Module 15 2022

20/05/2022

CEAR – Access to Date

Points to note: ● No escaping contract/access to data for equivalence. ● But for Class I, IIa and IIb non implantable devices: access to data can be manufacturer’s test data on the device. ● Class III and implants – The CEAR clearly requires evidence of the contract.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

11

CEAR – State of the Art

Points to note: ● Broad assessment of the SOTA. Medical field/condition, alternative treatments, similar devices. ● Used to set safety and performance endpoints. – What are the common measures used in the literature for these devices. ● Assessment criteria. – Set from benchmark data. – What is the benchmark? Is there a specific medical guidance (eg NICE), aggregate data from related devices, a single market leader. ● Confirm device remains SOTA. – Any guidance documents that confirm this

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

12

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