An Integrated Approach to PMSBy Critical Software
With the entry into force of the Medical Device Regulation (EU 2017/745 MDR) on 26 May 2021, several medical device manufacturers have been updating their post-market surveillance (PMS) processes in their Quality Management System (QMS) in order to comply with the new requirements.
For companies developing software as a medical device (SaMD) and/or devices with software (SW) components, the new categorisation of the software risk class (rule 11 in MDR) has also resulted in additional PMS activities. Understanding the PMS requirements is essential for a manufacturer to be able to monitor the safety and performance of devices placed on the market and ensure compliance with the regulation.
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