A reprocessable medical device is a product that the manufacturer intends for reuse after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. Regulation (EU) 2017\/745 uses the term \u201creusable device\u201d and, in Annex I Chapter II Section 11.2, sets the requirement to design devices, where necessary, so that cleaning, disinfection and repeated sterilisation can be carried out easily. Annex I Chapter III Section 23.4 point (n) additionally requires the instructions for use to specify appropriate reprocessing procedures, including validated procedures for re-sterilisation, and to clearly indicate how the end of reusability can be recognised. This manufacturer-intended reuse must be strictly distinguished in legal terms from the reprocessing of single-use devices under Article 17. <\/p>\n
The reprocessing cycle is part of the device design. Material selection, surfaces, gaps, lumens, detachable assemblies and resistance to cleaning chemicals and thermal stress determine whether reproducible reprocessing is possible at all. Annex I Chapter II Section 11.1 also requires that the risk of infection for patients, users and third parties be reduced as far as possible and that microbial contamination be prevented. <\/p>\n
The instructions for use are the key means of transferring requirements into clinical practice. Under Annex I Chapter III Section 23.4 point (n), cleaning, disinfection, packaging and, where applicable, the validated procedure for re-sterilisation must be described, with reference to the Member States in which the device is placed on the market, and identifiable limits of reuse must be stated, such as signs of material wear or a maximum number of permitted cycles. Point (o) requires, where applicable, a statement that reuse is permitted only after reprocessing under the manufacturer\u2019s responsibility; point (p) requires information on single-use devices. The harmonised standards EN ISO 17664-1 and EN ISO 17664-2 structure these details for critical and semi-critical, or non-critical, devices respectively. <\/p>\n
Annex VIII Chapter I Section 2.3 defines a reusable surgical instrument as an instrument for a surgical procedure without connection to an active device, whose function consists of cutting, drilling, sawing, scraping, clamping, spreading, stapling or similar, and which the manufacturer intends for reuse after cleaning, disinfection and sterilisation. Rule 6 of Annex VIII assigns these instruments to Class I, even though they are surgically invasive. <\/p>\n
However, self-certification does not apply in full here. Article 52(7) requires, for reusable surgical instruments, a procedure in accordance with Annex IX Chapters I and III or Annex XI, with the involvement of the Notified Body limited to aspects of reuse, in particular cleaning, disinfection, sterilisation, maintenance, functional testing and the associated instructions for use. For this Class I device group, the involvement of a Notified Body was new under the Regulation, which is why it is among the devices for which Article 120 provides a transitional period until 31 December 2028. <\/p>\n
The key distinction concerns Article 17. Anyone who reprocesses a single-use device so that it can be reused in the Union is deemed, under Article 17(2), to be the manufacturer of the reprocessed device and bears all manufacturer obligations, including traceability. Such reprocessing is permitted only if national law allows it; Member States may adopt stricter rules or prohibit it. For reprocessing within a health institution, Article 17(3) allows derogations if safety and performance are equivalent to the original device and the common specifications are complied with. Under Article 17(6), only single-use devices may be reprocessed that were placed on the market under the Regulation or, before 26 May 2020, under Directive 93\/42\/EEC. <\/p>\n
For a reusable device, by contrast, the original manufacturer remains responsible because reuse is part of its intended purpose and its validated reprocessing concept. Routine reprocessing in the health institution therefore follows the manufacturer\u2019s instructions and national hygiene law and does not change conformity responsibility. <\/p>\n
In investigations involving reusable devices, reprocessing is a variable in the investigation workflow. The investigation plan should specify which procedure is used for reprocessing, how cycles are documented, at which cycle stage a device is used, and how deviations are to be handled. Otherwise, it is not possible later to distinguish whether a finding results from the device, from wear, or from non-conforming reprocessing. <\/p>\n
Also relevant for clinical evidence are functional tests over the life cycle, the recording of abnormalities such as corrosion, residues or loss of function, and linking these observations to post-market surveillance. Full-service CROs such as Mediconomics support manufacturers in translating reprocessing requirements, cycle documentation and user training into investigation documentation and in systematically transferring observations from use into clinical evaluation and post-market follow-up. <\/p>\n
Where does the Regulation govern reprocessability?<\/strong><\/p>\n In Annex I Chapter II Section 11.2 for design, and in Annex I Chapter III Section 23.4 points (n) to (p) for the information in the instructions for use. Article 17 separately governs the reprocessing of single-use devices. <\/p>\n Who is responsible when a single-use device is reprocessed?<\/strong><\/p>\n Under Article 17(2), the person or institution carrying out the reprocessing is deemed to be the manufacturer of the reprocessed device and assumes the manufacturer obligations. For reprocessing within a health institution, Member States may provide derogations under Article 17(3). <\/p>\n Why is a Notified Body involved for Class I instruments?<\/strong><\/p>\n Because Article 52(7) requires involvement for reusable surgical instruments, limited to cleaning, disinfection, sterilisation, maintenance, functional testing and the associated instructions for use.<\/p>\n A reprocessable medical device is a product that the manufacturer intends for reuse after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. Regulation (EU) 2017\/745 uses the term \u201creusable device\u201d and, in Annex I Chapter II Section 11.2, sets the requirement to design devices, where necessary, so that cleaning, disinfection and […]<\/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-7780","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\/7780","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\/7780\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7780"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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