The Device History Record (DHR) is the collection of manufacturing records for a specific product unit, lot, or batch. It demonstrates that this unit was actually manufactured and tested in accordance with the approved specifications, and thus represents the actual record corresponding to the target specifications of the Device Master Record. ISO 13485 requires in Section 7.5.1 the maintenance of records for each product batch that demonstrate traceability and the quantity manufactured and released for distribution, which must be verified and approved. Regulation (EU) 2017\/745 links to these records indirectly through traceability, unique device identification, and reporting obligations. <\/p>\n
A Device History Record typically contains the manufacturing date or manufacturing period, the identifying batch or serial number and the assignment of the unique device identification, the raw materials and components used with their batch numbers and incoming goods releases, the equipment employed with calibration and qualification status, the process parameters from manufacturing, cleaning, packaging, and sterilization, the results of in-process and final inspections with reference to acceptance criteria, the labels and package inserts used with version status, the personnel involved with qualification evidence, as well as documentation of deviations, rework, and concessions. It is completed by a documented release decision: Only when the record has been completely reviewed and no open deviations exist may the batch be released for distribution. ISO 13485 requires the identification of the person authorized to release. <\/p>\n
The practical value of the Device History Record becomes evident after placing on the market. According to Section 7.5.9 of ISO 13485, traceability must be possible in both directions, with expanded scope for implantable devices including component and material records as well as the recipients to whom delivery was made. In the event of complaints, incidents, or trend findings, the Device History Record is consulted for root cause analysis to determine whether a process or material relationship exists and which other units might be affected. It is therefore a fundamental prerequisite for defining the scope of field safety corrective actions and recalls, and feeds corrective and preventive actions. Retention is governed by Section 4.2.5 of the standard and by Article 10(8) of Regulation (EU) 2017\/745, with a minimum of ten years after the last placing on the market and a minimum of fifteen years for implantable devices. Since the Quality Management System Regulation became effective on February 2, 2026, the term is no longer a regulatory term in the United States; the requirements continue to apply through ISO 13485 and the remaining record requirements in 21 CFR Part 820. <\/p>\n
The Device History Record must not be equated with pharmaceutical batch documentation. In pharmaceuticals, the qualified person completes batch release as a legally assigned certification, with specific requirements for import testing, batch certificates, and retention samples; medical device law does not recognize such person-bound batch certification, but rather requires a documented release decision within the quality management system and assigns conformity assessment prior to release to the person responsible for regulatory compliance. Likewise, the Device History Record must be distinguished from the design history file and from technical documentation: it concerns a single manufacturing execution, not the design and not the conformity of the product type. Retention and reference samples are also a pharmaceutical instrument that must not be transferred wholesale to medical devices. <\/p>\n
For investigational devices, batch-specific documentation is a prerequisite for assigning each unit issued to an investigation site to a tested and released manufacturing batch. ISO 14155 requires complete traceability of investigational devices from release through shipment, storage conditions, issue to the study participant, to return or disposal. If a product defect or serious event occurs in the study, the Device History Record is the basis for causality assessment and the decision whether additional units of the same batch should be quarantined. <\/p>\n
Conversely, findings from the study, such as anomalies in packaging, labeling, or handling, must be fed back into deviation handling and corrective actions. In studies with multiple product versions, batch-specific assignment is also a prerequisite for evaluating results separately. Full-service CROs such as Mediconomics support sponsors and manufacturers in organizing the traceability of investigational devices at investigation sites, integrating release and issue documentation in an audit-proof manner, and appropriately capturing product defects from the study perspective. <\/p>\n
Must a separate record be maintained for each individual device?<\/strong><\/p>\n Not necessarily. Maintenance per batch or lot is permissible, provided traceability to the individual unit is ensured. For implantable devices, ISO 13485 Section 7.5.9.2 requires extended traceability. <\/p>\n Who releases the batch?<\/strong><\/p>\n A designated, authorized person within the quality management system according to a documented procedure. A legally defined role such as the qualified person in pharmaceutical law does not exist in medical device law. <\/p>\n May Device History Records be maintained electronically?<\/strong><\/p>\n Yes, provided the applications used are validated, access rights and change tracking are secured, and the records remain readable and available unchanged throughout the entire retention period.<\/p>\n The Device History Record (DHR) is the collection of manufacturing records for a specific product unit, lot, or batch. It demonstrates that this unit was actually manufactured and tested in accordance with the approved specifications, and thus represents the actual record corresponding to the target specifications of the Device Master Record. ISO 13485 requires in […]<\/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-7870","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\/7870","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\/7870\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7870"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7870"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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