Regulation 9 Amendment of Part VII of the 2002 Regulations

omit the definition of “registrable device”;

in the definition of “relevant device” after “IV” insert “or a device for the purposes of Part VIII or IX.”.

for the heading substitute “Status of UK responsible person”;

omit paragraphs (1) and (2);

for paragraph (3), substitute—

“A UK responsible person—

(a)

may be proceeded against as a person placing the device on the market for the purposes of these regulations;

(b)

in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.”.

in paragraph (4), for “an authorised representative” substitute “a UK responsible person”.

in paragraph (8) in sub-paragraph (a)—

in sub-paragraph (b), after “performance evaluation” insert “or study”.

after “performance evaluation” insert “or study”;

for “the manufacturer or his authorised representative” substitute “any person”.

in sub-paragraph (a), after “performance evaluation” insert “or study”;

in sub-paragraph (b), after “performance evaluation” insert “or study”.