Clinical Evaluation for Medical Devices in Development

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Clinical Evaluation Sample page

Quick Overview


This Standard Operating Procedure (SOP) describes the individual steps and process necessary to comply with the Clinical Evaluation for medical devices. This SOP applies to all Medical Devices under development after concept and feasibility studies are completed.

Demonstration of conformity is requested by the Council Directive 93/42/ECC, Annex I, with the relevant essential requirements, which include a clinical evaluation in accordance with Annex X.

Clinical Evaluation for Medical Devices in Development

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  • Clinical Evaluation for Medical Devices in Development




The objective of this SOP is to describe the pre-market clinical evaluation process of medical devices.

This SOP describes how the clinical evaluation is conducted according to MEDDEV 2.7.1, guideline for clinical evaluation.

All activities relevant for the conduct of a clinical investigation according ISO 14155 are not part of this SOP.


Regulatory basis, reference documents´╗┐


  • MEDDEV2.7.1/Rev.3 : Guideline on medical devices: Clinical evaluation – a guide for manufactures and notified bodies
  • EN ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good clinical practice
  • Directive 93/42/EEC: Council Directive 93/42/EEC and amendments
  • EN ISO 14971 Medical devices – application for risk management to medical devices


Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Head and Department

4.3       Medical Scientist

5          Related documents

6          Definitions

7          Procedure

7.1       Introduction to Clinical Evaluation

7.2       General

7.3       Process

7.3.1    Definition of Scope

7.3.2    Essential Requirements

7.3.3    Literature Search

7.3.4    Clinical Experience Data

7.3.5    Clinical Investigations

7.3.6    Analysis of Clinical Data

7.3.7    Conclusion and Report

8          Attachments

9          SOP distribution

10        Health, safety and environmental considerations



Size and Format:


    Microsoft Office 2003

    Word File

    10 pages procedure

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