New Revision to the Guidance on Clinical Evaluation Reports

Updated Guidance on the Preparation of Clinical Evaluation Reports

The European Union recently released an updated guidance for the completion of Clinical Evaluation Reports (MEDDEV 2.7.1 Rev. 4, June 2016) entitled, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. This guidance updates Rev 3, which was issued in December 2009, and it is an attempt to provide a more proscriptive and rigorous approach to the content of the Clinical Evaluation Report. Throughout the document, it is expected that the manufacturer make explicit links between the Clinical Evaluation Report and supporting materials such as the Instructions for Use, and between the Clinical Evaluation Report and the Essential Requirements. Some of the more significant revisions include the following:

  • A section was added to the Clinical Evaluation Report that defines the planning and scope of the evaluation.
  • The guidance requires that, in the report, the manufacturer explicitly states the frequency at which their clinical evaluation report will be updated. This frequency should reflect the risk associated with the product.
  • A section was added where the manufacturer must explicitly address how its device embodies the state of the art. In this section, manufacturers must describe the clinical condition the device is intended to address and the range of treatment options available. This section has its own literature search with predefined search strategy and literature appraisal criteria.
  • If a manufacturer claims equivalence to another device on the market, the revised guidance requires that it more extensively and explicitly demonstrates its device’s equivalence than what was previously required. Equivalence must be demonstrated not only for the technological components, but also for the entirety of the clinical indications and usages, including intended populations. Equivalence must be based on a single device. Note that equivalence in adult populations does not necessarily mean equivalence to pediatric populations.
  • The guidance requires that manufacturers take a more expansive and critical approach to the appraisal of data quality. The guidance provides suggested expansions to the criteria for data quality appraisal.
  • The guidance requires a more extensive discussion of the risk/benefit profile of the device.

The guidance provides a checklist against which manufacturers can review their clinical evaluation reports, prior to releasing their reports. It is highly recommended that manufacturers incorporate this checklist into their standard operating procedures for the preparation of clinical evaluation reports.

In addition, manufacturers must keep on file – but not necessarily submit – a specific document from each author and/or evaluator declaring their potential conflicts of interest. This declaration must include their spouses, significant others, immediate family, and/or additional adults for whom the author/evaluator is responsible.

Gordon MacFarlane, PhD, RAC