Do you have sufficient clinical evidence for your medical device?

The revised European guideline on clinical evaluation is a stepping stone to meeting the impending regulations

The current Medical Device Directives place responsibility on the manufacturer to update and maintain clinical evidence for their devices. In June 2016, a revision of Med Dev 2.7/1 on clinical evaluation was issued (MEDDEV 2.7/1 revision 4 – June 2016 - Guidelines on Medical Devices – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC). This revision is longer and more detailed than the previous version. It provides guidance and examples to clarify understanding of current expectations in meeting the Medical Device Directives.

Notified Bodies are now assessing applications for new certificates, renewals and changes that affect the clinical evaluation against this new version. You need to understand the changes, how they affect the clinical evidence that supports your devices and have a plan to ensure that your documentation becomes fully compliant.

This Med Dev guidance also provides a preview of some of the expectations in the imminent Medical Devices Regulation (MDR). Compliance with this Med Dev is a step in a comprehensive plan to get to transition to the new MDR. However, Med Dev 2.7/1 Rev 4 and the Medical Devices Regulation diverge in some areas so there will be more that you have to do to be compliant with the new MDR. One example is in the access to clinical data for devices with which equivalence is claimed. Familiarity and knowledge of both the revised guidance and the MDR, and in particular the differences between them, is important for planning the transition to the MDR. You need to identify where you have gaps in your clinical evidence that you might need to fill in order to CE mark a device under the new MDR. Gathering clinical evidence will drive the timeline for some activities in MDR transition. It will also be a significant contributor to the cost of this transition if new clinical evidence needs to be generated.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.