Interpretation
3.—(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/EEC(1);
“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 Authority(2).
(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.
OJ No. L 117, 05.05.2017, p. 1., amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020, OJ No. L 130, 24.04.2020, p.18.
The Health Research Authority is established by section 109 of the Care Act 2014 (c.23).