Post-market Surveillance
What is PMS?
Post-market surveillance refers to the requirement that manufacturers monitor their medical devices after being approved for sale and seeing in-market use. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).
Technological advances and increased regulatory requirements—particularly the more stringent ones included in the new European Medical Device Regulation (EU MDR)—are pushing a more proactive process. The enhanced regulatory requirements are also requiring for the post-market surveillance process to have a feedback loop with Design Quality, Clinical Evaluation, and Technical Documentation to utilize real-time performance data of the device to anticipate and curtail events before they occur.
How do you conduct post-market surveillance?
At a high level, manufacturers must take these steps to conduct PMS:
- Develop a PMS plan, which includes an assessment of whether Post-Market Clinical Follow-up (PMCF) is required
- Implement the plan
- Generate PMS reports based on the findings
A PMS plan details a manufacturer’s strategy for continuously monitoring and collecting data and safety information on its device. The PMS plan is part of the device’s technical documentation and outlines the criteria for the risk/benefit assessment of the device and processes for:
- Collecting and analysing data
- Following up on collected complaints
- Communicating information to regulators and users
- Taking corrective actions on devices
- Producing a PMCF plan or a rationale for why PMCF is not required
Reporting requirements vary by region, as seen below. Most reports typically include data analysis and a description of the corrective and preventative actions taken. These reports are part of a device’s technical documentation, and manufacturers must update them regularly according to the relevant regulatory bodies’ timelines.
- In the US, the FDA requires that manufacturers submit a Periodic Adverse Drug Experience Report (PADER/PAER).
- In the EU, manufacturers of low-risk Class I devices must create a post-market surveillance report (PMSR). Manufacturers of Class IIa, Class IIb, and Class III devices must submit a periodic safety update report (PSUR).
EU MDR introduces new and expanded requirements that increase compliance efforts. Annex III of the MDR 2017/745 details the EU requirements for PMS. The EU market also has a deadline looming, as the new EU MDR takes effect on May 26, 2021. Manufacturers should ensure that their PMS processes are fully compliant by this date.
With deep expertise in post-market surveillance requirements, Rico solutions is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.
How We Help You
Performing a comprehensive IVDR gap analysis and QMS development and Implementation
Usability Engineering (UE) Practice
