Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Registering devices with the MHRA

• All devices will need to be registered with MHRA from 1 Jan 2021 • Can be done from 1 Jan • Must be done from 1 May for Class III and Class IIb Implantables, active implantables and IVD List A • Must be done from 1 Sep for other Class IIb, Class IIa, IVD List B and self-test IVDs • Must be done from 1 Jan 2022 for Class I and general IVDs • Custom-made devices should be registered based on risk class of the device

The Organisation for Professionals in Regulatory Affairs

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UKCA Marking

• Continue to be valid until 30 June 2023 • Certificates from UK Notified Bodies are acceptable • Class I and General IVD self declarations remain acceptable

• Applicable from 1 Jan 2021 • From 1 Jul 2023 , all UK devices must have UKCA • Only UK Approved Body can issue UKCA mark and must be used Big But…..

The Organisation for Professionals in Regulatory Affairs

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