MDCG publishes new guidance on clinical evidence for orphan IVDs

The latest MDCG 2026-6 guidance provides clarifications on clinical evidence requirements for in vitro diagnostic medical devices (IVDs) intended for rare diseases or orphan indications under the IVDR.

Key takeaways:

• Introduction of criteria to determine orphan IVD status, including a threshold of no more than 12,000 affected individuals per year in the EU.
• Acceptance of justified limitations in pre-market clinical performance data, supported by robust PMPF and PMS activities.
• Clarification on the use of non-clinical data, data extrapolation, and expert panel consultation to support clinical evidence generation.

This guidance aims to facilitate access to innovative diagnostic solutions for rare diseases while ensuring a proportionate and consistent application of IVDR requirements across the EU.

DOWNLOAD THE GUIDE MDCG 2026-6