Dutch Regulators Find Ongoing Compliance Issues for Post-market Surveillance

By Beth Pugh, Annette Van Raamsdonk and Evangeline Loh

A recent report by Dutch medical device market regulators has found that post-market surveillance (PMS) requirements under the European Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Medical Devices Regulation (2017/746, IVDR) continue to challenge manufacturers. 

Background on post-market surveillance globally

PMS has been a pivotal topic. The MDR and IVDR officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifecycle of the device.

In 2020, ISO released ISO/Technical Report (TR) 20416:2020 on PMS which was published as a guide to assist manufacturers.

Background on post-market surveillance in the EU

The MDR and IVDR also promulgated an extensive PMS system for manufacturers, which includes the corresponding PMS Plan and then documented results as either the PMS Report or Periodic Safety Update Report (PSUR), depending on the risk class of the device.

PMS became compulsory for devices in the EU compliant with the regulations in advance of the Date of Application (DoA) and then after for all legacy devices and MDR and IVDR-compliant devices. Notified bodies have been reviewing and will be reviewing PMS compliance.

European guidance on post-market surveillance

An EU guidance on PMS is expected in the near future.

There is guidance on PSUR for medical devices (MDCG 2022-21). And MDCG 2022-8 mentioned that for legacy self-certified IVDs upclassified to Class C or Class D, PSURs are voluntary.  

Manufacturers of Class IIa, IIb, and III medical devices, need to review and understand the guidance on PSUR.

The Competent Authorities and post-market surveillance

The EU Competent Authorities have also focused on PMS. Swissmedic is one of the regulators that has requested manufacturers' PMS documents even when a Notified Body is involved.   

The Dutch authority, Healthcare and Youth Care Inspectorate (IGJ) has been very overt about their PMS activities. In September 2023, IGJ described its PMS assessment framework.

IGJ post-market surveillance report

IGJ posted (8 October) a report on their inspection of 13 manufacturers based in the Netherlands. The outcome was that each of the visited manufacturers was not compliant with the PMS requirements.  

The IGJ report highlighted areas of concern: the PMS plan is not well-developed and lacks suitable indicators or threshold values; manufacturers have limited knowledge of PMS and equate it with vigilance; PMS is not specific to the medical device; and manufacturers don’t understand when action is required based on PMS.

IGJ continues to advance the import of a well-functioning PMS to detect potential issues with medical devices at an early stage.

Concluding remarks

Post-market surveillance is a critical element to support the continued safety and effectiveness of a medical device. It is expected that manufacturers devote the necessary resources for this activity. PMS needs to be specific for the medical device or IVD. The plan needs to be developed in advance, identifying all relevant data sources and including the appropriate indicators, threshold values, and the consequences/activities for the manufacturer and the device when the data is at the indicator or threshold value. Manufacturers must assess their PMS processes and documentation in order to resolve any deficiencies.