PART 1Preliminary
InterpretationI13
1
In these Regulations—
“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th 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/EEC3;
“ethics committee” means a research ethics committee recognised or established by, or on behalf of, the Scottish Ministers, the Welsh Ministers, the Department of Health in Northern Ireland or the Health Research Authority4.
2
Unless otherwise defined in these Regulations, terms used have the same meaning as in Regulation (EU) 2017/745.
3
In these Regulations a reference to—
a
an Article is a reference to an Article of Regulation (EU) 2017/745;
b
an Annex is a reference to an Annex to Regulation (EU) 2017/745.