there are differences. In contrast to reporting of medical products reports of side-effects play only a minor role with most medical devices. The vast majority of the medical device reports are related to medical device defects or failures. Other notable differences are in the obligations to report by other actors that aren't manufacturers, in the US user-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown. This is in contrast to the voluntary reporting of AEs with medicinal products. Similar obligations exist in multiple European countries. The European regulation on medical devices and the European regulation on in vitro diagnostic medical devices (IVDR) obliges other economic operators most notably importers and distributors to inform manufacturers, and in certain instances the authorities, of incidents and safety issues with medical devices that they have distributed or imported in the European market. For herbal medicines The safety of herbal medicines has become a major concern to both national health authorities and the general public. The use of herbs as traditional medicines continues to expand rapidly across the world; many people now take herbal medicines or herbal products for their health care in different national health-care settings. However, mass media reports of adverse events with herbal medicines can be incomplete and therefore misleading. Moreover, it can be difficult to identify the causes of herbal medicine-associated adverse events since the amount of data on each event is generally less than for pharmaceuticals formally regulated as drugs (since the requirements for adverse event reporting are either non-existent or are less stringent for herbal supplements and medications). Novel sources With the emergence of advanced artificial intelligence methods and social media big data, researchers are now using publicly posted social media data to discover unknown side effects of prescription medications. Natural language processing and machine learning methods are developed and used for identifying non-standard expressions of side effects. Industry associations Boston Society of Pharmacovigilance Physicians. See also Adverse drug reaction Adverse effect (medicine) Boston Collaborative Drug Surveillance Program Consultant pharmacist COSTART – Coding Symbols for a Thesaurus of Adverse Reaction Terms DrugLogic European Medicines Agency EudraVigilance Food and Drug Administration (US FDA) International Society for Pharmacoepidemiology International Society of Pharmacovigilance List of withdrawn drugs Society of Pharmacovigilance, India (SoPI) MedDRA