Module 15 2022

19/05/2022

Clinical Evaluation - definitions

MEDDEV 2.7.1 Rev.4

MDR 2017/745

a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

5

Clinical Data - definitions

MDR 2017/745

MDD/ MEDDEV 2.7.1 Rev.4

‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

Clinical data: the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from:

- clinical investigation(s) of the device concerned

- clinical investigation(s) of the device concerned;

- clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated - reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated - published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

6

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