Clinical Evaluation Reports for EU-Marketed Medical Devices – A Summary of the Regulatory Guidance

Following the June 2016 release of the new MEDDEV 2.7/1, revision 4 guidance (Rev 4), manufacturers of CE-marked medical devices are scrambling to maintain compliance. Clinical evaluation is necessary for the initial CE-marking of new devices, as well as for devices that have been marketed for years. Manufacturers are required to provide sufficient evidence to show conformity of the medical device to the Essential Requirements, and its performance and safety when used clinically according to the instructions for use. Clinical Evaluation Reports (CERs) must be created during device development and updated periodically throughout the marketed lifetime of the device in the EU. This summary outlines the major aspects of this regulatory requirement. Rev 4 specifies the required steps to perform a robust clinical evaluation, which include; defining the scope of the evaluation, systematically identifying and analyzing the available clinical data, and reporting the results of the evaluation. The scope of the evaluation takes into consideration the disease state and progression, target user populations, current “state of the art” of the available treatment options, as well as the known benefits and risks of using the device, and any gaps in knowledge. Clinical evaluation is based on data from clinical investigations or a literature review, although a combination of both data sources is commonly used in practice. During development of new medical devices, a gap analysis defines what data is needed to demonstrate conformity, and any necessary clinical investigations should be incorporated into the overall development plan. For currently-marketed devices, any clinical data obtained during development as well as post-market surveillance data can be used. The safety and performance of a...