Module 17 2024

Howard Dobbs

04/12/2024

Now, what about the UK?

• The applicable legislation is the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended in 2024) • The applicable guidance is MHRA Guidance, January 2021, version 3: Virtual manufacturing of medical devices (updated 1 July 2023) • The Regulation (section 14) describes the requirements for systems and procedure packs and for devices to be sterilized • The MHRA Guidance focuses on the requirements for OBLers (called VMs in the guidance).

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

35

MHRA Guidance, January 2021 Section 2: What has changed?

• There are 2 new product markings: the UKCA mark which is valid in GB and the CE UKNI which is valid in NI. • The EU CE mark will continue to be recognized in GB until at the latest 30 June 2030. The exact deadline depends on the class of the device. After the deadline new devices placed on the GB market will need a UKCA mark.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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