The regularly updated safety report is the periodic reporting format required under Article 86 of Regulation (EU) 2017\/745, in which manufacturers compile and assess the results of their post-market surveillance for a product or a product group. In English usage, it is referred to as the Periodic Safety Update Report (PSUR). It is not a compilation folder of individual reports, but an assessment: it summarises the analysis of the data collected in accordance with the plan under Article 84 and substantiates the preventive and corrective actions derived from it. The report forms part of the technical documentation under Annexes II and III and, for custom-made devices, of the documentation under Annex XIII, Section 2. <\/p>\n
The obligation applies to manufacturers of class IIa, IIb and III devices. It does not apply to class I devices; for these, the post-market surveillance report under Article 85 is sufficient. Manufacturers of class IIa devices update the safety report as needed, but at least every two years; for classes IIb and III, an update is required at least annually. The report may be prepared per device or, where objectively justified, per device category or device group; the grouping must be justified in the report and must allow for a meaningful evaluation. It must be maintained throughout the entire lifetime of the device. <\/p>\n
In addition to summarising the results and conclusions of the data analysis and providing the rationale for and description of the measures taken, Article 86(1) specifies three explicit mandatory items: the conclusions of the benefit-risk determination, the main findings of post-market clinical follow-up, and the total volume of sales of the device together with an estimate of the size and other characteristics of the population using the device and, where practicable, the frequency of use of the device. The sales and usage data provide the reference basis without which reporting figures cannot be interpreted. <\/p>\n
Beyond the minimum requirements, manufacturers typically supplement these with an evaluation of complaints, non-serious incidents, trend reporting under Article 88, literature and registry data, and a statement on the currency of the clinical evaluation and the risk management file. The MDCG 2022-21 guidance of December 2022 describes a recommended chapter structure. <\/p>\n
The submission route depends on the type of device. For class III devices and implantable devices, manufacturers submit the report under Article 86(2) to the Notified Body via the electronic system under Article 92; the Notified Body reviews it and enters its assessment, including details of any measures taken, into the same system. For all other affected devices, the manufacturer makes the report under paragraph 3 available to the Notified Bodies as part of the conformity assessment and, upon request, to the competent authorities. Until the relevant modules of the European Database on Medical Devices are fully available, the exchange takes place via the channels provided by the Notified Bodies; the reports and assessments are subsequently transferred to the database. <\/p>\n
The related term \u201cPeriodic Summary Report\u201d concerns vigilance: it allows similar serious incidents of the same device, after coordination with the coordinating competent authority, to be submitted periodically in summary form instead of as individual reports, thereby replacing reports within the time limits of Article 87. The safety report, by contrast, is an assessment of the overall post-market data situation and does not replace any individual report. The distinction from the medicinal product periodic safety update report is also important: under Articles 107b and 107c of Directive 2001\/83\/EC, this is submitted in relation to the marketing authorisation and according to a Union-wide list of reference dates, follows a format prescribed by authorities, and may result in a Union-wide single assessment that leads to changes to the marketing authorisation. The Periodic Safety Update Report for medical devices is not approved or rejected; it is assessed by the Notified Body as part of surveillance of the issued certificate. <\/p>\n
Post-market clinical follow-up provides an explicitly named mandatory element of the report. Studies conducted as part of this follow-up\u2014such as registries, observational studies or investigations under Article 74\u2014must therefore be planned and analysed so that interim results are available in line with the reporting cycle and support statements on benefits, residual risks and frequency of use. <\/p>\n
Conversely, the report identifies evidence gaps: recurring observations without a robust data basis regularly lead to the post-market clinical follow-up plan being adjusted or an additional investigation being initiated. Full-service CROs such as Mediconomics support manufacturers in designing and analysing follow-up studies so that their results feed into the safety report on time and with robust evidence. <\/p>\n
Do class I devices require a safety report?<\/strong><\/p>\n No. Article 86 applies to classes IIa, IIb and III. Manufacturers of class I devices instead prepare the post-market surveillance report under Article 85. <\/p>\n May a report cover multiple devices?<\/strong><\/p>\n Yes, provided that a device category or device group is formed on an objectively justified basis and the evaluation does not lose its informative value as a result. The grouping and its rationale must be set out in the report. <\/p>\n What happens to the Notified Body\u2019s assessment?<\/strong><\/p>\n For class III devices and implantable devices, the Notified Body enters its assessment, including information on measures taken, into the electronic system under Article 92. It feeds into surveillance of the issued certificate. <\/p>\n The regularly updated safety report is the periodic reporting format required under Article 86 of Regulation (EU) 2017\/745, in which manufacturers compile and assess the results of their post-market surveillance for a product or a product group. In English usage, it is referred to as the Periodic Safety Update Report (PSUR). It is not a […]<\/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-7758","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\/7758","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\/7758\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7758"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7758"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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