Join us for a crucial in-person seminar on the latest developments in medical devices regulation, hosted by Axon Lawyers.

The EU medical devices regulatory framework is undergoing significant changes:

– Recent amendments to MDR and IVDR, including new shortage reporting requirements
– Mounting calls for comprehensive revision of EU medical devices law that will prompt more radical changes in the near fututre
– Phased roll-out of horizontal legislation affecting device design and deployment (e.g., AI Act, Batteries Regulation)

Stay ahead of these challenges and ensure your compliance strategy is robust and future-proof.

Key Topics

– Decoding the development of the Regulatory Lasagna of EU Medical Device Law
Unravel the complexities of overlapping regulations and their impact on your business.

– Supply Interruptions and Discontinuation Reporting
Navigate the new requirements under Article 10a MDR and IVDR, including risk assessment strategies.

– Industry Insights: Practical Experiences
Learn from real-world case studies and best practices.

Our extensive experience advising a very broad base of medtech clients positions us uniquely to guide you through these regulatory challenges. Benefit from our practical insights and strategic foresight.