A new draft technical information report (TIR) developed to establish a common understanding of postmarket tools and activities for medical devices, AAMI/ISO DTIR20416:2020 Medical devices—Post-market surveillance for manufacturers, has been approved by the AAMI Standards Board and registered by the American National Standards Institute (ANSI). The draft TIR is available as a preorder for the final TIR, which is expected later this year.
“The main reason AAMI decided to provide the draft available before the International Organization for Standardization (ISO) publication was to give the medical device manufacturers additional time to understand the requirements of their systems that needs to be in place by the time the European Medical Device Regulation compliance takes effect on May 26, 2020,” says Wil Vargas, director of standards at AAMI and the committee manager for ISO/TC210, the parent ISO technical committee that developed ISO TR 20416.
DTIR20416:2020 is intended to be used by medical device manufacturers to guide the planning and execution of postmarket surveillance activities as described in AAMI/ISO 13485:2016 Medical devices–Quality management systems–Requirements for regulatory purposes and ANSI/AAMI/ISO 14971:2019 Medical devices—Application of risk management to medical devices, as well as to facilitate international cooperation in this area.
Specifically, DTIR20146:2020 outlines a postmarket surveillance process for generating information a manufacturer can use for:
- Product realization
- Risk management
- Monitoring and maintaining product requirements
- Improvement processes
- Communicating to regulatory authorities
While postmarket surveillance data collected through methods described in DTIR20416:2020 can help manufacturers communicate with regulatory authorities, the DTIR’s scope doesn’t include market surveillance by national authorities or actions legally required to be performed by manufacturers as part of postmarket surveillance or vigilance.
The final version of AAMI/ISO DTIR20416:2020, which is expected to publish in early 2020, may contain slight editorial changes from the draft. Those who order the draft in the AAMI Store, using product code “20416PREORDER,” will be the first to receive the final TIR. When the final version is published, AAMI will send those who purchased the draft a link to download the report.