People often talk about the Post Market Surveillance (PMS) requirements in the Medical Device Regulation (MDR 2017/745), as a new requirement. But PMS was required long before MDR 2017/745 entered into force. So, what has actually changed?

Post-market surveillance (PMS) is crucial in the medical device industry for several key reasons. Firstly, it is a regulatory requirement in all major markets. But the PMS requirement is not just a regulatory hurdle; it also provides many valuable and necessary insights to the manufacturer regarding their medical devices that are placed on the market.

Post market data helps identify unforeseen issues or adverse events that may arise during broader, real-world long-term use. It also uncovers new risks or changes in risk profiles that may not have been evident during clinical trials or pre-market evaluation. Feedback from real-world use can also give manufacturers a competitive advantage by enabling improvement in product design, performance, usability and reliability. Additionally, real-world evidence (RWE) gathered through PMS can streamline future regulatory submissions by providing valuable data that demonstrates product safety and effectiveness.

As previously mentioned, PMS was already required under the Medical Device Directive (MDD) and is also mandated by ISO 13485 for monitoring device performance in the field, as well as serving as input for risk management under ISO 14971. However, while PMS was required under MDD, the MDR introduced changes that significantly enhanced its scope and depth. Under the MDR, PMS requirements are more stringent and structured, requiring detailed Post-Market Surveillance Plans for all devices. The MDR also formalized the PMS obligations by requiring a Post-Market Surveillance Report (PMSR) for low-risk devices and a Periodic Safety Update Report (PSUR) for higher-risk devices. The MDR requires the manufacturer to proactively gather and assess real-world data of device performance continuouslythroughout the lifecycle of the medical device. This is likely the most significant difference. Under the MDD, monitoring of device performance was generally reactive, typically through incoming complaints. Although ISO 14971 already requires PMS data as input to risk management, MDR requires continuous review and update of the risk management file with the PMS data, ensuring that any new risks are addressed promptly and appropriately. Changes in the device’s benefit-risk profile need to be reviewed continuously, and PMS data shall be used to reassess the device’s safety, a requirement that wasn’t as strictly enforced under MDD.

In conclusion, the Medical Device Regulation (MDR) emphasizes the need for continuous vigilance and updating of the risk management file throughout a product’s lifecycle. This is not a single-time task but an ongoing process. Just as a pilot that continuously monitors the instruments during a flight, ensuring safety and responding to any signs of trouble, a medical device manufacturer must consistently track and evaluate the performance of their products, assess risks, and implement corrective actions if necessary. Regulatory compliance doesn’t end at the point of sale, it shall continue long after the device entered into the market to ensure patient safety and product reliability.

Usability has become one important part of this continuous monitoring. The evolution of usability guidelines and standards illustrates an increasing recognition of the vital role that human factors play in ensuring device safety throughout its lifetime. This is a topic that we will come back to.