Post-Market Surveillance/ Post-Market Clinical Follow-up

In order to ensure safety and efficiency of the medical device after placing on the market, the Medical Device Regulation 2017/745 requires post-market surveillance (= PMS / Post-Market Surveillance). This includes all activities that medical device manufacturers must undertake, in collaboration with their economic operators, to establish a process for the proactive collection and revision of clinical experience of their medical devices and the requirement to keep this information up to date. This could identify any need for prompt corrective or preventive action. A key component of these post-market surveillance activities is the manufacturer’s proactive post-market clinical follow-up (PMCF). Although, it is not a new requirement in principle (as ISO 14971: 2012, ISO 13485: 2016 and also the MDD already require monitoring activities after placing the medical device on the market), the Medical Device Regulation 2017/745 increases the regulatory requirements for the scope and implementation of PMS – and PMCF activities, which inevitably leads to an increased documentary effort. It is therefore to be expected that more PMCF studies and user observations will be carried out in order to comply with the regulations.

PROSYSTEM GmbH has wide experience in the collection and analysis of clinical data with regard to the benefit-risk ratio and the documentation in corresponding reports.

Our services in the area of PMS and PMCF include:

  • Implementation of PMS & PMCF processes
    • Evaluation of the actual state
    • Identification and evaluation of interfaces
    • Update or preparing the processes regarding the Medical Device Regulation 2017/745
  • Preparation of PMS & PMCF activities
    • Creation or review of the PMS and / or PMCF plan
    • Execution and completion of PMS & PMCF activities
  • Support in the collection and evaluation of clinical data or continuous independent collection and evaluation of clinical data
  • Submission and communication with the Ethics Committee in conducting PMCF studies
  • Development of the PMCF study design
  • Continuous monitoring of databases and registers
  • Conducting the literature search
  • Statistical data evaluation
  • Final report in the form of a post-market clinical evaluation report
  • Seminars or workshops on post-market surveillance/li>
  • For further information regarding “PMS / PMCF” or for a quotation just contact us.