The medical device vigilance system is the reporting and assessment mechanism set out in Articles 87 to 92 of Regulation (EU) 2017\/745, through which safety-relevant events on the market are captured, assessed, reported to authorities, and translated into actions. It covers the reporting of serious incidents and field safety corrective actions, trend reporting, analysis by competent authorities, and coordinated assessment between Member States. This entry describes the system as a whole, in particular the deadline structure, allocation of roles, and integration into post-market surveillance; the individual reporting types are described in the entries Incident and Serious Incident, Trend Report, and Field Safety Corrective Action and Field Safety Notice. <\/p>\n
Article 87 establishes the manufacturer\u2019s reporting obligation for any serious incident involving products made available on the Union market, as well as for any field safety corrective action. Excluded are expected side effects that are clearly documented and quantified in the product information and provided for in the technical documentation; these are subject to trend reporting under Article 88. Article 89 governs analysis by the competent authority and coordinated assessment, Article 90 trend analysis by the Member States, Article 91 implementing acts, and Article 92 the electronic system. The MDCG 2023-3 guidance, Revision 2 of January 2025, explains the terms in detail. <\/p>\n
The deadline depends on the severity of the event. Under Article 87(3), a serious incident must be reported without delay and no later than 15 days after becoming aware of it. In the event of a serious public health threat, paragraph 4 shortens the deadline to no later than two days; in the event of death or an unforeseen serious deterioration in a person\u2019s state of health, paragraph 5 sets a maximum of ten days. Paragraph 6 allows an incomplete initial report; paragraph 7 requires reporting even where there is doubt as to whether reporting is required. Field safety corrective actions must, as a rule, be reported before they are implemented (paragraph 8). For similar incidents involving the same product, paragraph 9 allows periodic summary reports by agreement with the coordinating authority; the Periodic Summary Report is the form intended for this purpose. <\/p>\n
The manufacturer is responsible for reporting; within the organisation, the person responsible for regulatory compliance ensures that the reporting obligations under Articles 87 to 91 are fulfilled. Authorised representatives, importers and distributors contribute by forwarding complaints and keeping records. Healthcare professionals, users and patients may report incidents to the competent authorities under Article 87(10), which then inform the manufacturer. Submission is made via the electronic system under Article 92, implemented in EUDAMED as the vigilance module, which consolidates manufacturer reports, reports on field actions, trend reports, and authority assessments. <\/p>\n
Vigilance is one part of post-market surveillance, not the whole of it. The plan under Article 84 and Annex III defines which sources are evaluated, which indicators and thresholds apply, and which methodology is used to detect trends under Article 88. Results feed into the report under Article 85 or the periodic safety update report under Article 86 and feed back into the risk management file, clinical evaluation and instructions for use. The corrective and preventive action process provides the bridge to lasting remediation: reports and trends trigger root-cause analyses, the outcome of which may range from a design change to a field action. The related term EUDAMED describes the database structure for these processes. <\/p>\n
Pharmacovigilance relates to medicinal products and is based on Directive 2001\/83\/EC and Regulation (EC) No 726\/2004. It involves reporting suspected adverse reactions in individual persons, and the marketing authorisation holder must appoint a qualified person responsible for pharmacovigilance. The reference point is the benefit\u2013risk balance of the marketing authorisation, which may be amended as a result of a signal. In medical device law, by contrast, the focus is on the event involving the device: the reportable item is the serious incident, including malfunctions and deterioration in characteristics or performance, and the deadline structure is three-tiered at two, ten and fifteen days. The outcome is typically a field action or design change, not a change to a marketing authorisation, because devices are not authorised. <\/p>\n
During a clinical investigation, the vigilance system does not apply; instead, the reporting procedure under Article 80 of the Regulation applies: serious adverse events with a causal relationship, device deficiencies that could have led to such events, and new findings relating to them are reported by the sponsor. Only once the device is placed on the market does the regime switch to Articles 87 to 92. For post-market clinical follow-up investigations, both routes may apply simultaneously, which is why the allocation must be defined in the clinical investigation plan. <\/p>\n
In practice, this means that reporting pathways, assessment criteria and deadlines for study events and market events must be described separately, yet still consolidated in a single data set. Full-service CROs such as Mediconomics support sponsors and manufacturers in setting up this reporting matrix and establishing a traceable process for transferring study data into post-market processes. <\/p>\n
Which deadline applies in the event of death?<\/strong><\/p>\n No later than ten days after becoming aware of it, if it is a death or an unforeseen serious deterioration in the state of health. In the event of a serious public health threat, the deadline is shortened to two days. <\/p>\n What applies if the reporting obligation is unclear?<\/strong><\/p>\n Article 87(7) requires reporting in cases of doubt. The report must be submitted within the applicable deadline; subsequent clarification does not change the obligation to submit the initial report on time. <\/p>\n Are complaints without an incident reportable?<\/strong><\/p>\n No, but they must be recorded and evaluated as part of post-market surveillance. Clusters may trigger trend monitoring. <\/p>\n The medical device vigilance system is the reporting and assessment mechanism set out in Articles 87 to 92 of Regulation (EU) 2017\/745, through which safety-relevant events on the market are captured, assessed, reported to authorities, and translated into actions. It covers the reporting of serious incidents and field safety corrective actions, trend reporting, analysis by […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7793","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7793","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7793\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7793"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7793"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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