Legal Feature Product Liability for Medical Devices

Here we set out the European product liability regime as it applies to medical devices and examine key cases that indicate how the legislation is likely to be interpreted. Despite the fact that the strict liability regime has been in existence for many years, numerous issues have yet to be resolved and there continues to be a lack of harmonisation between the EU member states. We highlight a number of these issues and briefly discuss steps that the European Commission is taking to resolve them. We then discuss specific medical device aspects of product liability. Since the majority of product liability cases refer to labelling and information accompanying devices, we focus on device vigilance, safety reporting obligations and the importance of ensuring that product labelling reflects the developing safety profile of the products. Finally, the article provides some general guidance on how companies can protect themselves from product liability claims.