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Clinical Evaluation Template

All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use. This template could be used in order to complete: the clinical investigation plan the clinical investigation report the clinical investigation application form the Investigator’s Brochure. As per the requirements under the new EU Medical Device Regulation 2017/745

All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.

This template could be used in order to complete:

the clinical investigation plan
the clinical investigation report
the clinical investigation application form
the Investigator’s Brochure.

As per the requirements under the new EU Medical Device Regulation 2017/745

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Document ID: #<br />

Revision No.: #<br />

Effective Date:<br />

<br />

Table of Contents<br />

1.0 Introduction ................................................................................................................ 3<br />

2.0 Key Objectives ............................................................................................................ 4<br />

3.0 Responsibilities ........................................................................................................... 4<br />

4.0 Procedures .................................................................................................................. 5<br />

4.1 <strong>Clinical</strong> <strong>Evaluation</strong> Plan ....................................................................................................... 5<br />

4.2 <strong>Clinical</strong> <strong>Evaluation</strong> Process .................................................................................................. 7<br />

4.3 <strong>Clinical</strong> <strong>Evaluation</strong> Report ................................................................................................... 8<br />

4.4 Application Form for <strong>Clinical</strong> Investigation........................................................................... 8<br />

4.5 Investigator’s Brochure ..................................................................................................... 11<br />

4.6 <strong>Clinical</strong> Investigational Plan ............................................................................................... 13<br />

4.7 <strong>Clinical</strong> Investigational Report ........................................................................................... 19<br />

Red text = needs to be changed and write the information of the product<br />

Grey text = add the text if it’s necessary according to the needs of product<br />

Blue text = the context needs to be added by the responsible body

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