http://www.legislation.gov.uk/uksi/2021/905/regulation/32The Medical Devices (Northern Ireland Protocol) Regulations 2021enMEDICAL DEVICESCONSUMER PROTECTIONStatute Law Database2024-06-12Expert Participation2024-03-21 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law. PART 8Amendment of the Medical Devices Regulations 2002Revocation and transitional provision32After regulation 3 (scope), insert—Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/7453ZA1Subject to paragraph (2)—aParts 2 and 3 only apply in Northern Ireland for the purposes of regulating qualifying devices.bParts 5 to 7 only apply in Northern Ireland for the purposes of regulating qualifying devices and devices within the scope of Part 4.2The following provisions continue to apply in Northern Ireland in accordance with this paragraph whether or not the device to which they apply is referred to in paragraph (1)—afor the purposes of registration of medical devices and persons placing medical devices on the market in Northern Ireland—iregulation 19 (registration of persons placing general medical devices on the market),iiregulation 21B (registration of persons placing active implantable medical devices on the market), andiiiregulation 53 (fees in connection with the registration of devices and changes to registration details),apply until the date which is 6 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745.bParts 5 to 7 apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.3For the purposes of paragraph (1), a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745—ait may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 93/42 or Directive 90/385, rather than Regulation (EU) 2017/745; andbit is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2, 3 and 5 to 7.Reg. 32 in force at 27.7.2021, see reg. 1(2)
This XML file does not appear to have any style information associated with it. The document tree is shown below.
<Legislation xmlns="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" DocumentURI="http://www.legislation.gov.uk/uksi/2021/905" IdURI="http://www.legislation.gov.uk/id/uksi/2021/905" NumberOfProvisions="58" xsi:schemaLocation="http://www.legislation.gov.uk/namespaces/legislation http://www.legislation.gov.uk/schema/legislation.xsd" SchemaVersion="1.0" RestrictExtent="E+W+S+N.I." RestrictStartDate="2024-03-21">
<ukm:Metadata xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata">
<dc:identifier>http://www.legislation.gov.uk/uksi/2021/905/regulation/32</dc:identifier>
<dc:title>The Medical Devices (Northern Ireland Protocol) Regulations 2021</dc:title>
<dc:language>en</dc:language>
<dc:subject scheme="SIheading">MEDICAL DEVICES</dc:subject>
<dc:subject scheme="SIheading">CONSUMER PROTECTION</dc:subject>
<dc:publisher>Statute Law Database</dc:publisher>
<dc:modified>2024-06-12</dc:modified>
<dc:contributor>Expert Participation</dc:contributor>
<dct:valid>2024-03-21</dct:valid>
<dc:description>These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law.</dc:description>
<atom:link rel="self" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.xml" type="application/xml"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/resources" href="http://www.legislation.gov.uk/uksi/2021/905/resources" title="More Resources"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/memorandum" href="http://www.legislation.gov.uk/uksi/2021/905/memorandum" title="Explanatory Memorandum"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/memorandum/toc" href="http://www.legislation.gov.uk/uksi/2021/905/memorandum/contents" title="Explanatory Memorandum Table of Contents"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/act" href="http://www.legislation.gov.uk/uksi/2021/905" title="whole act"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/introduction" href="http://www.legislation.gov.uk/uksi/2021/905/introduction" title="introduction"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/signature" href="http://www.legislation.gov.uk/uksi/2021/905/signature" title="signature"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/note" href="http://www.legislation.gov.uk/uksi/2021/905/note" title="note"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/body" href="http://www.legislation.gov.uk/uksi/2021/905/body" title="body"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/schedules" href="http://www.legislation.gov.uk/uksi/2021/905/schedules" title="schedules"/>
