July 8th, 2020, The International Organization for Standardization (ISO) published the Technical Report 20416:2020 Medical devices – Post-market surveillance for manufacturers.
ISO/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 analyse 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. The output of this process can be used:
- As input into product realization.
- As input into risk management.
- For monitoring and maintaining product requirements.
- For communicating to regulatory authorities.
- As input into improvement processes.
In addition, the TR 20416:2020 on post-market surveillance includes three Annexes:
- A. Examples of data sources
- B. Examples of data analysis methods
- C. Examples of post-market surveillance plans
The aim of this technical report is to provide guidance to manufacturers who are planning and executing their post-market surveillance activities. Other organizations, such as importers, distributors and reprocessors, that are connected to the manufacturer in the product lifecycle and who play a role in post-market surveillance activities, can also utilize the guidance for their activities.
What does this mean to you?
ISO/TR 20416:2020 does not specify a manufacturer’s actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. It is not intended to replace or change applicable regulatory requirements for post-market surveillance. Nevertheless, this document can be of added value to your company by providing additional insight and inspiration for setting up your own MDR/IVDR compliant Post Market Surveillance system.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.