MDR and IVDR: Meeting New Post-Market Surveillance Requirements
In today’s ever-changing regulatory landscape, bringing new medical devices to market is only half the battle. Once devices are launched, there’s more work to be done, including the start of post-market surveillance (PMS).
Regulatory authorities in most markets, including the United States and European Union (EU), require manufacturers to conduct post-market surveillance on medical devices once they are commercialized. Post-market surveillance is a vital process in the product lifecycle, as it requires medical or in vitro diagnostic device manufacturers to continuously monitor the device’s performance and gather real-world evidence to support product safety and effectiveness. It also enables these manufacturers to quickly implement the necessary corrective actions and mitigate adverse events.
Historically, the PMS requirements for medical devices have been reactive, focusing primarily on the reporting of serious incidents such as device malfunctions and patient injuries. However, today there’s a shift toward more proactive planning and monitoring with the release of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
In this article, we highlight the essentials for post-market surveillance under the new European medical device regulations and discuss how a cloud-based quality management system (QMS) can help you simplify the process and achieve EU MDR and IVDR compliance.
EU MDR and IVDR Requirements of Post-Market Surveillance
If you currently market and sell medical or in vitro diagnostic devices in the EU, your post-market surveillance program will need to include these key elements under the new regulations.
Post-Market Surveillance Plan:
Manufacturers must develop a comprehensive plan which outlines the processes, methods, protocols, and tools used to:
- Collect data related to serious incidents, product trends, customer complaints, user feedback, etc.
- Assess collected data
- Assess risk-benefit and effective risk management
- Investigate complaints and other market-related information gathered in the field
- Manage events subject to reportable trends
- Implement corrective actions
- Trace potentially defective products
- Communicate with competent authorities, notified bodies, economic operators, and users
Once completed, the post-market surveillance plan should be included in the technical file that is used for your conformity assessment and CE certification.
Post-Market Clinical/Performance Follow-up (PMCF/PMPF):
To confirm the safety and performance of a device throughout its lifecycle and ensure the continued acceptability of identified risks, manufacturers will need to conduct a post-market clinical follow-up (PMCF) for medical devices or post-market performance follow-up (PMPF) for in vitro diagnostic devices.
The post-market follow-up is intended to gather real-world clinical data on the device and involves activities such as:
- Gathering feedback from patients and medical professionals via surveys
- Screening scientific literature
- Analyzing data from existing device registries
- Conducting formal clinical investigations
The PMCF and PMPF should be conducted according to a formalized plan, which specifies the methods for proactively collecting and evaluating clinical data. The findings of your post-market follow-up should be analyzed and documented in a report and included in your technical file.
Post-Market Surveillance and Periodic Safety Update Reports:
PMS reporting requirements will depend on the classification of your device.
Class I medical devices and Class A and B in vitro diagnostic devices require a post-market surveillance report (PMSR). The PMSR should provide a summary of results and conclusions about the collected surveillance data. It should also provide the rationale and description of any corrective and preventive actions (CAPAs) taken. This report should be provided or updated once every three years (at minimum) for Class I medical devices or on an as-needed basis for Class A and B in vitro diagnostic devices.
A periodic safety update report (PSUR) is required for devices in higher risk categories. This includes Class IIa, IIb, and III medical devices as well as Class C and D in vitro diagnostic devices. In addition to the information compiled in the post-market surveillance report, the PSUR should also include key findings from your post-market clinical follow-up, conclusion of the risk-benefit determination, and data on sales volumes, user population, and frequency of use. This report should be updated every two years (at minimum) for Class IIa devices and at least once a year for Class IIb, III, C, and D devices.
Streamlining Your Post-Market Surveillance With Cloud QMS
Managing all the documentation and clinical data associated with post-market surveillance may seem daunting, especially if you are using manual, outdated systems. By adopting a cloud-based quality management system like Arena QMS, your post-market surveillance documents and other essential data are electronically linked to the entire product record. This enables greater visibility, traceability, and control throughout the entire lifecycle and reduces compliance risks. Arena quality templates can be leveraged to help you prepare your PMS plans and reports, eliminating any guesswork on your end. When it’s time for a conformity assessment or in the event of an unannounced audit, your PMS information can be easily extracted and included with your technical file, so you’ll stay on track with achieving EU compliance.