Module 15 Presentations

10/04/2024

CEAR – Access to Data

Points to note: ● 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 states a requirement of evidence of a contract. This has been superseded by MDCG 2023-7 (Sec 5). A contract is only required for Class III and implantable under Article 61(5). ● *MDCG 2023-7 includes Class III and implantable under Article 61 (6a and 6b) in this category.

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