Framework
EUMDR — Special Devices
The EU MDR 2017/745 establishes specific provisions for certain categories of medical devices that require additional or adapted requirements beyond the general framework. These include devices incorporating medicinal substances, devices made from tissues or cells of animal origin, implantable devices, devices with a measuring function, and custom-made devices, among others.
Overview
Background
Under Regulation (EU) 2017/745, the European Union introduced enhanced requirements for special device categories to address unique risks associated with these products. These provisions build on earlier directive requirements but introduce more rigorous assessment criteria and additional obligations for manufacturers and notified bodies.
Applicability
These provisions apply to manufacturers of medical devices that fall into specific categories defined by the MDR, including devices incorporating medicinal substances (Article 1(8)), devices made from non-viable human tissues or cells, devices utilizing animal-origin tissues (Annex XIII), custom-made devices (Article 52(8)), and devices with specific intended purposes that trigger additional requirements.