<akomaNtoso xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xsi:schemaLocation="http://docs.oasis-open.org/legaldocml/ns/akn/3.0 http://docs.oasis-open.org/legaldocml/akn-core/v1.0/cos01/part2-specs/schemas/akomantoso30.xsd"><act name="eur"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eur/2017/746"/><FRBRuri value="http://www.legislation.gov.uk/id/eur/2017/746"/><FRBRdate date="2017-04-05" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="746"/><FRBRname value="Regulation (EU) 2017/746"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eur/2017/746/2020-12-31"/><FRBRuri value="http://www.legislation.gov.uk/eur/2017/746/2020-12-31"/><FRBRdate date="2020-12-31" name="validFrom"/><FRBRauthor href="#"/><FRBRlanguage language="eng"/></FRBRExpression><FRBRManifestation><FRBRthis value="http://www.legislation.gov.uk/eur/2017/746/2020-12-31/data.akn"/><FRBRuri value="http://www.legislation.gov.uk/eur/2017/746/2020-12-31/data.akn"/><FRBRdate date="2026-08-18+01:00" name="transform"/><FRBRauthor href="http://www.legislation.gov.uk"/><FRBRformat value="application/akn+xml"/></FRBRManifestation></identification><lifecycle source="#"><eventRef refersTo="#adopted" date="2017-04-05" eId="date-adopted" source="#"/><eventRef date="2020-12-31" eId="date-2020-12-31" source="#"/></lifecycle><analysis source="#"><restrictions source="#"><restriction refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#body" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#chapter-II" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#article-8" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction refersTo="#period-from-2020-12-31" type="jurisdiction"/><restriction href="#body" refersTo="#period-from-2020-12-31" type="jurisdiction"/><restriction href="#chapter-II" refersTo="#period-from-2020-12-31" type="jurisdiction"/><restriction href="#article-8" refersTo="#period-from-2020-12-31" type="jurisdiction"/></restrictions><otherAnalysis source=""><uk:status href="#body" refersTo="#status-repealed"/><uk:status href="#chapter-II" refersTo="#status-repealed"/><uk:status href="#article-8" refersTo="#status-repealed"/><uk:match href="#body" value="false"/><uk:match href="#chapter-II" value="false"/><uk:match href="#article-8" value="false"/><uk:commentary href="#act" refersTo="#key-f0fe3e1a362a57117977e93ea17feacd"/><uk:commentary href="#article-8" refersTo="#key-f0fe3e1a362a57117977e93ea17feacd"/></otherAnalysis></analysis><temporalData source="#"><temporalGroup eId="period-from-2020-12-31"><timeInterval start="#date-2020-12-31" refersTo="#"/></temporalGroup></temporalData><references source="#"><TLCEvent eId="adopted" href="" showAs="AdoptedDate"/><TLCLocation eId="extent-e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="E+W+S+N.I."/><TLCConcept eId="status-repealed" href="" showAs="Repealed"/></references><notes source="#"><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-f0fe3e1a362a57117977e93ea17feacd" marker="F1"><p>Regulation revoked (31.12.2020) by <ref eId="d10e2" href="http://www.legislation.gov.uk/id/uksi/2002/618">The Medical Devices Regulations 2002 (S.I. 2002/618)</ref>, <ref eId="ccd8e520230223114700914Z" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2002/618/regulation/4P">reg. 4P</ref> (as inserted by <ref eId="d10e8" href="http://www.legislation.gov.uk/id/uksi/2019/791">S.I. 2019/791</ref>, <ref eId="ccd8e1120230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/1/1">regs. 1(1)</ref>, <ref eId="ccd8e1420230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/3/7">3(7)</ref> (as amended by <ref eId="d10e18" href="http://www.legislation.gov.uk/id/uksi/2020/1478">S.I. 2020/1478</ref>, <ref eId="ccd8e2120230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/regulation/1/3">regs. 1(3)</ref>, <ref eId="ccd8e2420230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/schedule/2/paragraph/2">Sch. 2 paras. 