Post-market surveillance and risk management – a comparison of the requirements in Europe and the USA
£40.00
Harmonise your regulatory approach – compare EU and US PMS and risk management requirements to streamline your strategy and avoid costly missteps
English
Once a medical device is placed on the market, post-market surveillance (PMS) becomes crucial for identifying any unforeseen issues or risks that may not have been detected during the development phase. This article by Silvia Tamarri, Gloria Gentile, and Caterina Grandi provides a comparative analysis of PMS and its relationship with risk management for medical devices in the European Union (EU) and the United States (USA). After outlining the regulatory framework, this article explores how the EU and the USA manage reactive and proactive PMS, adverse event reporting, required documentation, and supply chain control. The goal is to identify the key similarities and differences between the two regulatory systems, highlighting the implications for economic operators, particularly manufacturers. This comparison should help medical device manufacturers understand how and when to adopt an integrated approach to meet the requirements of both jurisdictions.
Specification: 12 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2025 issue of the Journal of Medical Device Regulation.
