The role of post-market surveillance (PMS)
With the MDR in effect, manufacturers are required to maintain a PMS system for their medical devices. PMS is a systematic procedure to collect and review information on medical devices that are already on the market. Before a medical device can be launched, it must undergo rigorous testing to protect consumers from risk. The drawback of pre-market data is that it only reflects short-term periods of use. But when certain devices are in clinical use, many incidents are reported.
Constant monitoring of the device enables early identification of hazards and manufacturing problems. It facilitates early identification of associated risks and provides the manufacturer with early feedback of device use in a real-time environment, thereby maintaining high product quality. This is an advantage for both the manufacturer and the patient.
Requirement set out in the EU Medical Devices Regulation
As the requirements applicable to medical devices have changed and expanded significantly, the scope and objective of PMS within the European Union is carefully set out in (Definition 60) Article 2 of the EU Medical Devices Regulation (MDR 2017/745):
“…all activities carried out by the manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”2
The MDR requires medical device manufacturers to be proactive in their efforts and set out a plan for PMS. A PMCF (post market clinical follow up) study or plan is expected. A reactive PMS system collects post-market data from complaint and incident reports and failure analysis, while a proactive system can gain insights on a device in near-real time through electronic medical records, claims databases, literature, and even customer surveys on social media.
The output of these PMS systems should be documented in a periodic safety update report (PSUR), which is maintained for higher-class devices. The post-market data needs to be verified against quality management system (QMS) processes.
Risk severity and frequency is updated in risk management. A clinical evaluation report is updated with the gathered information. The feedback can be incorporated for design improvements.
Addressing challenges for medical device manufacturers
Medical device manufacturers must identify potential sources of input for the PMS system (incidents, data bases, literature, sales contacts, etc.). The foremost task is to create a cross-functional PMS team. Collaborative, cross-functional efforts can be established to understand accuracy and analysis techniques. In addition to subject-matter experts, it should include regulatory, QA, and marketing experts and field service technicians. If the manufacturer has experience with this device, it is easier for them to identify the target population and foresee the risks. Similarly, if a new technology is being introduced in the market, an effective monitoring program has to be established to ensure early detection of problems. Digital tools can now analyze complaints and market experiences. Tracing devices and identifying corrective actions requires properly established systems and tools.
A one-size-fits-all approach is not appropriate for PMS. It is important to note that the requirements for PMS should be established according to the risk associated with the device based on its intended use. Post-market surveillance is one of the several focus areas of the new EU MDR. Quality and regulatory compliance professionals must educate themselves on these new requirements.
Reach out to us for a robust PMS program that detects early problems and ensure corrective actions in compliance with relevant legislation, and continues to monitor the long-term performance of the device, adding value beyond compliance.
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Dr. Richa Dayal is a domain expert in Medical Devices and Healthcare. She is a qualified medical doctor (MBBS) with engineering expertise (M. Tech in BioMedical Engineering -IIT Bombay). She leverages her expertise withing the Medical Solutions Group at Capgemini. She is well versed with the regulations influencing the medical device product lifecycle.