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Do you require additional data for your clinical evaluation?
Has the Notified Body revealed any deficiencies concerning your PMCF plan?
The long-term safety of your medical device is not yet sufficiently proven?
Are you looking for scientific support regarding clinical issues?
Do you need information on the lifetime of your implant?
Would you like to identify previously undetected side effects?
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. In this phase, we will exchange all necessary information.
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.
You have collected clinical data with your CE-marked product. We evaluate the data for you and complete the PMCF Evaluation Report by the desired date.
Would you like to acquire more knowledge? Our training is conducted by our experts and adapted to your needs, depending on the product, knowledge level of the employees, etc..
We thoroughly review your PMCF documentation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.