SCHEDULE 2 Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Insertion of regulation 6(4B)

39.  After regulation 6(4A) insert—

“(4B) For regulation 37 (CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive) substitute—

“UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation

37.   Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.”.”.