27 July 2023

MDR (EU) 2017/745 describes and elaborates on the structure and minimum content of the Post-Market Surveillance Plan (PMSP) previously only mentioned in MDD 93/42/EEC as amended.

MDR (EU) 2017/745 in Annex III requires Manufacturers to have a systematic Post-Market Surveillance (PMS) procedure, including a Plan, to be applied to the organization and related to each device and/or device family.

Specifically, the Manufacturer must implement, for each Medical Device, a post-marketing surveillance system that collects, records, and analyzes data on the quality, performance, and safety of the device.

The data collected must be used to:

  • update the risk and benefit assessment;
  • update design and manufacturing information, instructions for use and labelling;
  • updating the clinical assessment;
  • update the safety and clinical performance summary;
  • identify the needs for preventive and corrective actions;
  • contribute to postmarket surveillance of other devices;
  • identify and report trends.

The post-market surveillance system should be part of the Quality Management System and should be continuously updated.

Article 84 MDR stipulates that the post-market surveillance system must be based on a post-market surveillance plan (PMSP), the requirements of which are defined in Annex III and which must be part of the technical documentation in Annex II.

Annex.III item I, precisely, defines the essential contents of the PMS plan are:

  • Data on serious incidents including information from PSURs and corrective safety actions in the field;
  • Information on nonserious incidents and data on possible side effects;
  • Trend reports;
  • Complaints provided by users Distributors and Importers;
  • Data regarding similar Medical Devices.

1- POST-MARKET CLINICAL FOLLOW UP PLAN (PMCFP)

The post-market surveillance (PMS) process must, among other things, include di and a Post-Market Clinical Follow Up (PMCFP) plan or a reason why the process is not applicable.

The clinical evaluation process consisting of continuous generation, collection, analysis, and evaluation of clinical data must verify the safety, performance, and clinical benefit of a Medical Device, is directly linked with the post-market surveillance system, and must include the post-market clinical follow-up process (PMCF).

PMCF is precisely defined as an ongoing process that updates the clinical evaluation and is addressed in the manufacturer’s postmarket surveillance plan. In carrying out the PMCF, the Manufacturer proactively collects and evaluates clinical data related to the use in or on humans of a device that bears the CE mark and is placed on the market or put into service within the limits of the intended use specified in the relevant conformity assessment procedure, in order to confirm the safety and performance throughout the intended life of the device, to ensure the unchanged acceptability of identified risks, and to detect emerging risks based on factual evidence (Annex XIV Part B).

For the application of the PMCF process, the same annex requires the Manufacturer to establish a documented method in a Post-Market Clinical Follow UP (PMCFP) plan by establishing its minimum content requirements.

>>> You are struggling with the preparation of the PMS?

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For the demonstration of the implementation of the post-market surveillance process, regulatory bodies require the submission of related plans, and it is not easy to define an appropriate document structure and content.

THEMA can make it easier and faster to prepare the PMSP by providing you with a template that is already “ready to use,” and validated by a long and solid experience in the field and implementation of MDR (EU) 2017/745.

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Let’s take care beyond the boundaries.