PMS: An Efficient Process for Practicality and Added Value
April 11, 2023
Post-Market Surveillance (PMS) for medical devices should be understood as an overarching process with numerous interfaces. However, only an efficient process ensures practicality and adds value for the company.
PMS: Post-Market Surveillance of Medical Devices
For each product, a system for PMS must be:
- planned,
- established,
- documented,
- implemented, and
- maintained
The goal of the PMS system is to actively and systematically collect, record, and analyze meaningful data on the quality, performance, and safety of the medical device throughout its lifecycle, as well as to initiate and monitor the necessary preventive or corrective actions.
The new Medical Device Regulation (MDR) tightens the requirements for PMS of medical devices, placing significantly greater emphasis on the collection of clinical data. Clinical data must also be collected and evaluated by the manufacturer as part of post-market clinical follow-up (PMCF). Additionally, there is a focus on proactive data collection and interpretation. Unfortunately, the legal framework does not clearly differentiate between proactive and reactive actions.
Interfaces of the PMS Process
The PMS system has interfaces with the following processes:
- Risk management
- Manufacturing and labeling
- Clinical evaluation
- CAPA and FSCA
- Usability
- Technical documentation
Challenges in PMS and Vigilance of Medical Devices – Are You Familiar with These?
Aligning terms like PMS, PMCF, and PSUR can be challenging. Installing an appropriate system for PMS of medical devices can be difficult because:
- The system has interfaces with numerous other processes within the company
- PMS activities must be carefully planned
- Findings and actions must be documented in a corresponding report for each product or product group.
Moving on to the topic of vigilance:
- When does a serious incident occur?
- What safety corrective action is appropriate?
- What deadlines and criteria apply for reporting to the authority?
Vigilance for Medical Devices – The Medical Device Monitoring and Reporting System
The reporting timeframe for incidents has changed with the MDR. As before, serious incidents and safety corrective actions must be reported to the competent authorities within specified timeframes. Serious incidents are still defined as those resulting in death, deterioration of a person's health, or a risk to public health, or that could have resulted in these outcomes.
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