The safety of medical devices is of utmost importance for the health of patients around the world. Numerous regulations, particularly by the European Commission, are therefore commonplace in this industry. Just recently, the EU launched the AI Act to regulate artificial intelligence, with further requirements explicitly for the manufacture of medical devices. However, while the authorisation of medical devices is based on complex international standards, subsequent liability due to any product defects has not yet been part of international legislation. Medtech companies that sell their products on the German market should therefore obtain an overview of national liability law.

Neither the European Medical Devices Regulation nor the German Medical Device Law Implementation Act (MPDG) contain regulations on product liability. In fact, the industry-independent German Act on Liability for Defective Products and the German Civil Code are actually the basis for liability claims.

The Act on Liability for Defective Products is the key liability base. It provides for a no-fault claim for damages by the injured party if they have suffered physical damage due to a design, instruction or manufacturing defect. Damages due to defective monitoring of the product after market entry are not covered.

Proving a mistake is the key of product liability litigation. In principle, the injured party must pro-vide evidence that the product was defective. In practice, however, this is not an overly strict standard, as even a basic presentation of the relevant circumstances places a secondary burden of proof on the manufacturer. It is then up to the manufacturer to demonstrate that its product is in order.

However, this product liability does not only apply to traditional end-manufacturers, but also to companies that claim to be the manufacturer of a product by affixing their trade mark or that im-port a product into the European Economic Area. Even distributors can be held liable. In the event of a justified claim, they are obliged to name the manufacturer. If the manufacturer cannot be identified, the distributor is itself liable.

In addition to liability due to a product defect, fault-based liability of all market players in accordance with the general provisions of tort law must also be considered. In particular, this can also be used to assert a breach of a product monitoring obligation even after market launch.

Companies in the medtech sector should therefore protect themselves with a detailed documentation. This certainly begins with the manufacturing process due to the extensive EU regulations, but should by no means end with market authorisation. Admittedly, German law does not provide for such high compensation payments as in the USA, for example. Nevertheless, the conditions for a claim are quickly met and, in particular, are not linked to fault by the manufacturer.

Dr. Christoph von Burgsdorff, LL.M. (University of Essex)
Working Group Healthcare & Life Science

Luisa Kramer
Working Group Healthcare & Life Science