Article 51(1) of Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter referred to as MDR) establishes that devices shall be divided in classes I, IIa, IIb, and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII of the MDR.
Some specific requirements applicable to medical devices depend on the device classification. Requirements applicable to higher classes of devices are more stringent, as their risk is higher…
