Schalast | Medical devices

The effectiveness of healthcare is significantly enhanced by innovative medical devices. The Medical Device Regulation (MDR) sets rigorous standards for product safety, presenting considerable challenges to companies regarding its practical application.

The rising incorporation of Artificial Intelligence (AI) in medical applications, and thus in medical devices, further complicates matters for MedTech manufacturers, leading to unavoidable uncertainties among both manufacturers and notified bodies.

We advise comprehensively in all facets of medical device law, guiding our clients through the complexities of the MDR. Leveraging our specialised legal expertise in medical and pharmaceutical law, we offer our clients access to in-depth knowledge from a single source. Additionally, we assist our clients with product liability cases, as well as the planning and implementation of recommended actions and product recalls, encompassing internal company procedures.

In recent years, manufacturer liability has significantly tightened due to a landmark ruling by the European Court of Justice (ECJ). Specifically, in cases involving pacemaker recalls[1], the ECJ introduced the concept of “potential defect”, which has profound implications for liability. Moreover, the Proposal for a directive of the European Parliament and of the Council on liability for defective products introduces extensive presumptive rules concerning a product’s defectiveness and the causal relationship between defectiveness and any resultant damage.

Beyond this, we support our clients in navigating disputes related to competition law and advertising law, managing legal risks on their behalf. Where necessary, we represent our clients outside of court or in court, pursuing claims or defending third-party claims.


  • How can you differentiate between a medical device and a medicinal product?
  • Can software or an app be classified as a “product”, and under what circumstances is it deemed a medical device?
  • What legal standards are applicable to AI in medical devices?
  • Who bears responsibility for errors made by AI in a medical device?
  • What considerations are crucial for the approval, labelling and marketing of medical devices?
  • What steps should be taken in response to liability issues or a potential product recall?