EU IVDR Update

On December 16, 2025, the European Commission published (COM(2025) 1023), a proposal to amend Regulation (EU) 2017/746 (IVDR).

Removal of 5-Year Certificate Expirations:

Current Regulation: Certificates of Conformity issued by Notified Bodies automatically expire after a maximum of 5 years.  

Proposed Change: The 5-year maximum limit is removed. Certificates will no longer expire automatically; instead, Notified Bodies will perform risk-proportionate periodic reviews, reducing re-certification overhead for mature diagnostic platforms.  

Flexibility for In-House Diagnostics:

Current Regulation: Health institutions can develop and use in-house IVDs only if no equivalent commercial alternative exists on the market.  

Proposed Change: The strict "no commercial alternative" restriction would be removed, allowing hospitals and clinical labs to use and share in-house assays with other healthcare facilities under clearer conditions.  

Streamlined Performance Evidence & Consultations Elimination of PECP: 

The Performance Evaluation Consultation Procedure (PECP) for Class D (high-risk) IVDs is proposed to be removed to eliminate unnecessary procedural delays.

Expanded Evidence Acceptance: 

Expands acceptable sources of clinical and performance evidence, allowing manufacturers to leverage historical data and existing scientific literature more effectively.  

Small and Medium Enterprises  PRRC Rules: 

The requirement for a Person Responsible for Regulatory Compliance (PRRC) to be permanently and continuously available is relaxed for micro- and small enterprises to simply being "available" (e.g., via external consultants).

Proportional Auditing: 

Introduces predictable fee schedules, remote audit options, reduced audit frequencies, and limits on unannounced audits by Notified Bodies.  

Lower PSUR Frequency: 

Periodic Safety Update Reports (PSURs) will no longer require annual resubmissions for all risk categories; filing frequencies will be reduced (e.g., every two years or "as necessary" depending on risk).  

Support for Innovation & Digitalization Introduces structured "regulatory sandboxes" to allow real-world or simulated testing of breakthrough IVD technologies, adaptive software, and AI-driven diagnostics under regulatory supervision.  

Digital & Cybersecurity Rules: 

Modernizes requirements to explicitly address IVD software classifications, cybersecurity standards, and automated incident reporting.  

Legislative Status: 

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