PART 2Amendments to primary legislation

Amendment to the Human Tissue Act 20043

In section 13 of the Human Tissue Act 20044 (authorisation of activities for scheduled purposes), in subsection (12), for paragraph (a), substitute—

a

the use of relevant material to the extent that such use is regulated by—

i

the Medical Devices Regulations 2002 (S.I. 2002/618),

ii

Regulation (EU) 2017/7455 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, or

iii

Regulation (EU) 2017/7466 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, or