Every year, 7 April marks the “World Health Day” raising awareness of a specific health topic. Driven by the search for novel therapeutics, technologies or medical devices, the health and life science sector is one of the most dynamic and fast-growing industry branches in Europe. According to the European Commission, the medical devices sector in particular has become increasingly important for the healthcare of EU citizens and an influencer on expenditure. Employing 575,000 people in the EU it is a major employer in Europe, that represents ome 25,000 companies, of which 95% are Small and Medium-sized Enterprises (SMEs).
Given the importance of the sector, the professional management of Intellectual Property (IP) issues that arise when developing and bringing new medical devices to the market is crucial.
In our fact sheet written by Arty Rajendra and Mary Smillie, both solicitors at Rouse Leg, we take a closer look at central IP considerations for medical devices. The latter span a broad spectrum of products from simple mass-market products such as disposable gloves to highly technical complex and bespoke products such as surgical implants. They also include diagnostic kits and delivery systems for drugs. Some products are on the borderline between medical devices and medicinal products, and you may need to produce the same level of clinical trial evidence as needed for medicinal products to show that the devices are safe and effective.
Read the full fact sheet here.