PMCF – POST MARKET
CLINICAL
FOLLOW-UP
YOUR TASK
You monitor and analyze the use of your medical device in order extend the range of clinical data available to continuously improve the evaluation of your device’s performance and also identify unknown risks.
YOUR NEEDS
We focus on your demands.
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?
YOUR BENEFITS
We are happy to work according to your SOPs/templates. Alternatively, we use our own templates. These have been developed based on the requirements of Regulation (EU) 2017/745 and MDCG 2020-7 and MDCG 2020-8 and are continuously optimized based on new findings.
PMCF AT A GLANCE
Depending on your needs, our PMCF activities are either integrated with clinical assessment activities or run hand-in-hand with the PMS system. They include the following work steps.
1
Projekt Kick-off
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.
2
PMCF Plan (MDCG 2020-7)
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.
3
Planning of PMCF activities
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.
4
Data identification
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.
5
Data assessment
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.
6
Data analysis
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.
7
PMCF-Plan (MDCG 2020-8)
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.
Get in touch with our experts!
Do you have any further requests?
Regular PMCF Updates
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.
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Training
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..
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GAP Analysis
We thoroughly review your PMCF documentation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.
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