PART 1Amendment of the 2002 Regulations

Amendment of Part VII of the 2002 RegulationsI19

1

Part VII of the 2002 Regulations is amended as follows.

2

In regulation 59 M1(interpretation of Part VII)—

a

omit the definition of “registrable device”;

b

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

3

M2In regulation 60 (designation etc. of authorised representatives)—

a

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

b

omit paragraphs (1) and (2);

c

for paragraph (3), substitute—

3

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.

F2d

in paragraph (4)—

i

for “an authorised representative of a manufacturer of a device” substitute “ a UK responsible person ”;

ii

for “the single authorised representative of the manufacturer” substitute “ a UK responsible person ”.

F34

In regulation 61 (enforcement etc.)—

a

for “CE marking” in both places substitute “UK marking”;

b

in paragraph (8)(a)(i), after “essential requirement” insert “, a general safety and performance requirement”;

c

in paragraph (8)(a)(ii), omit “set out in the Medical Devices Directives”;

d

in paragraph (8)(a)(ii)(aa), for “his authorised representative” substitute “their UK responsible person”.

5

In regulation 62 (compliance notices) in paragraph (1)—

i

after “performance evaluation” insert “ or study ”;

ii

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

F4iii

in sub-paragraph (c) omit “and, where applicable any relevant provision of the Medical Devices Directives”.

6

In regulation 63 M3 (restriction notices) in paragraph (1)—

i

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

ii

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

F16A

In regulation 64 (notification of decisions etc)—

a

in paragraph (1)(c), for “him or his authorised representative” substitute “the applicant or the applicant’s UK responsible person”;

b

in paragraph (2)—

i

for “a UK notified body” substitute “an approved body”;

ii

for “his authorised representative” substitute “their UK responsible person”.

7

Omit regulation 65(centralised system of records etc.).

8

In regulation 67 M4 (review), for “2019” substitute “ 2025 ”.

9

Omit Schedule 1 M5 (association agreements).

10

For Schedule 2 M6 (mutual recognition agreements) substitute—

SCHEDULE 2Mutual Recognition Agreement countries

Regulation 1A

  • — Australia

  • — New Zealand

  • — Canada

  • — The United States of America

  • — The Swiss Confederation