To ensure safety and performance even after placing a product on the market, post-market surveillance (PMS) is a regulatory requirement.

Reactive and Proactive Collection of Empirical Data for Medical Devices

The PMS includes all activities that medical device manufacturers must undertake in collaboration with their economic operators to set up and maintain a process for the reactive and proactive collection and review of their medical device experience. The aim is to identify any need for corrective or preventive action to be taken immediately and to act accordingly. In principle, this is not a new requirement in the Regulation (EU) 2017/745 (MDR, Medical Devices Regulation) because DIN EN ISO 14971:2012, ISO 13485:2016 and Directive 93/42/EC (MDD, medical devices directive) already called for post-market surveillance activities. However, the Medical Device Regulation increases the demands on the scope and implementation of PMS activities, which inevitably entails an increased documentary effort.

Clinical Follow-Up as Part of Proactive Post-market Surveillance

A key component of post-market surveillance activities is the manufacturer’s post-market clinical follow-up (PMCF). Regarding the increased demands on the PMS described above, it is expected that more PMCF studies and usability activities will be carried out in order to comply with the regulations.

Do you need support in monitoring your products in the market? We have many years of experience in the development of PMS systems, including preparing post-market surveillance plans. Our experts provide information on the collection and analysis of clinical data regarding the benefit-risk ratio and advise on dealing with incidents and safety corrective measures in the field. As part of medical writing, we document your empirical data in corresponding reports.

PMS and PMCF services:

  • Implementing PMS/PMCF processes
    • Evaluating the current status and identification of gaps regarding the benefit-risk ratio
    • Identifying and evaluating interfaces
    • Updating or preparing the processes regarding the Medical Device Regulation (EU) 2017/745
  • Preparing PMS and PMCF activities
    • Creating or reviewing the PMS and/or PMCF plan
  • Executing and completing PMS and PMCF activities
    • Supporting the collection and evaluation of clinical data or continuous autonomous collection and evaluation of clinical data
    • Submission and communication with the ethics committee in conducting PMCF studies
    • Developing the PMCF study design
    • Continuously monitoring databases and registers
    • Carrying out the literature search
    • Statistical data evaluation
    • Final post-market surveillance report (PMSR, post-market surveillance reports pursuant to Article 85 of (EU) 2017/745)
    • Creating and regularly updating safety reports, including the periodic safety update report (PSUR) in accordance with Article 86 of (EU) 2017/745
  • Seminars or workshops on post-market surveillance
  • For more information on post-market surveillance or post-market clinical follow-up or for a quote please contact us.