Module 18 - Drug Device Combinations and Other Technologies

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.

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Manufacturer’s Responsibilities

A ‘manufacturer’ under the UK MDR is the person or company placing the product on the market in their own name.

The manufacturer is responsible for:

• determining if their product is a Medical Device and what classification applies. • review and comply with relevant Essential Requirements • implement the systems required • if applicable: apply to a Notified Body or UK Approved Body for Assessment and / or testing of devices • register the product with relevant Competent Authority

• make a Declaration of Conformity • apply CE Marking/ UKCA marking • operate Post Market Surveillance and Vigilance systems

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