MDCG outlines postmarket surveillance expectations under MDR/IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has outlined the postmarket surveillance (PMS) requirements that medical device and in vitro diagnostic makers should adhere to as part of their quality management system (QMS). The requirements are based on provisions in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

On 19 December, MDCG published the guidance detailing expectations for medtech manufacturers regarding the setup of their PMS system, PMS plan, and the activities they need to conduct within the PMS plan, as well as how the PMS system fits into other aspects of their QMS. It also notes that the development of periodic safety update reports (PSUR) is outside the scope of the document, as are requirements for specific in-house devices used by healthcare providers.

Broadly, the guidance reminds manufacturers that they are required to gather PMS data on their devices, use that information to update technical documents, identify the need for corrective and preventive actions, provide more transparency, and work with national competent authorities in the postmarket setting.

“After having established the initial PMS plan, which is part of the technical documentation, the first PMS process cycle begins when the first device has been placed on the market/put into service and concludes with a report,” said MDCG. “However, surveillance activities and data collection must be systematically performed and recorded on a continuous, ongoing basis, throughout the entire period between the first placing on the market/putting into service and the end of the intended lifetime of the last device placed on the market/put into service.”

While manufacturers are required to implement PMS systems that are suited to effectively gather postmarket information and analyze it to help ensure the product continues to maintain its quality, performance, and safety throughout its lifecycle, the MDCG also emphasized that it's in the manufacturer's interest to use the system to improve the product.

"For a successful implementation of the PMS system the manufacturer must provide for appropriate structures, procedures, processes and resources," the group added. "The effectiveness of the PMS system should be reported to top management, e.g., via management review."

The guidance also notes that manufacturers of custom-made devices (CMD) are expected to gather data from postmarket clinical follow-up (PMCF) as part of their PMS requirements.

MDCG stated that manufacturers should start developing their PMS plan as part of the product development plan and consider the information they need to collect proactively once the device reaches the market. It also noted that a PMS plan can cover a single device or a group of devices.

“The PMS plan specifies the aspects of the device or group of devices to be monitored, the frequency of monitoring, and the methods to be applied,” said MDCG. “The chosen methods should be appropriate and based on the device’s risk profile, and the rationale for selecting these methods needs to be documented.”

When collecting PMS data, MDCG stated that manufacturers must determine which sources of information are relevant and appropriate based on the device, noting that sources such as healthcare providers and patients should be considered as potential data sources.

“It is up to the manufacturer to select the most appropriate methods, parameters, values, processes, and tools depending on the type of the device,” said the guidance. “Data quality and integrity should be considered before analysing data to ensure the information is reliable.”

MDCG notes that PMS data collection begins after a manufacturer declares that their device meets conformity requirements and has been placed on the market. The group added that in some cases, the manufacturer may be required to generate data from real-world use, especially for higher-risk devices or those with novel features.

After collecting the PMS data, the guidance states that it should be analyzed and characterized to allow comparison with similar devices, ensuring it continues to meet acceptable levels of the benefit-to-risk ratio. However, if the data finds previously unknown side effects or other deficiencies, they should take proper risk actions based on their risk management procedures.

MDCG guidance

MDCG outlines postmarket surveillance expectations under MDR/IVDR

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