PRODUCT LIABILITY RISKS FOR MEDICAL DEVICES
CD: Reflecting on recent months, what do you consider to be the major trends and developments shaping the medical device industry? What key issues have manufacturers been dealing with?
Burk: Medical device manufacturers are currently facing two key challenges in Germany and the European Union (EU): the digital connection of medical devices, and the integration of control and monitoring functions of several medical devices. For German statutory health insurance patients, 2021 will bring a new electronic patient record into which all results from digital medical devices flow and can be viewed by both the physician and the patient. In addition, the Medical Device Regulation (MDR) will come into force on 26 May 2021, after being delayed by one year due to the coronavirus (COVID-19) pandemic. Various components, in particular the central medical device database Eudamed, are not yet functional. At the same time, in Germany alone, almost 50 implementing acts in implementation of the MDR must be observed. Compliance with the new regulations is a challenge, especially from a liability perspective.
Koshal: The medical device industry used to consist mostly of devices which were implanted in a patient and then periodically monitored by physicians. Today, the industry is increasingly moving toward connected devices which monitor and track chronic diseases in real-time. These devices promise to amass a considerable amount of patient data for use by healthcare providers, and as such are increasingly caught up in a complex web of regulatory and privacy considerations. This trend brings about significant therapeutic possibilities but also raises the prospect of new risks for manufacturers. These risks include negligent or defective design or manufacture, the need for additional warnings, and a heightened need for compliance with laws governing the collection and retention of personal health information.
Apr-Jun 2021 issue
Gleiss Lutz
Goldman Ismail Tomaselli Brennan & Baum LLP
McCarthy Tetrault