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
— Australia
— New Zealand
— Canada
— The United States of America
— The Swiss Confederation