions.

Expanded Flexibility for In-House Devices  

The proposal expands the scope of MDR/IVDR Article 5(5) on in-house devices by:

• Allowing transfer of in-house devices between EU health institutions

• Supporting public health needs and emergency preparedness

• Removing the requirement that no equivalent CE-marked device exists on the market

These changes aim to improve patient access while safeguarding public health interests.

New Special Pathways for Innovation  

To further promote innovation, the proposal introduces new regulatory pathways for:

• Orphan medical devices

• Breakthrough technologies

These pathways are designed to accelerate access to innovative solutions addressing unmet medical needs.

What Happens Next?  

The proposal will now undergo review and negotiation under the ordinary legislative procedure (COD) involving the European Parliament and the Council.

Manufacturers should monitor developments closely and assess how the proposed changes could impact classification, certification strategies, and innovation planning.

Internal links:

• EU MDR Consulting

• EU IVDR Consulting

External links:

• European Commission legislative proposal 2025/0404