Module 18 2021

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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Risk Classes

• The UK MDR classifies all medical devices as per the level of risk associated with their use.

• There are 4 classes of medical devices, sorted I to III in order of increasing risk: Class I – low risk Class IIa and Class IIb – medium risk Class III – high risk • Which class a device fits into is determined by the rules laid out in Annex IX. – Part II of the Medical Devices Regulations 2002, Annex IX [as modified by Part II of Schedule 2A to the Medical Devices Regulations 2002]

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