Efficient updating of the clinical evaluation: Creation of PMCF plan and PMCF evaluation report as well as monitoring of PMCF activities

Reduced effort for post-market clinical follow-up activities

The clinical evaluation must be regularly supplemented with new clinical data as part of market surveillance (post-market clinical follow-up, PMCF). In doing so, requirements from European laws and guidelines must be considered, which are tested by Notified Bodies.

With avaPMCF we provide you with templates for PMCF Plan and PMCF Evaluation Report as an extension to avaClinical, which are based on the requirements of MDCG Guidelines 2020-7/2020-8. The digital documentation makes it easy to reuse existing information from input documents, thus reducing the time and effort required to create them.

A central overview of planned PMCF activities in the company and a time monitoring system combined with email notifications ensure that no activity is forgotten. Results from PMCF activities are also centrally documented and managed. Customizable tables provide a user-friendly overview of information and

results are automatically inserted into the corresponding PMCF evaluation report, thus minimizing manual effort. Information from the PMCF Evaluation Report can be reused in the Clinical Evaluation Report as well as in the PMS Report or Periodic Safety Update Report (PSUR), thus reducing the time and effort required to create and update the PMCF Evaluation Report.

Linking PMCF information to content in the Clinical Evaluation Report and the Risk Management File illustrates the interdependency of information, allowing you to quickly see the impact of PMCF results on other elements of the Technical Documents.

Overview of features:
  • Templates for PMCF Plan and PMCF Evaluation Report, based on MDCG guidelines
  • Efficient template creation through reuse of existing information
  • Centralized management and monitoring of PMCF activities at product or company level
  • Automatic reminders regarding deadlines
  • Centralized collection of results of PMCF activities
  • Easily customizable LiveReport Pages tabular overview of information
  • Easily reusable information from the PMCF Evaluation Report to update the Clinical Evaluation Report and create the PMS Report/PSUR
  • Linking of information in the PMCF Plan and PMCF Evaluation Report with content from the clinical evaluation and risk management file
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Sarah Panten
Sarah Panten
Strategic Business Development