Module 17 2024

05/12/2024

Chapter 6: Conformity Assessment

Voluntary change of Approved Body In cases where a manufacturer voluntarily moves to another Approved Body concerning the conformity assessment of the same medical device, the new regulations will set out the minimum content that should be included in an agreement between the manufacturer, the incoming Approved Body, and, where practicable, the outgoing Approved Body. However, no specific details have been documented in the consultation document. Declaration of Conformity The minimum content of Declarations of Conformity will be detailed within the regulations

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Chapter 7: Clinical Investigations

Clinical evaluation (general medical devices) The regulation will introduce new requirements on entire equivalence on a biological, technical, and clinical basis. This approach would go beyond the equivalence requirements in the EU MDR. The MHRA will provide clear and detailed guidance on this topic in the future. The regulations will also introduce clinical investigation requirements for products with similar functions and risk profiles to medical devices that do not have an intended medical purpose. The MHRA will provide supplementary guidance on these requirements in the future.

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