Paragraph 10 Amendment of regulation 11 (insertion of new Part IX into the 2002 Regulations)

(1)

Regulation 11 is amended as follows.

(2)

In inserted regulation 149 of the 2002 Regulations (person responsible for regulatory compliance), in paragraph (5)(e), for “Chapter II” substitute “Part 1”.

(3)

In inserted regulation 158 of the 2002 Regulations (registration of devices)—

(a)

for paragraph (1), substitute—

“(1)
Before placing a device, other than a custom-made device, on the market, the manufacturer must, in accordance with the rules of the issuing entity referred to in regulation 157(2), assign a Basic UDI-DI to the device and provide it to the UDI database together with the other core data elements referred to in—

(a)
Part B of Schedule 22 related to that device;

(b)
paragraph 2 of Part A of Schedule 22.”;

(b)

after paragraph (2), insert—

“(3)
The manufacturer must keep the information provided in accordance with paragraph (1) updated.”.