EU Court Annuls Commission Decision: What Medical Device Manufacturers Need to Know
Background
The case concerns the medical device Inhaler Broncho-Air®. Back in the 1990s, German authorities prohibited its distribution due to a lack of clinical evidence. As a result, Germany initiated a so-called safeguard clause procedure under the old Medical Device Directive 93/42/EEC.After many years, in 2023, the European Commission issued a decision confirming the German ban—however, based on the Medical Device Regulation (EU) 2017/745 (MDR) that has been in effect since 2021.The manufacturer filed a lawsuit—and won.
The Court's Decision (EU Court, Judgment of 12.02.2025 – T-394/23)
The Court of Justice of the European Union declared the Commission's decision null and void. Reason: procedural errors.The MDR precisely outlines how products that pose a health risk should be handled (Articles 94–97 MDR). This includes particularly:
- Notification of all member states by the Commission (Article 95(4) MDR),
- Opportunity for member states to raise objections (Article 96(1) MDR).
Neither of these occurred. Thus, the Commission lacked the legal basis for its decision.The Court made it clear: even a violation of these formal procedural steps is sufficient to overturn a Commission decision.
Implications for Practice
This has important consequences for manufacturers and distributors of medical devices:
- Procedural rights are crucial: When national authorities or the EU Commission take action against a product, they must strictly adhere to the MDR procedures. Even formal errors can lead to annulment.
- Increased legal protection for companies: Manufacturers can successfully defend themselves if their participation rights or the consultation rights of member states are disregarded.
- Opportunities regarding national bans: Even older procedures that have dragged on for many years must now comply with the requirements of the MDR.
Practical Tips for Companies
- Early examination: If your product is challenged, it should be immediately checked whether the authorities adhere to the formal MDR requirements.
- Utilize legal remedies: Taking action against national prohibitions or Commission decisions can be worthwhile—even after many years.
- Strategic action: Documentation, clinical evaluations, and CE compliance form the foundation. At the same time, companies should consistently safeguard their rights in the procedure.
Conclusion
The EU Court has made it clear: The Commission cannot decide arbitrarily. Manufacturers are entitled to a proper procedure according to the MDR. In practice, this means that those who know their rights and assert them consistently can successfully defend themselves against administrative measures.
Source:
EuG, Judgment of 12.02.2025 – T-394/23