Efficient process for practicability and added value
Post-Market Surveillance is to be understood as a comprehensive process with numerous interfaces. Only an efficient process ensures practicability and added value for the company.
Post-Market Surveillance (PMS) - Surveillance after placing Medical Devices on the market
For every product, a post-market monitoring system must be planned, documented, applied, and kept in good condition.
The aim is to use this system to consistently collect and actively, record and analyze informative data on the quality, performance, and safety of the product during its service life and to initiate and monitor the necessary preventive or corrective measures.
The new Medical Device Regulation (MDR) tightens requirements for post-marketing surveillance and significantly increases the focus on the collection of clinical data. This is because clinical data must also be collected and evaluated by the manufacturer as part of post-market clinical follow-up (PMCF). Also, the focus is on proactive collection and interpretation. Unfortunately, the exact difference between proactive and reactive action is not clearly explained in the legal situation.
Interfaces of the Post-Market Surveillance process
The PMS system has process interfaces that are responsible for
- Risk Management
- Production and labeling
- Clinical Evaluation
- CAPA measures and FSCA
- Technical Documentation
Challenges in Post-Market Surveillance and Vigilance of Medical Devices - Are you also familiar with this?
PMS, PMCF, PSUR. As difficult as it is to align these terms, installing an appropriate Post-Market Surveillance system has its own challenges such as:
- The system has many interfaces to other processes in your company
- Post-Market Surveillance activities must be planned
- The evidence and actions are to be filed in a report for each product or product group.
The topic of vigilance continues:
- How long before a serious incident occurs?
- What corrective security measure is appropriate
- What are the deadlines and criteria for reporting to the authorities?
Vigilance for Medical Devices - the Medical Device monitoring and reporting system
In the MDR the deadline for reporting incidents has changed. As before, serious incidents and safety corrective measures must be reported to the responsible authorities within specified deadlines. As previously, serious incidents are those that could have or have resulted in death, serious deterioration of a person's state of health, or serious public health threat.
It is also necessary to report statistically significant increases in the frequency or severity of NON-serious events that significantly affect the previous benefit-risk assessment of the product or product group. The PMS plan shall specify the method by which "significant increases" are identified.