Module 17 2024

05/12/2024

Chapter 14: Alternative Routes to Market

Domestic Assurance - The MHRA will accept approvals from other international medical device regulators. Devices with approvals accepted by the MHRA could be subject to a domestic assurance process in which UK Approved Bodies could perform an abridged assessment of the device with appropriate levels of scrutiny to ensure that it meets the requirements of the UK Regulations, as well as an assessment of the manufacturer’s QMS. The MHRA will need to consider which regulatory approvals it could accept, and the appropriate level of domestic assurance required to accept the device onto the UK market. Domestic assurance would not be relevant for clients of EU Notified Bodies who also have designation as a UK Approved Body. Such clients could be offered a ‘CE plus UKCA’ route which would result in certification for both the UK and EU markets. All manufacturers who utilize the MDSAP or Domestic Assurance approach would need to register with MHRA and appoint a UK Responsible Person where they are based outside of the UK.

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Chapter 14: Alternative Routes to Market

On 21 May 2024, the MHRA issued a new statement of policy intent for recognition by the UK* of international regulators’ approvals of medical devices. The use of international regulatory approvals for medical devices will reduce the regulatory burden on manufacturers by reducing duplication and allow the MHRA to concentrate its focus on high-risk and innovative products. However, medical device manufacturers will still have the option to use the UKCA marking to place devices on the Great Britain market. The MHRA will retain the authority to reject applications using other regulatory approvals if the evidence provided is considered insufficiently robust. The comparable regulator countries (CRCs) for the proposed framework will be:

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