2</ref>, <ref eId="ccd8e2720230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/schedule/2/paragraph/9/m">9(m)</ref>); <ref eId="d10e30" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="ccd8e3320230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>)</p></note><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-f0fe3e1a362a57117977e93ea17feacd" marker="F2"><p>Regulation revoked (31.12.2020) by <ref eId="d10e2" href="http://www.legislation.gov.uk/id/uksi/2002/618">The Medical Devices Regulations 2002 (S.I. 2002/618)</ref>, <ref eId="ccd8e520230223114700914Z" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2002/618/regulation/4P">reg. 4P</ref> (as inserted by <ref eId="d10e8" href="http://www.legislation.gov.uk/id/uksi/2019/791">S.I. 2019/791</ref>, <ref eId="ccd8e1120230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/1/1">regs. 1(1)</ref>, <ref eId="ccd8e1420230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/3/7">3(7)</ref> (as amended by <ref eId="d10e18" href="http://www.legislation.gov.uk/id/uksi/2020/1478">S.I. 2020/1478</ref>, <ref eId="ccd8e2120230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/regulation/1/3">regs. 1(3)</ref>, <ref eId="ccd8e2420230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/schedule/2/paragraph/2">Sch. 2 paras. 2</ref>, <ref eId="ccd8e2720230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1478/schedule/2/paragraph/9/m">9(m)</ref>); <ref eId="d10e30" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="ccd8e3320230223114700914Z" class="subref" href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>)</p></note></notes><proprietary xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" source="#"><dc:identifier>http://www.legislation.gov.uk/eur/2017/746/article/8</dc:identifier><dc:title>Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) (revoked)</dc:title><dct:alternative>Regulation (EU) 2017/746 of the European Parliament and of the Council</dct:alternative><dc:description>Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)</dc:description><dc:publisher>King's Printer of Acts of Parliament</dc:publisher><dc:source>https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20170505</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2024-04-02</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2020-12-31</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionRegulation"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2017"/><ukm:Number Value="746"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="83c95e6c-ba23-4724-aa4c-13a8940d5d91"/><ukm:ELI Value="reg:2017:746:2017-05-05"/><ukm:CELEX Value="02017R0746-20170505"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2017-04-05"/><ukm:EURLexModified Date="2020-02-27T20:49:10Z"/><ukm:EURLexExtracted Date="2020-02-27T22:02:14Z"/><ukm:XMLGenerated Date="2020-12-12T17:47:50Z"/><ukm:XMLImported Date="2020-12-12T23:24:39Z"/><ukm:CreatedBy Label="Provisional data" URI="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="true"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2017/746/pdfs/eur_20170746_adopted_en.pdf" Date="2017-04-05" Size="1475261"/><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2017/746/pdfs/eur_20170746_2017-05-05_en.pdf" Date="2017-05-05" Size="1491933" Revised="2017-05-05"/></ukm:Alternatives><ukm:CorrectionSlips><ukm:CorrectionSlip URI="http://www.legislation.gov.uk/eur/2017/746/pdfs/eurcs_20170746_en_001.pdf" Date="2019-05-03" Size="492066"/><ukm:CorrectionSlip URI="http://www.legislation.gov.uk/eur/2017/746/pdfs/eurcs_20170746_en_002.pdf" Date="2019-12-27" Size="575369"/></ukm:CorrectionSlips><ukm:Statistics><ukm:TotalParagraphs Value="395"/><ukm:BodyParagraphs Value="113"/><ukm:ScheduleParagraphs Value="282"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><chapter eId="chapter-II"><num><noteRef href="#key-f0fe3e1a362a57117977e93ea17feacd" uk:name="commentary" ukl:Name="CommentaryRef" class="commentary"/>CHAPTER II</num><heading><b>MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT</b></heading><article eId="article-8" uk:target="true"><num><noteRef href="#key-f0fe3e1a362a57117977e93ea17feacd" uk:name="commentary" ukl:Name="CommentaryRef" class="commentary"/>Article 8</num><heading>Use of harmonised standards</heading><content><p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p></content></article></chapter></body></act></akomaNtoso>