Post-market surveillance of Medical Devices is an integral part of the European conformity assessment procedure. However, not all manufacturers know which post-market data must be included in the clinical evaluation report (CER) to ensure smooth and fast assessment of this document.
Today's requirements for post-market surveillance are based on the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). Since the revision of the European Medical Devices Directive, post-market surveillance – and thus post-market clinical follow-up (PMCF) – are mandatory elements of the manufacturer's quality management system. Most manufacturers have extensive experience in the documentation of post-market data. Nevertheless, incomplete documentation often makes conformity assessment more difficult. Our checklist summarises the minimum data that must be included in the regular documentation.
The right approach is important
Separate clinical data must be collected for each model in a device family. Clinical data may not refer to the device family as a whole. They can be included either in the clinical evaluation itself or added in an annex thereto. The documentation must further justify why the number of complaints is within acceptable limits. If one of the required criteria is not applicable to the Medical Device under investigation, this fact must be stated explicitly in the documentation.
Checklist for post-market data
Current data from the latest regular post-market surveillance activities and/or clinical follow-up studies of the device:
Number of devices sold
Number and type of complaints
Number and type of reportable events to competent authorities
Number and type of corrective and preventive actions
Number and type of field safety corrective actions (FSCAs)