PART VF23Notified BodiesF23Approved Bodies, Conformity Assessment Bodies and Marking of Products
Designation etc. of F27approved bodiesE245
1
The Secretary of State may designate for the purposes of F13these Regulations any corporate or other body as a body which is to carry out any of the tasks of F3an approved body, and, if he so designates a body (referred to in these Regulations as F21an “approved body”), he shall designate the tasks which it is to carry out.
2
A body may be designated under paragraph (1) as a body which is to carry out tasks of F8an approved body only if—
a
b
c
d
in so far as it needs to be able to fulfil the functions of an importing Party arising out of F15a mutual recognition agreement, it is able to do so.
3
The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.
4
The Secretary of State may vary the tasks that F16an approved body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.
5
The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—
a
the body so requests;
b
he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F18both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; or
c
he considers that the body is not capable of fulfilling the functions of an importing Party arising out of F10a mutual recognition agreement which it needs to be able to fulfil,
and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.
6
Before—
a
effecting a variation under paragraph (4); or
b
restricting or withdrawing a designation under paragraph (5),
7
For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F20both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of F2a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—
a
any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or
b
any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,
and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.
8
The Secretary of State may request that F9an approved body supply to him any or all relevant information and documents, including budgetary documents, necessary—
a
to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F11both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; or
b
for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of F24a mutual recognition agreement which it needs to be able to fulfil,
and the body shall supply to him any and all relevant information or documents so requested.
Designation etc. of UK notified bodiesE145
1
The Secretary of State may designate for the purposes of article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79 any corporate or other body as a body which is to carry out any of the tasks of a notified body F5with respect to devices to be placed on the market in Northern Ireland, and, if he so designates a body (referred to in these Regulations as a “UK notified body”), he shall designate the tasks which it is to carry out.
2
A body may be designated under paragraph (1) as a body which is to carry out tasks of a notified body only if—
a
in so far as it is to be designated as a body which is to carry out tasks included in Directive 90/385, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex 8 of that Directive F30, read with Regulation (EU) No 722/2012, are met;
b
c
in so far as it is to be designated as a body which is to carry out tasks included in Directive 98/79, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex IX of that Directive are met; and
d
in so far as it needs to be able to fulfil the functions of an importing Party arising out of the Mutual Recognition Agreements, it is able to do so.
3
The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.
4
The Secretary of State may vary the tasks that a UK notified body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.
5
The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—
a
the body so requests;
b
he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F32both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; or
c
he considers that the body is not capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,
and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.
6
Before—
a
effecting a variation under paragraph (4); or
b
restricting or withdrawing a designation under paragraph (5),
otherwise than at the notified body’s request, the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.
7
For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F29both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—
a
any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or
b
any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,
and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.
8
The Secretary of State may request that a UK notified body supply to him any or all relevant information and documents, including budgetary documents, necessary—
a
to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, F31both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; or
b
for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,
and the body shall supply to him any and all relevant information or documents so requested.
Words in Pt. 5 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)