The EU legislative framework on medical devices currently consists of two Regulations adopted and entered into force in 2017:
• Regulation (EU) 2017/745 on medical devices (MDR), applicable from 26 May 2021,
replacing the previous Directives 90/385/EEC on active implantable medical devices
(AIMDD) and 93/42/EEC on medical devices (MDD), through specific transition provisions, as amended;
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), applicable
from 26 May 2022, replacing the previous Directive 98/79/EC on in vitro diagnostic
medical devices (IVDD), through specific transition provisions, as amended.
These legislative acts are part of the EU harmonisation legislation on health, safety and
performance of products in the internal market, based on the principles of the “New Approach” and the “New Legislative Framework” policies. In this kind of legislation, the role of the harmonised European standards (hENs) is key: actually, for product characteristics, the content of legislation is limited to establishing essential requirements that products intended to be placed on the EU market must meet…
