Module 17 2024

05/12/2024

To be eligible for the proposed framework, products will need to (note: requirements changed in Nov 2024): Chapter 14: Alternative Routes to Market • Fall within the scope of the UK Medical Devices Regulations • Be classified in accordance with UK Medical Devices Regulations. • Have English language labelling and packaging; • Be supplied with an implant card and leaflet in compliance with the updated requirements in the new UK Medical Devices Regulations, where applicable • Comply with GB requirements for all other relevant product requirements such as those for machinery, electronics compatibility, units of measurement, and labelling materials of concern where applicable (for example, for substances which are carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1A or 1B, or could result in sensitization or an allergic reaction)

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 Have a UK Responsible Person, the name and address of which would be included on the product labelling or the outer packaging, or the instructions for use (this may be via over-labelling, and MHRA will also investigate the ability for digital labelling or digital label solutions in a future consultation)  Have a physical unique device identifier (UDI) on parts and labels in compliance with the updated requirements in the new UK Medical Devices Regulations or the CRC (comparable regulator countries) There does appear to be an inconsistency in this requirement as the CRC requirements on UDI will not be the same as the UK MDR requirements (e.g., EU and US UDI requirements are different, so both cannot be compliant with the UK MDR), so the main function of UDI, the traceability of medical devices will not function fully as it will require the user of the device (healthcare institution) to have compatible reading systems for the different UDI specifications. • Comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations 2002, which are expected to come into force in 2025 • Register with the MHRA The proposed framework would provide a certificate of international reliance that can then be used to register with the MHRA and gain access to the GB market but would not provide a UKCA marking or UKCA certification. Chapter 14: Alternative Routes to Market

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