MDCG Updates Guidance on IVD Classification under IVDR
MDCG has released an updated guidance document to support consistent classification of IVDs under IVDR. The revision includes new examples, updated rules for POCT and self-testing devices, and detailed guidance on companion diagnostics. It also addresses software as a medical device. The document serves as a reference point for both manufacturers and notified bodies.
Key changes in MDCG 2020-16 rev.4
The revised guidance introduces:
- new classification scenarios for virological (e.g., SARS-CoV-2) and genetic tests, including those using molecular techniques,
- interpretation guidance for point-of-care tests (POCT), where classification may depend on user supervision,
- clarified criteria for self-testing devices, such as glucose meters, pregnancy tests, and diagnostic strips.
The document also addresses the growing importance of IVD software, outlining how to classify it based on its function in the diagnostic decision-making process.
Companion diagnostics (CDx)
Special attention is given to companion diagnostics, i.e. IVDs used to support therapeutic decisions related to specific medicinal products. The updated guidance covers:
- requirements to demonstrate the link between the test and the drug,
- expectations for clinical evidence,
- recommendations for post-market performance monitoring.
Practical implications of the guidance
Although the guidance is not legally binding, it is widely adopted as a standard by notified bodies and competent authorities across the EU. It plays a critical role in:
- interpreting risk classification criteria,
- preparing technical documentation,
- ensuring compliance with IVDR.
This update supports a harmonised interpretation of IVDR and helps facilitate consistent market access for IVDs throughout the EU.