The Measuring Instruments Regulations 2016

CHAPTER 2 OBLIGATIONS OF IMPORTERS

Introductory

16.  This Chapter applies to the placing on the market or the putting into use of a regulated measuring instrument from a country outside the European Economic Area that is imported into the United Kingdom.

Ensuring compliance of regulated measuring instruments

17.—(1) An importer must only place compliant regulated measuring instruments on the market.

(2) An importer must ensure that—

(a) the appropriate conformity assessment procedure has been carried out by the manufacturer of the regulated measuring instrument (or by the importer where the importer is to be regarded as the manufacturer by virtue of regulation 6(2));

(b) the manufacturer has drawn up the technical documentation (or that the importer has done so where the importer is treated as the manufacturer by virtue of regulation 6(2));

(c) the regulated measuring instrument bears the CE marking and the M marking;

(d) the regulated measuring instrument is accompanied by a copy of the EU declaration of conformity and the documents referred to in regulation 12 (documentation to accompany regulated measuring instruments); and

(e) the manufacturer (or the importer where he is treated as the manufacturer) has complied with the requirements of regulations 10 (manufacturers’ obligations in relation to the marking of regulated measuring instruments with serial numbers etc.) and 11 (manufacturers to mark contact details on regulated measuring instruments where possible).

Importers duty to notify manufacturer and market surveillance authorities of non-compliant regulated measuring instruments that present a risk

18.  Where an importer considers or has reason to believe that the regulated measuring instrument is not in conformity with the essential requirements and presents a risk, the importer must inform the manufacturer and the market surveillance authority.

Requirements to mark importers’ details on regulated measuring instruments

19.—(1) An importer must indicate on regulated measuring instruments imported by that importer, the importer’s name, registered trade name or trademark and the postal address at which the importer can be contacted.

(2) Where a regulated measuring instrument is too small or of too sensitive a composition to allow it to bear the information required by paragraph (1), such information must be marked on any packaging in which the instrument is supplied and on any accompanying documents.

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

Importers’ duty to ensure that regulated measuring instruments are accompanied by relevant documentation

20.—(1) An importer must ensure that regulated measuring instruments imported by that importer are, where relevant, accompanied by the following instructions and information in a language easily understood by end-users—

(a) rated operating conditions;

(b) mechanical and electromagnetic environment classes;

(c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

(d) instructions for installation maintenance, repairs, permissible adjustments;

(e) instructions for correct operation and any special conditions of use; and

(f) conditions for compatibility with interfaces, sub-assemblies or measuring instruments.

(2) Where the end users are in the United Kingdom, the instructions and information referred to in paragraph (1) must be in English.

Duty of importers to ensure proper conditions of storage and transport

21.  An importer must, in respect of regulated measuring instruments under the importer’s responsibility ensure that the conditions of their storage or transport are not such as to jeopardise their continuing compliance with the essential requirements.

Duties of importers with regard to monitoring etc.

22.—(1) When deemed appropriate with regard to the performance of a regulated measuring instrument imported by an importer, the importer must—

(a) carry out a sample testing of regulated measuring instruments made available on the market by the importer;

(b) investigate complaints about regulated measuring instruments imported by the importer ; and

(c) if necessary, keep a register of—

(i) such complaints;

(ii) non-conforming regulated measuring instruments; and

(iii) regulated measuring instrument recalls; and

(d) where the importer is not also the distributor of the regulated measuring instrument, keep distributors to whom the importer has supplied regulated measuring instruments informed of any monitoring undertaken by that importer.

Action to be taken by importers where regulated measuring instruments placed on the market by them are not in conformity with essential requirements

23.—(1) This regulation applies where an importer considers, or has reason to believe, that a regulated measuring instrument placed on the market by the importer is not in conformity with the requirements of these Regulations.

(2) The importer must immediately take the corrective measures necessary to bring the regulated measuring instrument into conformity or withdraw or recall it, if appropriate.

(3) Where the regulated measuring instrument presents a risk, the importer must immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that importer.

Requirement for importer to keep copy of EU declaration of conformity

24.  An importer must, for a period of 10 years beginning with the day after the day on which the regulated measuring instrument is placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request.

Provision of information to the competent authority

25.—(1) The importer must, further to a reasoned request from a competent authority, provide the competent authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the regulated measuring instrument 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) An importer must co-operate with a competent authority, at its request, as regards any action to eliminate the risks posed by any regulated measuring instrument that the importer has placed on the market.