Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

5. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION U.K.

5.1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.5.1 and 5.6, and ensures and declares on his sole responsibility that the appliances or fittings concerned, which have been subject to point 5.3, are in conformity with the type described in the F1 ... type-examination certificate and satisfy the requirements of this Regulation that apply to them. U.K.

Textual Amendments

F1 Word in Annex 3 para. 5.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.2. Manufacturing U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the approved type described in the F2 ... type-examination certificate and with the requirements of this Regulation that apply to them.

Textual Amendments

F2 Word in Annex 3 para. 5.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.3. Verification U.K.

[F3 An approved] body chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the appliances or fittings with the approved type described in the F4 ... type-examination certificate and with the appropriate requirements of this Regulation.

Textual Amendments

F3 Words in Annex 3 para. 5.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(dd) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Annex 3 para. 5.3 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

The examinations and tests to check the conformity of the appliances or fittings with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every appliance or fitting as specified in point 5.4 or by examination and testing of the appliances or fittings on a statistical basis as specified in point 5.5.

5.4. Verification of conformity by examination and testing of every appliance or fitting U.K.

5.4.1. All appliances or fittings shall be individually examined and appropriate tests set out in the relevant [F5 designated] standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the F6 ... type-examination certificate and with the appropriate requirements of this Regulation. U.K.

Textual Amendments

F5 Word in Annex 3 para. 5.4.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ee) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Annex 3 para. 5.4.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

In the absence of such a [F5 designated] standard, the [F7 approved] body concerned shall decide on the appropriate tests to be carried out.

Textual Amendments

F7 Word in Annex 3 para. 5.4.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.4.2. The [F8 approved] body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility. U.K.

Textual Amendments

F8 Word in Annex 3 para. 5.4.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

The manufacturer shall keep the certificates of conformity available for inspection by the [F9 enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

F9 Words in Annex 3 para. 5.4.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(gg) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.5. Statistical verification of conformity U.K.

5.5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his appliances or fittings for verification in the form of homogeneous lots. U.K.

5.5.2. A random sample shall be taken from each lot in accordance with the requirements of point 5.5.3. All appliances or fittings in a sample shall be individually examined and appropriate tests set out in the relevant [F10 designated] standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a [F10 designated] standard, the [F11 approved] body concerned shall decide on the appropriate tests to be carried out. U.K.

Textual Amendments

F10 Word in Annex 3 para. 5.5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ee) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Annex 3 para. 5.5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.5.3. The [F12 approved] body shall apply a sampling system with the following characteristics: U.K.

Textual Amendments

F12 Word in Annex 3 para. 5.5.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

• a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 % and 1,5 %,

• a limit quality corresponding to a probability of acceptance of 5 % with a non-conformity percentage of between 5 % and 10 %.

5.5.4. If a lot is accepted, all appliances or fittings of the lot shall be considered approved, except for those appliances or fittings from the sample that have been found not to satisfy the tests. U.K.

The [F13 approved] body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility.

Textual Amendments

F13 Word in Annex 3 para. 5.5.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

The manufacturer shall keep the certificates of conformity at the disposal of the [F14 enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

F14 Words in Annex 3 para. 5.5.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(hh) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.5.5. If a lot is rejected, the [F15 approved] body or the [F16 enforcement authority] shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots the [F15 approved] body may suspend the statistical verification and take appropriate measures. U.K.

Textual Amendments

F15 Word in Annex 3 para. 5.5.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Annex 3 para. 5.5.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ii) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.6. [F17 UK] marking and F18 ... declaration of conformity U.K.

5.6.1. The manufacturer shall affix the [F19 UK] marking and, under the responsibility of the [F20 approved] body referred to in point 5.3, the latter's identification number to each individual appliance or fitting that is in conformity with the approved type described in the F21 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F19 Word in Annex 3 para. 5.6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(jj) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F20 Word in Annex 3 para. 5.6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F21 Word in Annex 3 para. 5.6.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.6.2. The manufacturer shall draw up a written F22 ... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F23 enforcement authority], for 10 years after the appliance or the fitting has been placed on the market. The F22 ... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. U.K.

Textual Amendments

F22 Word in Annex 3 para. 5.6.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Annex 3 para. 5.6.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(kk)(i) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

A copy of the F22 ... declaration of conformity shall be made available to the [F24 enforcement authority] upon request. A copy of the F22 ... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

F24 Words in Annex 3 para. 5.6.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(kk)(ii) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

If the [F25 approved] body referred to in point 5.3 agrees and under its responsibility, the manufacturer may also affix the [F25 approved] body's identification number to the appliance or the fitting.

Textual Amendments

F25 Word in Annex 3 para. 5.6.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F17 Word in Annex 3 para. 5.6 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(jj) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Annex 3 para. 5.6 heading omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(cc) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.7. If the [F26 approved] body agrees and under its responsibility, the manufacturer may affix the [F26 approved] body's identification number to the appliances or the fittings during the manufacturing process. U.K.

Textual Amendments

F26 Word in Annex 3 para. 5.7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(ff) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.8. Authorised representative U.K.

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 5.2 and 5.5.1.