8U.K.In this Schedule—
“[F1Schedule 13 infringement]” has the same meaning as in section 212 of the Enterprise Act 2002;
“document” includes information recorded in any form;
“enforcement order” means an order under section 217 of the Enterprise Act 2002;
“interim enforcement order” means an order under section 218 of that Act;
[F2“interim online interface order” means an order under section 218ZC of that Act;
“online interface order” means an order under section 218ZB of that Act;]
[F3“Regulation (EU) 2017/745 on medical devices” means 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.]
[F4“Regulation (EU) 2017/746 on in vitro diagnostic medical devices” means 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;]
[F5“the Regulation on Accreditation and Market Surveillance” means Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.]
[F5“the Market Surveillance Regulation” means Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011.]
Textual Amendments
F1Words in Sch. 5 para. 8 substituted (31.12.2020) by The Consumer Protection (Enforcement) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/203), regs. 1, 4(5) (with reg. 9) (as amended by S.I. 2020/1347, regs. 1(3), 3(8)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 5 para. 8 inserted (2.6.2020) by The Consumer Protection (Enforcement) (Amendment etc.) Regulations 2020 (S.I. 2020/484), regs. 1(2), 3(3) (with reg. 8)
F3Words in Sch. 5 para. 8 inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 27(2)
F4Words in Sch. 5 para. 8 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 4(a)
F5Words in Sch. 5 para. 8 substituted (N.I.) (16.7.2021) by The Market Surveillance (Northern Ireland) Regulations 2021 (S.I. 2021/858), regs. 1(1), 9(2) (with reg. 3)
Commencement Information
I1Sch. 5 para. 8 in force at 27.5.2015 for specified purposes by S.I. 2015/1333, art. 2(a)
I2 Sch. 5 para. 8 in force at 27.5.2015 for specified purposes for E. by S.I. 2015/965, art. 2(b)
I3Sch. 5 para. 8 in force at 1.10.2015 in so far as not already in force by S.I. 2015/1630, art. 3(h) (with art. 8)