Regulation 40 Designation of UK notified bodiesF1
Northern Ireland
The Secretary of State may designate a person to carry out conformity assessment (a “notified body designation”).
A person in respect of whom a notified body designation has been made is a UK notified body to the extent that the designation remains in effect provided that—
the designation has been notified by the Secretary of State to the European Commission and the other F2relevant states,
in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—
the person designated is established in the United Kingdom; or
an accreditation certificate attesting that the person meets the requirements laid down in paragraphs 2 to 11 of Article 26 of the Directive was issued by the United Kingdom Accreditation Service, in respect of that person.
A person wishing to be a UK notified body must apply to the Secretary of State for designation.
A notified body designation must not be made unless the Secretary of State is satisfied that the person meets the requirements laid down in paragraphs 2 to 11 of Article 26 of the Directive (the “notified body criteria”).
A person who meets the relevant assessment criteria laid down in a harmonised standard shall be presumed to meet that part of the notified body criteria which corresponds to the criteria in that standard.
The presumption of compliance in paragraph (5) is rebuttable.
A notified body designation—
must be in writing;
must specify the conformity assessment procedures that the person designated may carry out;
may designate a person for a specified period; and
may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.
In making a notified body designation the Secretary of State may have regard (in addition to the notified body criteria) to any other matter which appears to the Secretary of State to be relevant.
A UK notified body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the notified body criteria, these Regulations, or any condition to which its designation is subject.
Annotations
Textual amendments
- F1
Pt. 3 (regs. 40A-41) substituted for Pt. 3 (regs. 40, 41) (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 15 para. 28 (with Sch. 15 para. 3) (as amended by S.I. 2020/676, regs. 1(1), 2; by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 9(5) and by S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(e)(vii)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 40(2) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 5 para. 4(a)
- F3
Words in reg. 40(2)(b) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 5 para. 4(b)(i)
- F4
Word in reg. 40(2)(b) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 5 para. 4(b)(ii)
- F5
Word in reg. 40(2)(b) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 5 para. 4(b)(iii)
- F6
Reg. 40(2)(c) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 5 para. 4(c)
Notes on Part 3
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only