PART 1Amendment of the 2002 Regulations
Amendment of Part V of the 2002 RegulationsI1F17
1
Part V of the 2002 Regulations is amended as follows.
2
In the Part V heading for “Notified Bodies” substitute “Approved Bodies”.
3
Before regulation 45 insert—
Meaning of approved body and UK notified bodyA45
1
An approved body is a conformity assessment body which—
a
has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or
b
immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.
2
In this regulation—
“UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”.
4
In regulation 45 (designation etc. of UK notified bodies)—
a
in the heading for “UK notified bodies” substitute “approved bodies”;
b
in paragraph (1)—
i
for “article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79” substitute “these Regulations”;
ii
for “a notified body” substitute “an approved body”;
iii
for “a “UK notified body”” substitute “an “approved body””;
c
in the opening words of paragraph (2) for “a notified body” substitute “an approved body”;
d
in paragraph (2)(a)—
i
for “Directive 90/385” substitute “Part III”;
ii
for “notified bodies set out in Annex 8 of that Directive” substitute “approved bodies set out in Annex 8 of Directive 90/385”;
e
in paragraph (2)(b)—
i
for “Directive 93/42” substitute “Part II”;
ii
for “notified bodies set out in Annex XI of that Directive” substitute “approved bodies set out in Annex XI of Directive 93/42”;
f
in paragraph (2)(c)—
i
for “Directive 98/79” substitute “Part IV”;
ii
for “notified bodies set out in Annex IX of that Directive” substitute “approved bodies set out in Annex IX of Directive 98/79”;
g
in paragraph (2)(d) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
h
in paragraph (4) for “a UK notified body” substitute “an approved body”;
i
in paragraph (5)(c) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
j
in paragraph (6)—
i
for “the notified body’s request” substitute “the approved body’s request”;
ii
for “notified body” substitute “approved body”;
k
in paragraph (7), in the opening words, for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
l
in paragraph (8)—
i
in the opening words for “a UK notified body” substitute “an approved body”;
ii
in sub-paragraph (b) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.
5
In regulation 46 (choice of notified bodies and conformity assessment bodies)—
a
for the heading substitute “Choice of approved bodies and conformity assessment bodies”;
b
for “a notified body” substitute “an approved body”
c
for “his authorised representative” substitute “the manufacturer’s UK responsible person”;
d
for “any notified body” substitute “any approved body”.
6
In regulation 47 (general matters relating to UK notified bodies)—
a
for the heading substitute “General matters relating to approved bodies”;
b
in paragraph (1)—
i
for “A UK notified body” substitute “An approved body”;
ii
for “his authorised representative” substitute “the manufacturer’s UK responsible person”;
iii
for “a notified body” substitute “an approved body”;
iv
for “the Medical Devices Directives” substitute “these Regulations”;
c
in paragraph (2)—
i
for “his authorised representative” substitute “the manufacturer’s UK responsible person”;
ii
for “a UK notified body” substitute “an approved body”;
d
in paragraph (3)—
i
for “his authorised representative supplies to a notified body” substitute “the manufacturer’s UK responsible person supplies to an approved body”;
ii
for “the Medical Devices Directives” substitute “these Regulations”;
iii
omit “if the notified body is within the United Kingdom”;
iv
omit “or some other Community language acceptable to the notified body concerned”;
e
in paragraph (4)—
i
for “A UK notified body” substitute “An approved body”;
ii
for “other notified bodies” substitute “other approved bodies”;
f
in paragraph (5)—
i
in the opening words for “a UK notified body” substitute “an approved body”;
ii
in sub-paragraph (a) for “the Medical Devices Directives” substitute “these Regulations”;
iii
in the words after sub-paragraph (b) for “notified body”, both times those words occur, substitute “approved body”;
g
in paragraph (6)—
i
for “a UK notified body” substitute “an approved body”;
ii
for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”;
h
in paragraph (8)—
i
for “A UK notified body” substitute “an approved body”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.
7
After regulation 47 insert—
Register of approved bodies47A
1
The Secretary of State must ensure that—
a
each approved body is assigned an identification number; and
b
there is a register of—
i
approved bodies;
ii
their approved body identification number;
iii
the tasks for which they have been designated; and
iv
any restrictions on those tasks.
2
The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.
3
The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).
8
In regulation 48 (designation etc. of EC conformity assessment bodies)—
a
in the heading omit “EC”;
b
in paragraph (1)—
i
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
ii
omit “European Community”;
iii
for “an “EC CAB”” substitute “a “CAB””;
c
in paragraph (2)—
i
for “an EC CAB” in both places substitute “a CAB”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
d
in paragraph (4) for “an EC CAB” substitute “a CAB”;
e
in paragraph (5)(b)—
i
for “an EC CAB” substitute “a CAB”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
f
in paragraph (6) omit “EC” in both places;
g
in paragraph (7), in the opening words—
i
for “an EC CAB” substitute “a CAB”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
h
in paragraph (8)—
i
for “an EC CAB” in both places substitute “a CAB”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”.
9
In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)—
a
for the heading substitute “Fees charged by approved bodies and conformity assessment bodies”;
b
in paragraph (1), in the opening words for “A UK notified body or EC CAB” substitute “An approved body or CAB”;
c
for paragraph (1)(a) substitute—
a
in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and
d
in paragraph (1)(b)—
i
for “an EC CAB” in both places it occurs substitute “a CAB”;
ii
for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;
e
in paragraph (3)—
i
in the opening words for “UK notified body or EC CAB” substitute “approved body or CAB”;
ii
in sub-paragraph (a) for “notified body” substitute “approved body”;
f
in paragraph (4) for “UK notified body or EC CAB” substitute “approved body or CAB”.
10
In regulation 50 (products incorrectly marked with a notified body or conformity assessment body number)—
a
in the heading for “a notified body” substitute “an approved body”;
b
in paragraph (1) for “a notified body” in each place it occurs substitute “an approved body”;
c
in paragraph (2)—
i
for “a notified body” each place it occurs substitute “an approved body”;
ii
in sub-paragraph (b) for “the notified body” substitute “the approved body”;
d
in paragraph (3)(a) for “a notified body” substitute “an approved body”;
e
in paragraph (3)(b) for “notified body” in both places substitute “approved body”;
f
in paragraph (4) for “a notified body” substitute “an approved body”.
11
In regulation 51 (products incorrectly marked with a CE marking) and in the heading, for “CE marking” in each place it occurs substitute “UK marking”.