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Clinical Evaluation Plan

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Guest user Created:   Oct 29, 2021 Last commented:   Nov 02, 2021

Clinical Evaluation Plan

I have a task to complete to comply with MDR. My first priority is to write up a Clinical Eval Plan and then get it approved before starting the evaluation process. Question is what is a typical format would you recommend to use? This would be a Class 1 non invasive medical device that will be distributed in European countries.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Nov 02, 2021

We at Advisera recommend the Clinical evaluation plan as it is in our Documentation toolkit. The Clinical evaluation plan template is designed in accordance with the requirements stated in the MDR, Article 61 and Annex 14, and MEDDEV 2.7.1, rev 4. 

Consider the fact that both the Clinical evaluation plan and the Clinical valuation report should be documents that can be read independently, so all relevant information should be there - a complete description of the product, all its characteristics, indications, contraindications, risks, etc. - for the auditor to understand completely what kind of product it is without looking at other documents from the Technical Documentation. 

According to the MDR, documents from the domain of clinical evaluation are checked by another auditor, and not by the one who conducts the audit directly with a manufacturer.

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Oct 29, 2021

Nov 02, 2021

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