The Non-automatic Weighing Instruments Regulations 2016

CHAPTER 1 OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS MANUFACTURERS

Introductory

5.—(1) This Chapter applies in relation to the placing on the market of a regulated non-automatic weighing instrument by a manufacturer.

(2) The obligations in this Chapter also apply to an importer or distributor who—

(a) places a regulated non-automatic weighing instrument on the market under the name or trade mark of that importer or distributor; or

(b) modifies a regulated non-automatic weighing instrument already placed on the market in such a way that compliance with these Regulations may be affected,

and the expression “manufacturer” is to be construed accordingly.

Manufacturers’ responsibilities – design, conformity assessment and marking of regulated non-automatic weighing instruments

6.  A manufacturer must not place on the market a regulated non-automatic weighing instrument unless the manufacturer has—

(a) designed and manufactured the instrument in accordance with the essential requirements;

(b) drawn up technical documentation in relation to the instrument;

(c) carried out (or procured the carrying out of) the relevant conformity assessment procedure which has demonstrated compliance of the instrument with the applicable requirements;

(d) drawn up an EU declaration of conformity; and

(e) affixed to the instrument—

(i) the CE marking; and

(ii) the M marking.

Manufacturers’ obligations in respect of records

7.  A manufacturer must keep the technical documentation and the EU declaration of conformity for a period of 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument to which it relates has been placed on the market.

Manufacturers’ obligations to ensure continuing conformity with the essential requirements

8.—(1) Manufacturers must have procedures in place for series production of regulated non-automatic weighing instruments by them to ensure that instruments so manufactured continue to meet the essential requirements.

(2) These procedures must adequately take into account changes in—

(a) regulated non-automatic weighing instrument design or characteristics; and

(b) changes in the harmonised standards or in other technical specifications by reference to which the conformity of the regulated non-automatic weighing instrument is declared.

(3) When deemed appropriate with regard to the risks presented by the use of a regulated non-automatic weighing instrument, a manufacturer must—

(a) carry out sample testing of regulated non-automatic weighing instruments made available by the manufacturer on the market;

(b) investigate complaints about regulated non-automatic weighing instruments made available by the manufacturer on the market;

(c) if necessary, keep a register of—

(i) such complaints;

(ii) non-conforming regulated non-automatic weighing instruments; and

(iii) regulated non-automatic weighing instrument recalls; and

(d) keep distributors informed of any monitoring action the manufacturer has undertaken.

Manufacturers’ obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.

9.—(1) A manufacturer must ensure that a regulated non-automatic weighing instrument, which that manufacturer has placed on the market, bears a type, batch, serial number or other element allowing identification of the instrument.

(2) A manufacturer must ensure that a regulated non-automatic weighing instrument is marked with the information specified in Schedule 1 (information to be marked on regulated non-automatic weighing instruments) and in the manner required by that Schedule.

(3) Where a regulated non-automatic measuring instruments includes or is attached to devices which are not used or intended to be used for any of the purposes listed in regulation 3(2), the manufacturer must affix to those devices a symbol constituted by a capital letter (M) printed in black on a red background at least 25mm x 25mm square with two intersecting diagonals forming a cross.

(4) The symbol referred to in paragraph (3) must be affixed in a clearly visible and indelible form.

Manufacturers to mark contact details on regulated non-automatic weighing instruments

10.—(1) A manufacturer must indicate on every regulated non-automatic weighing instruments manufactured by that manufacturer, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which the manufacturer can be contacted.

(2) The address required by these Regulations must indicate a single point at which the manufacturer can be contacted.

(3) The contact details required by this regulation must be in a language that is easily understood by end-users and market surveillance authorities and in the case of regulated non-automatic weighing instruments made available in the United Kingdom, they must be in English.

Documentation to accompany regulated non-automatic weighing instruments

11.—(1) A manufacturer must ensure that regulated non-automatic weighing instruments manufactured by that manufacturer are accompanied by instructions and information easily understood by end-users.

(2) Where end-users are in the United Kingdom, those instructions and information must be in English.

(3) Such instructions and information and any labelling relating to a regulated non-automatic weighing instrument must be clear, understandable and intelligible.

Action to be taken where regulated non-automatic weighing instruments placed on the market are not in conformity with the essential requirements

12.—(1) This regulation applies where a manufacturer considers or has reason to believe that a regulated non-automatic weighing instrument placed on the market by that manufacturer is not in conformity with the requirements of these Regulations.

(2) The manufacturer must immediately take the corrective measures necessary to bring the regulated non-automatic weighing instrument into conformity, or withdraw or recall it, if appropriate.

(3) Where the regulated non-automatic weighing instrument presents a risk, the manufacturer must immediately inform the competent national authorities of the EEA states in which the instrument has been made available on the market to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.

Provision of information to the competent authority

13.—(1) A manufacturer must, further to a reasoned request from a competent authority, provide that authority, with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a regulated non-automatic weighing instrument manufactured by that manufacturer with the requirements of these Regulations.

(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.

(3) A manufacturer must co-operate with a competent authority, at the request of that authority, on any action to eliminate the risks posed by regulated non-automatic weighing instruments that the manufacturer has placed on the market.

Use of authorised representatives by manufacturers

14.—(1) A manufacturer may, by written mandate, appoint an authorised representative to discharge the responsibilities of that manufacturer under these Regulations in relation to the placing on the market of a regulated non-automatic weighing instrument.

(2) The authorised representative does not have the power to discharge the manufacturer’s obligations under regulations 6(a) and 6(b).

(3) The authorised representative must be treated as authorised to—

(a) keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authority for 10 years beginning with the day after the day on which a regulated non-automatic weighing instrument has been placed on the market;

(b) provide a competent authority further to a reasoned request from that authority with all the information and documentation necessary to demonstrate the conformity of a regulated non-automatic weighing instrument; and

(c) co-operate with a competent authority, at its request, on any action taken to eliminate the risks posed by regulated non-automatic weighing instruments covered by its mandate.