This is a brief overview of the most important points regarding Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).
Post Market Survey (PMS) Definition
PMS (Post Market Survey) refers to all activities carried out by manufacturers, in collaboration with other Economic Operators*, to establish and keep up to date a systematic proactive data collection procedure on their devices placed on the market, made available on the market, or put into service in order to take stock of their use; with the aim of identifying any need to immediately apply a preventive or corrective measure.
The PMS system must be planned, established, documented, implemented, maintained, and updated by the manufacturer, for each device, taking into account the risk class of the device, and it must be part of the manufacturer’s quality management system.
Schematic version of PMS:
1.Post-Marketing Surveillance Plan:
- Determination of proactive and reactive actions.
- Definition of the method to collect the data.
- Definition of the method to analyze the data.
- Limits and indicators.
2. Data implementation
Collect all the information concerning:
- Adverse effects.
- Trend report.
- Post-marketing clinical follow-up.
- Data from the literature.
- Data of competing products.
3. Data analysis, information, and regulatory action (periodic action):
All data collected is analyzed and, if necessary, the decision to inform the competent authorities is made.
4. Monitoring and evaluation
- Post-Market Surveillance performance measurement.
- Performance and safety assessment.
The implementation of the post-market surveillance plan can lead to 3 different reports depending on the class of the device:
- Post-Marketing Surveillance Report
- Periodic Safety Update Report (PSUR)
- Summary of safety and clinical performance (SSCP).
6. General communication
- Internal communication and management review.
- External communication: notified body, competent authority, EUDAMED.
In addition to the three directly linked reports, the PMS data allows to:
- Update the Clinical Evaluation Report (CER) or the Performance Evaluation Report (PER),
- Detect and report trends and thus update the determination of the benefit / risk ratio,
- Identify the possibilities for improvements (ease of use, performance, and security of the device), and thus update information on design and manufacture, instructions for use and labeling,
- Identify the need for corrective security measures (CAPA or FSCA) and thus improve risk management.
The PMCF is included in the PMS
Within the framework of this PMS system, PMCF (Post-Marketing Clinical Follow-up) activities are considered as a continuous process of updating the CER and thus, the PMCF plan is an integral part of the PMS plan.
The PMCF, a clinical follow-up after CE marking, consists of collecting clinical data in real life, to confirm the clinical data already present in the clinical evaluation or CER regarding performance and safety claims of a medical device.
How to update the PMCF:
Several ways to update clinical data should be considered, including:
- Systematic review of materiovigilance
- Bibliography update:
- On the concerned medical device
- On similar medical devices (be careful with equivalence)
- On therapeutic alternatives
- Active collection of clinical data in the context of clinical follw-up: A PMCF study
Implementation of a PMCF study is imperative when the device is associated with a high risk for the patient or when clinical data is not complete:
- Available clinical data does not cover the lifetime of the device.
- Clinical data can’t be extrapolated to the entire targeted population.
- There are unchecked clinical risks in the risk analysis.
If you need assistance to implement your PMS and/or your PMCF, do not hesitate to contact me.
*Economic Operators: Economic Operators are defined in the MDR as, the manufacturer, the Importer, the Distributor, and the Authorised Representative.