Adding to the discussion, also in EU the manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful.The plan must outline how to collect information from sources such as:
information from vigilance, records referring to non-serious incidents and data on any undesirable side effects, information from specialist or technical literature, databases and/or registers
information from feedback and complaints, provided by users, distributors and importers
publicly available information on similar medical devices.
A company can use existing processes, or implement new ones, to achieve the above. These could be:
complaints procedures
vigilance procedures
checking of competent authority websites for information on adverse events or recalls of similar devices
post-market clinical follow-up (PMCF) studies
setting up key-word alerts on search engines
social media
feedback from users (via email/website/surveys)
In US: Passive surveillance systems at the FDA are centered on the DMR, through which manufacturers, physicians, and consumers submit reports of device-associated malfunctions, injuries, or deaths.