Europe – Cyber Security

The increasing number of connected medical devices and ongoing digitisation in healthcare
brings new market opportunities for the manufacturer and, more importantly, improvements in patient care. At the same time, it presents new and different types of risks to the safety, security, and privacy of medical devices. These connected medical devices range from sensorbased technologies such as wearables to software as medical device such as mobile medical apps and also to implantable medical devices such as pacemakers. To ensure the safe and secure use of medical devices, state of the art regulatory frameworks are necessary. Coherent, consistent, and harmonised regulatory requirements are key to a high level of cybersecurity and competitiveness at the European and international levels. Currently, however, an increasing amount of national cybersecurity requirements and guidances are published, which leads to an increased fragmentation within the European frameworks. Since cybersecurity evolves on a regulatory and technological level this paper document is intended to reflect the current state of the art at the time of creation only. There are few cybersecurity experts today and it is likely that it will continue to be a similar situation in the foreseeable future; therefore, it is a goal of this paper to make conformity assessment(s) of cybersecurity as efficient as possible without compromising the quality…