With the new European Medical Device Regulation soon to be fully in place for Medical Device manufacturers, post-market surveillance (PMS) activities are becoming more and more of key importance.
The MDR introduces several new requirements related to medical devices post-market surveillance (PMS), such as the Periodic Safety Update Report and the Post-market clinical follow-up, both aimed at ensuring the safety of the device after it has been placed on the market. to respond to these new requirements, a new ISO standard / technical report has been developed, named ISO/TR 20416, defining the requirements for the post-market surveillance plan, the data collection methodology and other related process.
It is more and more fundamental to fully comprehend the links between post-market surveillance and other quality system processes such as risk management , labelling and clinical evaluation, as the European medical device regulation requires to clearly demonstrate this interconnection.
Here we present an e-book of 36 pages that provides a practical guideline to post-market surveillance activities according to EU MDR 2017/745. This document represents a comprehensive overview of the medical devices PMS requirements for the European market. After all the changes introduced through the MDR, there has been the necessity of one unique document that explains and discusses the medical device post-market surveillance requirements.
Specifically, the topics covered by the e-book are:
- ISO 20416:2020 and the New Requirements for Post-Market Surveillance Activities for Medical Devices
- Deep Dive in the Post-Market Surveillance (PMS) Processes according to EU MDR 2017/74
- The Post-Market Clinical Follow-up
- Requirements Periodic Safety Update Report according to EU MDR
- Template for Periodic Safety Updated Report according to European Medical Device Regulation
- Vigilance Reporting Requirements according to EU MDR 2017/745
This Guideline on Post-Market Surveillance (PMS) Activities provides an overview of new processes such as PMCF (Post-Market Clinical Follow-up) and PSUR (Periodic Safety Update Report) and it includes as well an example of PSUR template. Moreover, an overview of the vigilance reporting system according to EU MDR 2017/745 is discussed.
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