ISO TR 20416 on Post-Market Surveillance published

The Technical Committee ISO/TC 210 (Quality management and corresponding general aspects for medical devices) has elaborated a new Technical Report ISO TR 20416:2020 on Post-Market Surveillance. The 43 pages report has been published this month (July 2020). It is available in English and French.

Monitoring how a medical device or combination product behaves on the market is an essential part of the product life cycle. A post-market surveillance system not only helps to ensure compliance with specific regulations, but also helps to improve the quality of products. Critical problems can be avoided through early detection. In addition, post-market surveillance helps to keep track of the market and its further development in connection with changes that could affect the use of the product.

Guidance on the post-market surveillance process including examples

The TR 20416:2020 provides guidance on the post-market surveillance process and is consistent with relevant international standards, in particular ISO 13485 (Quality Management) and ISO 14971 (Risk Management). It describes a proactive and systematic process to collect and analyze appropriate data, to provide information for the feedback processes and how to use this to meet regulatory requirements to gain experience from the post-production activities. According to ISO, the output of this process can be used for:

  • Product realization,
  • Risk management,
  • Monitoring and maintaining product requirements,
  • Communicating to regulatory authorities,
  • Improvement of processes.

In addition, the TR 20416:2020 on post-market surveillance includes 3 Annexes with examples on:

  • Data sources,
  • Data analysis methods,
  • Post-market surveillance plans for
    - surgical scalpels,
    - radiation therapy systems,
    - drug eluting stents,
    - blood glucose monitoring systems,
    - large IVD analyzer.

The new ISO/TR 20416 Medical devices - Post-market surveillance for manufacturers provides additional background information and should help to implement a post-market surveillance process according to (EU) MDR 2017 / 745.

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