<atom:link rel="alternate" type="application/rdf+xml" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.rdf" title="RDF/XML"/>
<atom:link rel="alternate" type="application/akn+xml" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.akn" title="AKN"/>
<atom:link rel="alternate" type="application/xhtml+xml" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.xht" title="HTML snippet"/>
<atom:link rel="alternate" type="text/html" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.htm" title="Website (XHTML) Default View"/>
<atom:link rel="alternate" type="text/csv" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.csv" title="CSV"/>
<atom:link rel="alternate" type="application/pdf" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.pdf" title="PDF"/>
<atom:link rel="alternate" type="application/akn+xhtml" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/data.html" title="HTML5 snippet"/>
<atom:link rel="http://purl.org/dc/terms/tableOfContents" hreflang="en" href="http://www.legislation.gov.uk/uksi/2021/905/contents" title="Table of Contents"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/made" title="made"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/32/2021-07-27" title="2021-07-27"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/supersedes" href="http://www.legislation.gov.uk/id/ukdsi/2021/9780348224740" title="The Medical Devices (Northern Ireland Protocol) Regulations 2021"/>
<atom:link rel="up" href="http://www.legislation.gov.uk/uksi/2021/905" title="Entire legislation"/>
<atom:link rel="prev" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/31" title="Provision; Regulation 31"/>
<atom:link rel="prevInForce" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/31" title="Provision; Regulation 31"/>
<atom:link rel="next" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/33" title="Provision; Regulation 33"/>
<atom:link rel="nextInForce" href="http://www.legislation.gov.uk/uksi/2021/905/regulation/33" title="Provision; Regulation 33"/>
<ukm:SecondaryMetadata>
<ukm:DocumentClassification>
<ukm:DocumentCategory Value="secondary"/>
<ukm:DocumentMainType Value="UnitedKingdomStatutoryInstrument"/>
<ukm:DocumentStatus Value="revised"/>
<ukm:DocumentMinorType Value="regulation"/>
</ukm:DocumentClassification>
<ukm:Year Value="2021"/>
<ukm:Number Value="905"/>
<ukm:Made Date="2021-07-26"/>
<ukm:ComingIntoForce>
<ukm:DateTime Date="2021-07-27"/>
</ukm:ComingIntoForce>
<ukm:ISBN Value="9780348226539"/>
</ukm:SecondaryMetadata>
<ukm:Supersedes URI="http://www.legislation.gov.uk/id/ukdsi/2021/9780348224740">
<dc:title>The Medical Devices (Northern Ireland Protocol) Regulations 2021</dc:title>
<ukm:DocumentMainType Value="UnitedKingdomDraftStatutoryInstrument"/>
<ukm:Year Value="2021"/>
<ukm:ISBN Value="9780348224740"/>
</ukm:Supersedes>
<ukm:Notes>
<ukm:Note IdURI="http://www.legislation.gov.uk/id/uksi/2021/905/notes"/>
<ukm:Alternatives>
<ukm:Alternative URI="http://www.legislation.gov.uk/uksi/2021/905/pdfs/uksiem_20210905_en.pdf" Date="2021-07-26" Title="UK Explanatory Memorandum" Size="71120"/>
</ukm:Alternatives>
</ukm:Notes>
<ukm:Alternatives>
<ukm:Alternative URI="http://www.legislation.gov.uk/uksi/2021/905/pdfs/uksi_20210905_en.pdf" Date="2021-07-27" Size="121868"/>
</ukm:Alternatives>
<ukm:Statistics>
<ukm:TotalParagraphs Value="58"/>
