Module 17 2024

05/12/2024

Chapter 15 - Transitional Arrangements

Transitional arrangements for clinical investigations This will apply to clinical investigations which commence under the existing regulations before the new regulations take effect and which would not be completed before the new regulations take effect. Clinical Investigations which commence under the existing regulations before 1 July 2025 could continue to be conducted from 1 July 2025 providing any additional reporting requirements laid out in the new regulations for clinical investigations that commence on or after 1 July 2025 are met, such as around serious adverse events or device deficiencies. All these arrangements will be temporary, with a fixed time of application in place for each of them or a point of review. On expiry of the transitionary window, all products and clinical investigations will need to comply with the UK medical devices regulations in full.

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MHRA Consultation of November 2024

UKCA Marking

• Currently, medical devices or their sterile packs need a UKCA marking to be placed on the GB market if they have undergone the UK conformity assessment process. • In 2021, the MHRA invited views on whether the UK medical device regulations should define ‘Unique Device Identification’ (UDI) to improve the traceability of medical devices. • It remains the intention to require manufacturers to assign UDIs to medical devices before they are placed on the GB market and register these UDI numbers with the MHRA when a device is placed on the GB market. • The requirement that UKCA-certified products carry the UKCA mark potentially creates a barrier to market for manufacturers. Manufacturers are required to maintain a separate line of UKCA-marked products for the relatively small GB market.

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