Paragraph 8 I1I2I3

In this Schedule—

• F1...

• “document” includes information recorded in any form;

• “enforcement order” means an order under F2section 156 of the Digital Markets, Competition and Consumers Act 2024;

• F3“final enforcement notice” means a notice under paragraph 16C(2) of this Schedule;

• F4“firm” means any entity, whether or not a legal person, that is not an individual and includes a body corporate, a corporation sole and a partnership or other unincorporated association;

• “interim enforcement order” means an order under F5section 159 of that Act;

• F6“interim online interface order” means an order under F7section 162 of that Act;

• “online interface order” means an order under F8section 161 of that Act;

• F9“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.

• F10“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;

• F11“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.

• “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;

• “relevant notice” has the same meaning as in section 202(9) of the Digital Markets, Competition and Consumers Act 2024.