To begin with, we define the strategic approach for your PMCF activities based on the clinical evaluation and agree on appropriate timeframes, including any deadlines that need to be met. The exchange of all necessary information takes place.
The PMCF Plan (PMCFP) for Conformity Assessment (CE Marking) is prepared, based on the MDCG 2020-7 and the results of the CER. In doing so, we remain cost effective – keeping an eye on generating relevant data only. Depending on the lifecycle phase, we also update your existing PMCFP.
There is detailed planning of individual PMCF activities according to the PMCFP including PMCF studies, PMCF surveys, literature research and evaluation, registry evaluations, including the preparation and implementation of PMCF studies and PMCF surveys.
Data identification, including documentation of database search activities, will be conducted and continuously updated in close association with PMS and clinical evaluation. Data from PMCF studies and surveys will be compiled.
In coordination with Clinical Assessment, including data extraction from scientific publications and that of Quality Assessment (e.g., by Level of Evidence), an assessment of the collected data is performed. Data on the safety and performance of the medical device are also evaluated.
The data are analysed in terms of clinical evaluation activities, relevant general safety and performance requirements (GSPRs). Subsequently the 'body of evidence' sums up everything about product under investigation.
Finally the PMCF Evaluation Report (PMCFR) based on MDCG 2020-8, or the annual update thereof, is released. It summarises the status quo of PMCF activities and provides input for clinical evaluation – ultimately also providing the SSCP for implantable medical devices and class III medical devices.