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January 14, 2026
Approximately 5 minutes
Companion Diagnostics in the German Medical Devices Framework (BfArM)
Companion Diagnostics in the German Medical Devices Framework (BfArM)
Definition and Regulatory Classification
Companion diagnostics (CDx) are in vitro diagnostic medical devices (IVDs) that provide essential information for the safe and effective use of a corresponding medicinal product. According to Regulation (EU) 2017/746 (IVDR) Article 2(7), CDx are classified as Class C devices due to their critical role in therapy decision-making. This high-risk classification requires rigorous conformity assessment. Companion diagnostics - BfArM
Conformity Assessment Pathway
- CDx must undergo conformity assessment involving a notified body designated for Class C IVDs.
- The assessment includes technical documentation review, quality management system audit, and performance evaluation.
- For CDx linked to centrally authorised medicinal products, the notified body consults the European Medicines Agency (EMA) during the process.
- In Germany, BfArM as the competent authority oversees national aspects and coordinates with notified bodies.
Coordination with Medicinal Product Regulation
- CDx are developed in parallel with the corresponding drug (often during clinical trials).
- The medicinal product marketing authorisation (via EMA or national procedure) references the CDx in the summary of product characteristics (SmPC) and package leaflet.
- Changes to CDx intended use may require variation procedures for both the IVD and the medicinal product.
BfArM Role and Support
- BfArM provides guidance on CDx requirements in Germany, including application for conformity assessment and vigilance obligations.
- It participates in EU coordination groups (e.g., MDCG IVD subgroup) to ensure consistent interpretation of CDx rules.
- Manufacturers can consult BfArM for borderline or classification questions related to CDx.
Practical Implications
- CDx enable personalised medicine by identifying patients likely to benefit from or at risk from specific therapies (e.g., oncology biomarkers).
- Strict requirements ensure high reliability and clinical validity.
- Post-market surveillance includes vigilance reporting and performance follow-up studies.
This integrated approach under IVDR strengthens the safe use of targeted therapies in Germany and the EU by linking diagnostic precision to pharmaceutical efficacy. Companion diagnostics - BfArM
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