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Tying PMS and PMCF Requirements Back to Risk Management

Author: Tara Miller | Date: November 28, 2023

Tara Miller, MSc, CROM

Medical device manufacturers’ obligation to meet regulatory requirements continues throughout the medical device lifecycle, including the post-production phase (post-market). Medical device manufacturers must implement an effective post-market surveillance system per the various applicable regulations. 

What is post-market surveillance?

Post-market surveillance (PMS) is a systematic process to monitor the safety, performance, and quality of devices on the market. In the United States, PMS is required for certain Class II or Class III devices. In the European Union (EU), all devices require PMS. Annex III of Medical Device Regulation (MDR) 2017/745 details the requirements for PMS. There are multiple approaches medical device manufacturers can take to obtain the data to be used as part of their post-market surveillance.

Post-market requirements include post-market surveillance, vigilance reporting, and handling customer complaints and recalls. The purpose is also to provide early warning of product quality issues and for input into the corrective and preventive action process. 

Developing a robust post-market surveillance plan is essential for medical device manufacturers to comply with the rigorous requirements of monitoring device safety and quality, especially as mandated in the United States for certain Class II or Class III devices and universally in the European Union under MDR 2017/745 Annex III.

What is post-market clinical follow-up?

Post-Market Clinical Follow-up (PMCF) is the continuous process of proactive clinical data collection of a CE-marked device. From the moment your medical device is placed on the market and used in clinical practice, real-world data are generated. There are multiple options for selecting the appropriate PMCF methodology, including clinical studies, registries, retrospective data collection, and user surveys.

What is post-market data?

  • Complaints
  • Surveys
  • 522 post-market surveillance 
  • Controlling nonconforming products or materials
  • Service reports
  • CAPAs

 Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act – Guidance for Industry and Food and Drug Administration Staff (fda.gov)

Real-world data (RWD) can be obtained through post-market activities and should be integrated with the risk management system. Data can be monitored, and necessary changes can be implemented in real time. 

Post-market surveillance for medical devices  is  a regulatory requirement in substantial markets, including the United States (US) and European Union (EU)/ However, it is also a good practice and a means for leadership to view device performance post-production. 

Utilizing PMS as a proactive activity with consideration for advancements in technology and increased regulatory requirements is vital to reassess the device benefit/risk ratio throughout the device’s lifetime.

PMCF under EU MDR

Post-market clinical follow-up (PMCF) is only one component of PMS and should begin after the product receives the CE Mark. Some of the data and evidence obtained through PMCF activities include:

  • Identify previously known side effects
  • Identify and analyze emergent risks
  • Ensure continued acceptability of the benefit-risk ratio
  • Identify systematic misuse or off-label use and verification that the intended use is correct
  • Part of the clinical evaluation for the device

The PMCF Plan will outline the process, and the findings will be documented in an evaluation report. The report is part of the device’s technical documentation and the Clinical Evaluation Report (CER). 

The EU MDR requires every medical device manufacturer to review the criteria in the European Commission regulation that governs PMCF and determine if their product requires a PMCF study. Not every device will require a study. However, manufacturers must include a rationale in the technical documentation for not conducting a study. The device’s level of risk and novelty are the two primary criteria that determine the need for a study.

Conducting post-market surveillance under EU MDR as a proactive and systematic approach to tie PMS and PMCF data to risk management allows for real-time monitoring and early intervention. Please note that PMCF data intended to demonstrate continuing safety and performance should be sourced from the evaluated device.

For example, data from equivalent or similar devices may be used to update the information relating to the state of the art, identify and further assess relevant safety outcomes, etc.

Additionally, the estimation of risk and risk management using data from existing technologies and state-of-the-art therapeutic standards, including risks and benefits of current treatments, informs risk estimation and approaches to minimize risk. 

The benefit/risk profile of the device has been determined to be acceptable in the context of the state of the art, which describes the gold standard (highest level of protection of health and safety) and defines what are considered acceptable risks and side effects, what is considered beneficial, and which duration of effects, is considered acceptable.

Thus, the state-of-the-art yields information has been established to determine the safety and performance of a device that is compatible with current standards (in comparison to available treatment options). The CER has established the state of the art and is used throughout the clinical evaluation.

Expert Guidance for Regulatory Clarity

If you struggle to make sense of PMS and/or PMCF, contact Regulatory and Clinical Affairs and Sterling Medical Devices, now Vantage Medtech. We can help! 

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