The Measuring Instruments Regulations 2016

[F1 MODULE F: E+W+S CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

Textual Amendments

F1 Schs. 1A-1K inserted (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. 27 para. 49 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

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 paragraphs 2, 5.1 and 6, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them. E+W+S

Manufacturing E+W+S

2.   The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured regulated measuring instruments with the approved type described in the type examination certificate and with the requirements of these Regulations that apply to them.

Verification E+W+S

3.   An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the instruments with the type as described in the type examination certificate and the appropriate requirements of these Regulations.

The examinations and tests to verify the conformity of the regulated measuring instruments with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph 4, or by examination and testing of the regulated measuring instruments on a statistical basis as specified in paragraph 5.

4.   Verification of conformity by examination and testing of every instrument E+W+S

4.1.   All regulated measuring instruments shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the type examination certificate and with the appropriate requirements of these Regulations. E+W+S

In the absence of a designated standard or normative document, the approved body concerned shall decide on the appropriate tests to be carried out.

4.2.   The 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 instrument or have it affixed under its responsibility. E+W+S

The manufacturer shall keep the certificates of conformity available for inspection by the market surveillance authorities for 10 years after the instrument has been placed on the market.

Statistical verification of conformity E+W+S

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 regulated measuring instruments for verification in the form of homogeneous lots. E+W+S

5.2.   A random sample shall be taken from each lot according to the requirements of paragraph 5.3. All regulated measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the type examination certificate and with the applicable requirements of these Regulations, and to determine whether the lot is accepted or rejected. In the absence of such designated standard or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. E+W+S

5.3.   The statistical procedure shall meet the following requirements: E+W+S

The statistical control will be based on attributes. The sampling system shall ensure:

(a) a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %;

(b) a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %.

5.4.   If a lot is accepted, all regulated measuring instruments of the lot shall be considered approved, except for those regulated measuring instruments from the sample that have been found not to satisfy the tests. E+W+S

The 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 instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

5.5.   If a lot is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the approved body may suspend the statistical verification and take appropriate measures. E+W+S

Conformity marking and declaration of conformity E+W+S

6.1.   The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual instrument that is in conformity with the approved type described in the type examination certificate and satisfies the applicable requirements of these Regulations. E+W+S

6.2.   The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. E+W+S

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the regulated measuring instruments.

7.   If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the regulated measuring instruments during the manufacturing process. E+W+S

Authorised representative E+W+S

8.   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 paragraphs 2 and 5.1.]