The General Court of the European Union (GC) has overturned a Commission decision banning a medical device. For manufacturers, this ruling makes clear: strict procedural rules can determine the success or failure of regulatory measures – and open up new avenues of defense.

GC strengthens the rights of medical device manufacturers

In its judgment of 12 February 2025 (Case T-394/23), the GC annulled the European Commission’s implementing decision prohibiting the medical device “Inhaler Broncho-Air®.” The background was a procedure ongoing since the 1990s concerning the clinical evaluation of the product.

Key findings of the Court

• Exceeding powers: The Commission was not entitled to adopt a decision under Article 96 of Regulation (EU) 2017/745, since no Member State had raised objections and the Commission itself had not identified any breach of Union law.
• Procedural error: The absence of mandatory notifications to the Member States violated essential procedural requirements.
• Legal consequence: The decision was declared void.

Practical implications

• Formal errors can be decisive. Manufacturers can challenge prohibitions by invoking procedural defects.
• Clinical evaluation remains mandatory. Products must be scientifically substantiated to secure market access.
• CE marking is no absolute safeguard. Even CE-marked products can be withdrawn from the market.
• Compliance pays off. Early risk prevention avoids lengthy and costly proceedings.

Recommendations for companies

• Align quality and risk management strictly with the MDR (Regulation (EU) 2017/745).
• Keep comprehensive documentation of clinical evidence.
• Initiate immediate legal review in case of regulatory measures.
• Always keep EU-wide proceedings on the radar.

⇒ Our conclusion: This judgment shows that manufacturers can successfully challenge unlawful prohibitions. At the same time, it underlines the high regulatory hurdles under EU medical device law. We support you with product approval, compliance, and litigation.