GMED North America’s Training Center

Clinical Investigation of Medical Devices

Identify, appraise and analyze available clinical data from relevant scientific literature on a medical device 

1-day training session | Virtual Classroom

Next Training Date May 20, 2026 , Training | Virtual Classroom

About the training

All medical devices marketed in Europe and UK must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. However, despite the CER being essential, there continues to be a lack of clarity regarding key requirements and best practices for creating these reports. Without a clear understanding of what is required, both manufacturers and Notified Bodies (NBs) struggle to apply a consistent approach to the CER process.

Now that the new Medical Device Regulation (EU) 2017/745 has come into force in the European Union, there is an even greater emphasis on providing high quality, relevant, supporting clinical data, combined with the need to plan CERs and fully document the approach and processes around it.

A critical evaluation of the relevant scientific literature is one essential element of the CER. For many medical devices it is the main, or only, source of relevant clinical data. For many medical devices this will require at least two systematic reviews of literature in every CER. This course will cover why, when and how to undertake this systematic scientific process.

REQUIRED LEVEL

Familiarity with scientific publication elements such as scientific journals, articles and referencing.
Some familiarity with clinically relevant parts of some of EU MDR 2017/745, UK MDR 2002, Directive 93/42/EEC and 90/385/EEC. Especially Article 61 and Annex XIV of 2017/745 and related guidance such as MEDDEV 2.7/1 rev4.

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Field Expereinced Reviewer

Who Should Attend

Clinical evaluators in medical device manufacturers and consultancy
Medical writers and editors with an interest in medical devices
Researchers planning and conducting clinical investigations of medical devices
Reviewers and assessors of clinical evaluations at Notified Bodies and regulatory authorities
Regulatory affairs and quality managers

Learning Objectives

To understand why and when systematic literature review is needed during a device lifecycle
To be able to formulate a scientific question that defines the scope and purpose of a literature review
To identify sources of literature and how to use them
Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management
To understand the main validated systematic review methods and tools to be able to select the correct combination for your situation