The post-market surveillance report is the mandatory evaluation document for market monitoring required for Class I products. Article 85 of Regulation (EU) 2017\/745 requires manufacturers of such products to prepare a report containing a summary of the results and conclusions of the analyses of the data collected as a result of the post-market surveillance plan, together with a rationale and description of any preventive and corrective actions taken. It must be updated as necessary and made available to the competent authority upon request. For Class I, this represents a distinct, significantly leaner reporting obligation. <\/p>\n
The report is not a standalone instrument, but rather the result of a system. Article 83 requires a planned, proactive post-market surveillance system as part of the quality management system, while Article 84 requires the associated plan, the requirements of which are set out in Annex III, Section 1. Only the data collected and evaluated according to this plan form the basis of the report under Article 85. If a plan with defined indicators, thresholds, and methods is missing, the report is not robust. The results must flow back into the risk management file, clinical evaluation, and, if applicable, design and labeling. <\/p>\n
The wording of Article 85 specifies two mandatory components: the summarized results and conclusions of the data analyses, as well as the rationale and description of any preventive and corrective actions taken. In practice, a structure is recommended that separates product scope, reporting period, data sources, quantitative evaluation relative to sales volume, assessment against the plan’s thresholds, trend analysis, conclusions on the benefit-risk ratio, and derived measures. A key statement is whether the data confirm the assumptions of the risk analysis and the clinical evaluation. A report that only lists complaint numbers does not meet the requirement. <\/p>\n
Potential sources include complaints, feedback from users, distributors, and importers, service reports, internal manufacturing and testing data, public databases and recall notices, literature, and findings on comparable products. In addition, post-market clinical follow-up (PMCF) according to Annex XIV Part B is required, unless it has been justified as excluded. The evaluation should relate frequencies to the quantity placed on the market so that changes over time remain interpretable. For Class I products with low reporting volumes, the justification for why no signals are recognizable is precisely the decisive part of the argument. <\/p>\n
Unlike the periodic safety update report (PSUR) for higher classes, the report under Article 85 has no fixed frequency; it is updated as necessary. In practice, a regular cycle is established and documented in the plan, supplemented by triggers that prompt an immediate update, such as new risks, increases in frequency, changes to the product, or field safety corrective actions. The report is part of the technical documentation according to Annex III and must be kept available for at least ten years after the last device has been placed on the market, in accordance with Article 10(8). No submission takes place: it is neither uploaded to a database nor routinely transmitted, but is presented to the competent authority upon request. <\/p>\n
For Classes IIa, IIb, and III, the regularly updated periodic safety update report (PSUR) under Article 86 applies instead of Article 85. This additionally requires conclusions of the benefit-risk determination, the main findings of the PMCF, and information on the total sales volume, the number and characteristics of users, and, where practicable, the frequency of use. It is subject to fixed deadlines: at least annually for Class IIb and III, and as necessary and at least every two years for Class IIa. None of these requirements apply to Class I; a summary of safety and clinical performance (SSCP) is also not required. Sterile products, products with a measuring function, and reusable surgical instruments remain Class I products despite the involvement of a Notified Body and fall under Article 85. The basic structure of the regulation is described in the entry EU MDR 2017\/745. <\/p>\n
Even for Class I products, the report is the interface between market monitoring and clinical evidence. If the evaluation shows signals that the clinical evaluation does not cover, this may result in the need for a follow-up study; conversely, the report provides the justification if such a study is deemed unnecessary. This justification must be based on documented data, not solely on a lack of feedback. If a follow-up study is conducted, its results must be incorporated into the next report. <\/p>\n
In practical terms, this means aligning the endpoints of follow-up studies with the indicators defined in the plan and establishing the data flows between the study, complaint management, and risk management early on. Otherwise, evaluations are created that cannot be merged. Full-service CROs like Mediconomics support manufacturers in creating and updating post-market surveillance reports, in deriving and conducting follow-up studies, in integration with risk management and clinical evaluation, and in medical writing. <\/p>\n
How often must the report be prepared?<\/strong><\/p>\n Article 85 does not specify a frequency; the report is updated as necessary. A cycle established in the plan with defined triggers for an early update, such as new risks or corrective actions, is advisable. <\/p>\n Must the report be submitted to an authority?<\/strong><\/p>\n No. It is part of the technical documentation according to Annex III and is only made available to the competent authority upon request. An upload to a European database is not intended. <\/p>\n Does a periodic safety update report apply to Class I products with a Notified Body?<\/strong><\/p>\n No. Sterile products, products with a measuring function, and reusable surgical instruments remain Class I. Article 85 applies to them, not Article 86. <\/p>\n The post-market surveillance report is the mandatory evaluation document for market monitoring required for Class I products. Article 85 of Regulation (EU) 2017\/745 requires manufacturers of such products to prepare a report containing a summary of the results and conclusions of the analyses of the data collected as a result of the post-market surveillance plan, […]<\/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-7753","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\/7753","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\/7753\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7753"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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