Module 17 2024

05/12/2024

MHRA Consultation of November 2024

• As the new UDI requirements would improve the traceability of medical devices, the MHRA propose to remove the requirement for UKCA marking for devices which have been through the UK conformity assessment process. This would mean that a UKCA mark would not be required on the device or its labelling (e.g. packaging and instructions for use). • This proposal would not impact the conformity assessment process. Marking requirements from other product safety or health and safety legislation, such as electrical equipment safety and restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment, would still apply to certain devices, where applicable. It would be the manufacturer’s responsibility to ensure they meet the appropriate requirements for other applicable legislation.

The Organisation for Professionals in Regulatory Affairs

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MHRA Consultation of November 2024

Assimilated EU Law The Medical Devices Regulations 2002 transposed relevant EU Directives into domestic law and is therefore considered to be ‘assimilated’ EU law. The Regulations contain references to a number of other pieces of assimilated EU law, which also form part of the regulatory framework for GB. Four of the pieces of assimilated law that form part of GB’s current regulatory framework are due to be sunsetted – i.e. they are due to expire – on 26 May 2025 (before any new Regulations are in force) As these four regulations are still in use, the MHRA proposes to maintain the regulatory status quo by removing the revocation date of these four pieces of assimilated law so that they continue to apply in GB until such time as they are replaced with updated UK law. Allowing these regulations to be sunsetted on 26 May 2025 would cause significant disruption to the regulatory framework and, consequently, negative impacts on patient safety.

The Organisation for Professionals in Regulatory Affairs

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