Clinical 1 – Clinical Evaluations: how to comply with MEDDEV 2.7/1

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Regulatory Affairs Professionals
• Engineering professionals
• Research/Development professionals
• Personnel involved in any aspect of the clinical evaluation process
• Quality Assurance Professionals

Course Outline

A Clinical Evaluation is not necessarily a Clinical Trial, or ‘Clinical Investigation’ to use the correct terminology; it is often a review of available literature carried out in a defined methodical and analytical way as defined within the guidance documentation available.

Most Medical Device manufacturers will have become aware that Notified Bodies are placing a much greater emphasis on Clinical Evaluations than ever before. This is due, in part to directive 2007/47/EC but also due to increasing regulatory emphasis brought about by bad press stories. Since the 2007 amendment to the Medical Device Directive came into force in March 2010 every medical device sold into Europe, irrespective of its classification, must have a clinical evaluation report as part of its technical file.

Clinical evaluations should remain active throughout the lifetime of the device and should be updated and reviewed as and when more clinical data becomes available – this emphasises the importance of building the report on solid foundations.

Many underestimate the task at hand and find it’s not until they start trying to collate the report that they find there is little available in terms of support and clear guidance. The purpose of this practical course is to demystify the clinical evaluation process and provide a structured and methodical approach for producing fully compliant clinical evaluations.

Topics covered

• An overview of clinical evaluations and their importance
• Identifying areas that require support from clinical data
• Research methodology
• Sources of data
• Analysis of data – screening and selecting
• When a clinical investigation is required
• Structuring and collating the report
• An understanding of what is required to successfully complete a clinical evaluation
• Where and how to source data
• An approach for selecting and screening data
• A structure on which clinical evaluations can be based

Outcomes

• An understanding of what is required to successfully complete a clinical evaluation
• Where and how to source data
• An approach for selecting and screening data
• A structure on which clinical evaluations can be based