Module 17 2024

05/12/2024

Chapter 5: Approved Bodies

c. Liability: The Approved Body shall take out appropriate liability insurance for its conformity assessment activities; the scope and overall financial value of the liability insurance should correspond to the level and geographic scope of activities of the Approved Body and be commensurate with the risk profile of the medical devices certified by the Approved Body d. Quality management: The Approved Body will establish, document, implement, maintain and operate a Quality Management System that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of the UK medical devices regulations e. Personnel (including requirements for personnel qualifications): The UK medical devices regulations will set out the minimum qualification requirements for personnel involved in medical device technical assessments and manufacturer QMS assessments

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Chapter 5: Approved Bodies

f. Process requirements: The Approved Bodies will have documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which they are designated. These procedures will comprise the individual steps from pre-application activities to decision-making and surveillance and will take into account, when necessary, the respective specificities of the medical devices. Experience from COVID Approved Bodies will be able to conduct fully remote or hybrid audits of their clients in specific circumstances. The circumstances in which hybrid or full remote audits are permitted to be undertaken should be genuinely disruptive/justified .

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