PMS requirements for medical devices and IVDs in the EU
The EU Directives as well as the EU Regulations, the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR), require manufacturers and other economic operators to plan, implement, and maintain a Post-Market Surveillance system. The MDR/IVDR defines PMS as:
“[All] activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market.”
PMS is intended to ensure the safety and performance of devices throughout their life cycle by collecting data about your device on the market, analyzing that data, and determining if corrective actions are needed.
Despite the post-market implications, PMS begins before your device enters the market. A PMS plan must be submitted for Notified Body or Competent Authority review as part of the conformity assessment process for CE Marking. PMS requirements apply for all devices, irrespective of their classification, including legacy devices regulated under EU Directives. The PMS Plan should explain how you will systematically and proactively collect and analyze PMS data, what kind of data, reporting and documentation procedures, and how you will implement and assess the effectiveness of Field Safety Corrective Actions (FSCAs). Your PMS system should scale appropriately according to the device classification and type of device.
PMS documentation requirements under the EU MDR and IVDR
Medical device manufacturers must have an established PMS procedure, PMS Plan, and a PMS Report or Period Safety Update Report (PSUR), depending on your device classification. PMS is an integral part of every manufacturer’s QMS. You are required to continually, and systematically plan, document, assess, update and report collected PMS data. This includes the involvement of feedback from your economic operators, specifically distributors and importers. Class I (Class A) devices must maintain a PMS Report with regular updates as needed. Class IIa, IIb, and III (Class A sterile, Class B, C, D IVD) devices must maintain a Periodic Safety Update Report (PSUR) with regular updates as needed. The PSUR is a more comprehensive PMS Report that also includes a benefit-risk determination, conclusion from Post-Market Clinical Follow-up (PMCF) activities and studies, product sales volume, and more. The frequency of required PSUR updates may be determined by the manufacturer, but manufacturers of the highest risk devices and IVDs must update their PSUR at least annually.
PMS trend reporting requirements under the EU MDR and IVDR
MDR Article 88 and IVDR Article 83 include a legal requirement for medical device manufacturers to conduct a trend analysis for PMS. The results must be reported if statistically significant trends in device safety and performance data reveal potential risks. These PMS data sources might come from corporate and non-corporate sources, which can make data collection more complex.
Trend reporting means that medical device manufacturers must define their data analysis process (methodology for data source analysis) for identifying trends, document the trend analysis, and define how identified trends will be further assessed for risk activities. This process may include several decision-making stages and relates to the frequency or severity of PMS data. Identifying a meaningful change requires establishing threshold values for current data and defining action levels that require action.
In other words, to meet these PMS trend reporting obligations, medical device manufacturers must link their PMS process in their QMS with their vigilance and CAPA processes, or even the data analysis process. Inside the PMS process, it is recommended to establish reasonable criteria for significant changes on the device. The significance may be different based on the intended purpose and use claims of associated risk of the device.
