Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))

http://www.legislation.gov.uk/eur/2017/745/annex/XI/part/A/division/6Regulation (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 (Text with EEA relevance) (revoked)Regulation (EU) 2017/745 of the European Parliament and of the CouncilRegulation (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 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424texttext/xmlen2024-04-02Expert Participation2020-12-31ANNEXESANNEX XICONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATIONPART APRODUCTION QUALITY ASSURANCE6.Quality management system6.1.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.2.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.3.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.4.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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<p>
Regulation revoked (31.12.2020) by
<ref href="http://www.legislation.gov.uk/id/uksi/2002/618">The Medical Devices Regulations 2002 (S.I. 2002/618)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2002/618/regulation/4O">reg. 4O</ref>
(with savings and transitional provisions for N.I. in
<ref href="http://www.legislation.gov.uk/id/uksi/2002/618/regulation/3ZA">reg. 3ZA</ref>
) (as amended by
<ref href="http://www.legislation.gov.uk/id/uksi/2019/791">S.I. 2019/791</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/1/1">regs. 1(1)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/791/regulation/3/7">3(7)</ref>
and by
<ref href="http://www.legislation.gov.uk/id/uksi/2020/1478">S.I. 2020/1478</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2020/1478/regulation/1/3">regs. 1(3)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2020/1478/schedule/2/paragraph/2">Sch. 2 para. 2</ref>
; and as amended (27.7.2021) by
<ref href="http://www.legislation.gov.uk/id/uksi/2021/905">The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2021/905/regulation/1/2">regs. 1(2)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2021/905/regulation/4">4</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2021/905/regulation/32">32</ref>
);
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
)
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