GMED Guide - Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) Regulation (EU) 2017/745 - March 2022 Edition

Sep 13, 2026

GMED’s guide explains key regulatory concepts for medical devices clinical evaluation under the EU 2017/745 framework, centered on the Summary of Safety and Clinical Performance (SSCP). It consolidates reference materials, including EU regulations and MDCG/MEDDEV guidance, and provides definitions such as bias, clinical data, clinical evaluation, and clinical evidence. It supports manufacturers and notified bodies by structuring the clinical evaluation approach, including principles, equivalence, and planning outputs like the Clinical Evaluation Report (CER).

LanguageEnglish

CategoryGeneral

FormatPDF

Pages26

Reading Time9 min

AccessFree to download

Contents

I Reference documents

II Definitions

III Part A: Clinical evaluation

IV Part B: Summary of safety and clinical performance

Annex 1

GUIDE MEDICAL DEVICES CLINICAL EVALUATION SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745 MARCH 2022 EDITION GMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022 MEDICAL DEVICES CLINICAL EVALUATION SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745 MARCH 2022 EDITION CONTENTS I REFERENCE DOCUMENTS 3 II DEFINITIONS 4 III PART A: CLINICAL EVALUATION 6 1 Principles of clinical evaluation 6 2 Equivalence 11 3 Clinical evaluation plan 14 4 Clinical Evaluation Report (CER) 15 IV PART B: SUMMARY OF SAFETY AND CLINICAL PERFORMANCE 24 ANNEX 1 25 GMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022 MARCH 2022 EDITION MEDICAL DEVICES CLINICAL EVALUATION SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745 I REFERENCE DOCUMENTS NOTE The European Regulation is published in the Official Journal of the European Union. MEDDEV guidelines are available on the European Commission website: [https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en](https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en)[ ](https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en)[MDCG guidelines are available on the European Commission website:](MDCG guidelines are available on the European Commission website:)[ ](MDCG guidelines are available on the European Commission website:)[https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en](https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en)[ ](https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en)[Standards are available at AFNOR www.afnor.org](Standards are available at AFNOR www.afnor.org) GHTF (Global Harmonization Task Force) guidelines are available on the following website: [http://www.imdrf.org/documents/documents.asp](http://www.imdrf.org/documents/documents.asp) GMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022 | ORIGIN | REFERENCE | TITLE | | --- | --- | --- | | European
Union | Regulation (EU) 2017/745 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC | | European Union | MEDDEV 2.7/1 rev.4 | Evaluation of clinical data: a guide for manufacturers and notified bodies | | European Union | MEDDEV 2.12/2 rev.2 | Guidelines on post-market clinical follow-up | | CEN-ISO | NF EN ISO 13485: 2016 | Medical devices
Quality management systems – Requirements for regulatory purposes | | CEN-ISO | NF EN ISO 14971: 2013 | Medical devices – Application of risk management to medical devices. | | CEN-ISO | NF EN ISO 14155: 2012 | Clinical investigation of medical devices for human subjects | | GHTF | SG5/N1R8 (2007) | Clinical Evidence – Key definitions and concepts | | GHTF | SG5/N2R8 (2007) | Clinical Evaluation | | MDCG | MDCG 2019-9 | Summary of safety and clinical performance
A guide for manufacturers and notified bodies | | MDCG | MDCG 2020-1 | Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software | | MDCG | MDCG 2020-5 | Clinical evaluation – Equivalence
A guide for manufacturers and notified bodies | | MDCG | MDCG 2020-6 | Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EECA guide for manufacturers and notified bodies | | MDCG | MDCG 2020-7 | Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies | | MDCG | MDCG 2020-8 | Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies | | MDCG | MDCG 2020-13 | Clinical evaluation assessment report template | | MDCG | MDCG 2021-20 |

FAQs

What is bias in the context of medical device clinical evaluation?

Bias is a systematic deviation of an outcome measure from its true value, which can overestimate or underestimate a treatment effect. It can come from patient allocation, outcome measurement/interpretation, and data recording/reporting practices.

What qualifies as clinical data for medical device evaluation?

Clinical data includes safety or performance information generated from device use, sourced from clinical investigations, scientific literature where equivalence can be demonstrated, peer-reviewed reports on relevant clinical experience, and clinically relevant post-market surveillance data, especially post-market clinical follow-up.

How is clinical evaluation defined under EU 2017/745?

Clinical evaluation is a systematic and planned process that continuously generates, collects, analyzes, and assesses clinical data to verify device safety and performance, including clinical benefits, when used as intended by the manufacturer.

Sep 13, 2026

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