DANSK DSF/FPRCEN ISO/TR 20416 PDF

The proposed Technical Report is to 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.