Module 18 2021

Exclusions

Certain things are excluded from the remit of the medical device regulations and therefore products containing certain things cannot be considered as Medical Devices: e.g.

• Most human derived products • Viable animal tissues

11

11

UK Medical Devices Regulations 2002

Transposes into UK law the three EU Medical Devices Directives

• Medical Devices (93/42/EEC) – Part II of UK MDR • Active Implantable Medical Devices (90/385/EEC) – Part III of UK MDR • In Vitro Diagnostics Medical Devices (98/79/EC) – Part IV of UK MDR

A product may be a Medical Device, but could be regulated as an Active Implantable Device or an In Vitro Diagnostic Medical Device.

Active Implantable Devices must be both (i.e. active and implanted).

In Vitro Diagnostic Medical Devices are intended for the examination of specimens derived from the human body and thus may not come into contact with the body.

12

12

6