Medical devices—Post-market surveillance for manufacturers
PLEASE NOTE: This document, known as a Draft Technical Information Report (DTIR), is not considered a final TIR and there may be slight editorial changes to the final publication. By ordering this draft, you'll be among the first to receive the final TIR, which is expected to be published in early 2020. When the final version is published, AAMI will send a link to download it to those who have purchased AAMI/ISO DTIR20416.
This Technical Report will provide a common understanding of post-market surveillance, or PMS facilitating international cooperation in this area. The Technical Report is intended for use by manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices. The proposed Technical Report aims to describe a comprehensive data collection process and activities that allow characterization of the behavior of the devices as used in practice, and identify necessary and/or possible actions. PMS information may include material that requires reporting to Regulatory Authorities. The proposed Technical Report will not provide information for such reporting, nor for achieving compliance with any other (PMS) requirement by Regulatory Authorities. Market surveillance by national authorities, as well as actions legally required to be performed by manufacturers as part of PMS or vigilance are outside the scope of the proposed Technical Report. The document is not intended to replace or change national or regional legislation on PMS.
A preview of this document is available here.
PDFs are available for download up to 60 days after purchase.