The Changing Face of Medical Devices and In Vitro Diagnostic Medical Devices: White Paper on the New Regulations

Our regulatory team across Belgium, Germany, Italy, the Netherlands and the UK has analysed the extensive texts of the new medical devices regulations, identifying key questions and issues which are raised following the impeding introduction of the regulatory reform.

Our team's findings have been summarised in a white paper. This white paper deals with many of the key aspects of the regulations going a.o. into the extension of the scope of legislation (including a.o. certain devices of a “non-medical” nature), better supervision of independent assessment bodies, clear rights for economic operators, stronger transparency and surveillance requirements, stronger requirements for clinical evidence, and transitional provisions which require careful analysis especially products currently on the market.

While many of the details of the Regulations remain to be decided via so-called secondary legislation, either through delegated or implementing acts, it is important for industry to already be aware of the challenges which may lie ahead. The timely adoption of these acts will be crucial to allow adequate preparation for the regulations of all stakeholders involved.