<ukm:BodyParagraphs Value="58"/>
<ukm:ScheduleParagraphs Value="0"/>
<ukm:AttachmentParagraphs Value="0"/>
<ukm:TotalImages Value="0"/>
</ukm:Statistics>
</ukm:Metadata>
<Secondary>
<Body DocumentURI="http://www.legislation.gov.uk/uksi/2021/905/body" IdURI="http://www.legislation.gov.uk/id/uksi/2021/905/body" NumberOfProvisions="58" RestrictExtent="E+W+S+N.I." RestrictStartDate="2024-03-21">
<Part DocumentURI="http://www.legislation.gov.uk/uksi/2021/905/part/8" IdURI="http://www.legislation.gov.uk/id/uksi/2021/905/part/8" NumberOfProvisions="10" id="part-8" RestrictExtent="E+W+S+N.I." RestrictStartDate="2021-07-27">
<Number>PART 8</Number>
<Title>Amendment of the Medical Devices Regulations 2002</Title>
<P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2021-07-27">
<Title>Revocation and transitional provision</Title>
<P1 DocumentURI="http://www.legislation.gov.uk/uksi/2021/905/regulation/32" IdURI="http://www.legislation.gov.uk/id/uksi/2021/905/regulation/32" id="regulation-32">
<Pnumber>
<CommentaryRef Ref="key-3aa93da66ad630c0c5710b301ff98b5a"/>
32
</Pnumber>
<P1para>
<Text>After regulation 3 (scope), insert—</Text>
<BlockAmendment Context="unknown" TargetClass="secondary" TargetSubClass="unknown" Format="double">
<P1group>
<Title>Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745</Title>
<P1>
<Pnumber PuncAfter=".">3ZA</Pnumber>
<P1para>
<P2>
<Pnumber>1</Pnumber>
<P2para>
<Text>Subject to paragraph (2)—</Text>
<P3>
<Pnumber>a</Pnumber>
<P3para>
<Text>Parts 2 and 3 only apply in Northern Ireland for the purposes of regulating qualifying devices.</Text>
</P3para>
</P3>
<P3>
<Pnumber>b</Pnumber>
<P3para>
<Text>Parts 5 to 7 only apply in Northern Ireland for the purposes of regulating qualifying devices and devices within the scope of Part 4.</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2>
<Pnumber>2</Pnumber>
<P2para>
<Text>The following provisions continue to apply in Northern Ireland in accordance with this paragraph whether or not the device to which they apply is referred to in paragraph (1)—</Text>
<P3>
<Pnumber>a</Pnumber>
<P3para>
<Text>for the purposes of registration of medical devices and persons placing medical devices on the market in Northern Ireland—</Text>
<P4>
<Pnumber>i</Pnumber>
<P4para>
<Text>regulation 19 (registration of persons placing general medical devices on the market),</Text>
</P4para>
</P4>
<P4>
<Pnumber>ii</Pnumber>
<P4para>
<Text>regulation 21B (registration of persons placing active implantable medical devices on the market), and</Text>
</P4para>
</P4>
<P4>
<Pnumber>iii</Pnumber>
<P4para>
<Text>regulation 53 (fees in connection with the registration of devices and changes to registration details),</Text>
</P4para>
</P4>
<Text>apply until the date which is 6 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745.</Text>
</P3para>
</P3>
<P3>
<Pnumber>b</Pnumber>
<P3para>
<Text>Parts 5 to 7 apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2>
<Pnumber>3</Pnumber>
<P2para>
<Text>For the purposes of paragraph (1), a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745—</Text>
<P3>
<Pnumber>a</Pnumber>
<P3para>
<Text>it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 93/42 or Directive 90/385, rather than Regulation (EU) 2017/745; and</Text>
</P3para>
</P3>
<P3>
<Pnumber>b</Pnumber>
<P3para>
<Text>it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2, 3 and 5 to 7.</Text>
</P3para>
</P3>
</P2para>
</P2>
</P1para>
</P1>
</P1group>
</BlockAmendment>
</P1para>
</P1>
</P1group>
</Part>
</Body>
</Secondary>
<Commentaries>
<Commentary Type="I" id="key-3aa93da66ad630c0c5710b301ff98b5a">
<Para>
<Text>
Reg. 32 in force at 27.7.2021, see
<CitationSubRef id="n6de5858563e72909" SectionRef="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2021/905/regulation/1/2" Operative="true">reg. 1(2)</CitationSubRef>
</Text>
</Para>
</Commentary>
</Commentaries>
</Legislation>