We offer comprehensive legal counsel at the intersection of healthcare, technology, and regulatory compliance.

Our practice focuses on EU Artificial Intelligence Regulation, Intellectual Property Law, Competition Law, Crypto & Blockchain, Data Protection, and the Data Act, addressing the complex legal and regulatory challenges unique to the medical devices sector.

EU Artificial Intelligence Regulation

Medical devices increasingly incorporate AI for diagnostics, monitoring, and treatment guidance or the software itself can be considered a medical device. We advise on compliance with:

• the EU AI Regulation, 
• the EU Medical Device Regulation,
• the EU in Vitro Diagnostic Medical Devices Regulation

ensuring AI-driven devices meet safety, transparency, and accountability standards while mitigating regulatory and liability risks.

Data Protection and the Data Act

Medical devices often process sensitive patient data, requiring rigorous compliance with GDPR and the EU Data Act. We advise on lawful data processing, cross-border data transfers, cybersecurity, and privacy risk management, ensuring regulatory compliance and patient trust.

Crypto & Blockchain

Blockchain technologies are increasingly applied in device supply chains, clinical data integrity, and secure digital registries. We provide guidance on implementing blockchain solutions while navigating EU regulatory requirements.