According to the European Directive 93/42/EEC it is required “to actively update the CER with data obtained from the post-market surveillance” (Annex X 1.1.c)”, however neither the Directive nor the MEDDEV guidance document 2.7.1 provide information on a specific requirement regarding the time period for updating the clinical evaluation.
Active updating at regular intervals
The manufacturer needs to have a procedure for post-market surveillance in place defining how the MDD requirement to actively update the clinical evaluation is fulfilled. Depending on the device and its intended use the predefined period for a scheduled update of the CER may range between months and 5 years. (Note: More than 5 years will not be accepted, this correlates with the certificate’s period of validity).
It must be traceable, how post-market surveillance data (i.e. from PMCF, complaint analysis, AE databases, literature, customer surveys, conventions, etc.) are monitored to ensure that an unscheduled update of the CER is triggered by new market information on clinical safety and/or performance gained during the clinical usage of the device.
PMS documentation will be reviewed by the Notified Body e.g. during audits (as part of the TF review) and/or in the context of the assessment of certificate extensions, change notifications, vigilance cases, etc.
For any new device design dossier submission or clinically relevant change notification (even if the certificate is not affected) or during extension of a product certificate the CER needs to be updated to reflect the current clinical evidence. TÜV SÜD only accepts CERs not dating back further than 6 months prior to submission/1 year prior to the expiration date of the certificate, i.e. the updated CER shall then contain the most recent available clinical data from scientific literature and post-market surveillance.