Medical Device Post Market Surveillance is normally performed after the medical device is released in market with CE Mark affixed on the device. Is the statement correct?
What is the relevance of Post Market Surveillance in CE Marking of Medical Device?
I disagree with the first statement. First of all, one needs to understand that the Post Market Surveillance is an integral part of the manufacturer’s Quality Management System (ISO 13485), where active and systematic gathering, recording and analysis of relevant data on quality, safety and performance of a device throughout its entire lifetime must happen, irrespective of the fact that it is CE marked or not! It helps manufacturers to draw up necessary conclusions and to determine, implement, and monitor any preventive and corrective actions. The PMS should be planned, established, documented, implemented, and updated, proportionate to the risk class and appropriate type of the device.
It must be noted that one of the PMS sources – Post Market Clinical Follow-up (PMCF), is normally performed after the medical device is CE marked.
The relevance of PMS in CE marking is that the relevant data on quality, performance, and safety of the device, gathered, recorded, and analyzed during the PMS are required for updating the technical documentation based on MDD/AIMDD/MDR. The technical file itself, the risk management file, the clinical evaluation report, the SSCP, Usability reports, etc. are to be updated based on the PMS data. The EU MDR 2017/745 has increased the focus on PMS activities as it ensures the marketing of safe and effective medical devices to the EU markets. With more PMS data, more evidence on the medical device could be collected so that unsafe medical devices will stay less likely in the EU market, thereby improving the quality of treatment of the European population.
I agree to the previous comment.
PMS is critical to generate data regarding the medical device that may identify rare events and incidents which were not previously identified. It also brings forth the advantages specific to your medical device, which improve its competitive edge. The PMS data is obtained from reactive sources and proactive sources. Reactive data is obtained when some complaint or problem occurs and proactive data is obtained through steps taken by manufacturer before any problem arises.
As mentioned in the comment above, PMS needs to be conducted irrespective of the CE mark. The medical device may already be available in the market at other locations. The PMS data collected from these markets can be used for establishing the conformity to safety and performance requirements, and benefits of the medical device during the CE marking. This is especially useful if there are unanswered questions or uncertainties or residual risks that could not be addressed using the data from the manufacturer or from the available literature.
PMS is a systematic and proactive process, carried out by the manufacturers with other economic organizations to take corrective and preventive actions as per the information collected about their medical device’s safety and performance.
It should be part of manufacturer’s quality management system and based on PMS plan.
PMS data is used to update the
• Technical documentation
• Risk management
• Usability reports
• SSCPs
• Clinical evaluation
PMS is performed after the device released in market not specifically with CE mark affixed to device.
CE mark represents device launch in the EU market.
So PMS data of device launched in other markets can be used to update the Clinical evaluation and prove its safety and performance requirements in absence of sufficient clinical data from literature search.
The first statement is correct if the PMS is performed in EU countries, since it is not possible to market the medical device and conduct PMS activities in European countries until the device is CE marked. But PMS can be performed for a medical device without CE mark in Non-EU countries if it is already available in market in those countries.
Post Market Surveillance is one of the important requirements in EU regulatory framework. According to article 83 of MDR, for each device, manufacturers need to plan, establish, document, implement, maintain and update a post-market surveillance system which is proportionate to the risk class of the device and it should be an integral part of the manufacturer’s quality management system. A carefully planned PMS system can detect the rare complications and risks that appear with the wide spread and long term(regular) use of the device. PMS ensures that there are no undetected safety problems and uncontrolled risks associated with the device by continuously monitoring the safety, effectiveness and quality of marketed medical devices and by taking proper corrective and preventive actions where necessary.
The statement is not correct because the PMS shall be performed after device released in the market, But the CE marking necessary for EU market, not in the NON-EU countries. PMS is the process for the manufacturers to collect and analyze the data of medical device after its launch in market (whether it is in the Non-EU countries where CE marking is not mandatory).
The relevance of PMS system in CE marking of medical device is that it will provide outputs that will generate important inputs into the technical documentation, product benefit-risk, clinical evaluation process and Clinical Evaluation Report (CER) documentation. The manufacturer will be informed about medical device sustenance in the EU market and it will allow continuous reassessment of the risk management and risk-benefit analysis.