Module 16 2024

10/17/2024

Article 2 - Clinical Evidence, Evaluation and Data Scope and Definitions – Article 2 – Clinical Evidence

Clinical Evidence Art 2 (51 )

Clinical Evaluation Art 2 (44)

Clinical Data Art 2 (48)

• The clinical data and clinical evaluation report pertaining to a device • Sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer

• A systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device • To verify the safety and performance, including clinical benefit , of the device when used as intended by the manufacturer

• Clinical investigation on the device concerned • Clinical investigation reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated • Peer reviewed scientific literature on other clinical experience of either the device in question or a similar device for which equivalence can be demonstrated • Data from the manufacturer‘s post - market surveillance system, in particular post-market clinical follow- up

Courtesy of TUV SUD

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

43

43

Article 2 - Clinical Evidence, Evaluation and Data Scope and Definitions – Article 2 – Clinical Evidence

Clinical Evidence Art 2 (51 )

Clinical Evaluation Art 2 (44)

Clinical Data Art 2 (48)

• The clinical data and clinical evaluation report pertaining to a device • Sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer

• A systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device • To verify the safety and performance, including clinical benefit , of the device when used as intended by the manufacturer

• Clinical investigation on the device concerned • Clinical investigation reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated • Peer reviewed scientific literature on other clinical experience of either the device in question or a similar device for which equivalence can be demonstrated • Data from the manufacturer‘s

post- market surveillance system, in particular post market clinical follow- up

Courtesy of TUV SUD

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

44

44

22