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”.