The Pressure Equipment (Safety) Regulations 2016

Manufacturers U.K.

Design and manufacture in accordance with essential safety requirements U.K.

9.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements.

(2) Before placing pressure equipment or an assembly referred to in regulation 8 on the market or using it for their own purposes, a manufacturer must ensure that it complies with regulation 8(2).

Technical documentation and conformity assessment U.K.

10.—(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must—

(a) classify it using the categories set out in Schedule 3 (classification of pressure equipment), according to an ascending level of hazard;

(b) determine the conformity assessment procedures to apply to the pressure equipment or assembly in accordance with regulation 41 (conformity assessment procedure);

(c) carry out the relevant conformity assessment procedure in respect of that pressure equipment or assembly, or have such a procedure carried out; and

(d) draw up the relevant technical documentation referred to in the conformity assessment module followed in accordance with regulation 41.

(2) For the purposes of paragraph (1)(d), the relevant technical documentation is the following with reference to the modules set out in Annex III to the Directive (as amended from time to time)—

(a) where Module A is followed, the technical documentation is the technical documentation referred to in point 2 under Module A (Internal production control);

(b) where Module A2 is followed, the technical documentation is the technical documentation referred to in point 2 under Module A2 (Internal production control plus supervised pressure equipment checks at random intervals);

(c) where Module B (production type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B (EU-type examination – production type);

(d) where Module B (design type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B (EU-type examination – design type);

(e) where Module G is followed, the technical documentation is the technical documentation referred to in point 2 under Module G (Conformity based on unit verification);

(f) where Module H is followed, the technical documentation is the technical documentation referred to in point 3 under Module H (Conformity based on full quality assurance);

(g) where Module H1 is followed, the technical documentation is the technical documentation referred to in point 3 under Module H1 (Conformity based on full quality assurance plus design examination).

EU declaration of conformity and CE marking U.K.

11.—(1) Where the conformity of pressure equipment or an assembly referred to in regulation 6 or 7 with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the pressure equipment or assembly on the market—

(a) draw up a declaration of conformity in accordance with regulation 48 (EU declaration of conformity);

(b) affix the CE marking in accordance with regulation 49 (CE marking); and

(c) where applicable, ensure that the identification number of the notified body is affixed in accordance with regulation 49.

(2) The requirement in paragraph (1)(b) does not apply in cases where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) The manufacturer must keep the EU declaration of conformity up-to-date.

(4) Where pressure equipment or an assembly is subject to more than one EU instrument requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity which—

(a) identifies the EU instruments; and

(b) includes references to the publication of those EU instruments in the Official Journal.

Duty to keep technical documentation and EU declaration of conformity U.K.

12.  A manufacturer must keep the technical documentation and the EU declaration of conformity drawn up in respect of pressure equipment or an assembly and make them available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the pressure equipment or assembly is placed on the market.

Labelling of pressure equipment and assemblies U.K.

13.—(1) Before placing pressure equipment or an assembly on the market, a manufacturer must—

(a) ensure that it bears a type, batch or serial number or other element allowing its identification; and

(b) ensure that it is marked with—

(i) the name, registered trade name or registered trade mark of the manufacturer; and

(ii) a single postal address at which the manufacturer can be contacted.

(2) Where it is not possible for information specified in paragraph (1)(a) and (b) to be indicated on the pressure equipment or assembly, the manufacturer must ensure that the information is indicated on its packaging or in a document accompanying the pressure equipment or assembly.

(3) The details set out in paragraph (1)(b) must be in a language which can be easily understood by consumers, other users and market surveillance authorities in the member State in which it is to be made available to such users.

Instructions and safety information U.K.

14.—(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users.

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, a manufacturer must ensure that it is accompanied by adequate instructions for use in a language which can be easily understood by consumers and other users.

(4) Where the pressure equipment or assembly is placed on the market in the United Kingdom, the language referred to in paragraphs (1) and (3) must be English.

(5) Instructions and safety information must be clear, understandable and intelligible.

Compliance procedures for series production U.K.

15.—(1) A manufacturer of pressure equipment or assemblies which are manufactured by series production must ensure that procedures are in place to ensure that any pressure equipment or assemblies so manufactured will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a) any change in pressure equipment or assembly design or characteristics; and

(b) any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity was drawn up.

Monitoring U.K.

16.—(1) When appropriate, with regard to the risks to the health and safety of consumers and other users presented by pressure equipment or assemblies, the manufacturer must—

(a) carry out sample testing of pressure equipment or assemblies made available on the market;

(b) investigate complaints that pressure equipment or assemblies are not in conformity with Part 2;

(c) keep a register of—

(i) complaints that pressure equipment or assemblies are not in conformity with Part 2;

(ii) pressure equipment or assemblies which are found not to be in conformity with Part 2; and

(iii) pressure equipment or assemblies recalls; and

(d) keep distributors informed of any monitoring carried out under this regulation.

(2) The manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Duty to take action in respect of pressure equipment or assemblies placed on the market which are considered not to be in conformity U.K.

17.—(1) A manufacturer who considers, or has reason to believe, that pressure equipment or an assembly which that manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.

(2) Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authority, and the competent national authorities of any other member State in which the manufacturer made the pressure equipment or assembly available on the market, of the risk, giving details of—

(a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Provision of information and cooperation U.K.

18.—(1) Further to a request from an enforcing authority, and within such period as the authority may specify, a manufacturer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a) may only be made during the period of 10 years beginning on the day the pressure equipment or assembly was placed on the market; and

(b) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a) may be provided electronically; and

(b) must be in a language which can be easily understood by the enforcing authority.

(4) A manufacturer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a) evaluate pressure equipment or an assembly in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b) eliminate the risks posed by pressure equipment or an assembly which the manufacturer has placed on the market.

Manufacturer's authorised representatives U.K.

19.—(1) A manufacturer may, by written mandate, appoint a person as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to pressure equipment or assemblies covered by the mandate—

(a) perform the manufacturer's obligations under regulation 12 (duty to keep technical documentation and EU declaration of conformity); and

(b) perform the manufacturer's obligations under regulation 18 (provision of information and cooperation).

(3) The obligations laid down in regulation 9 (design and manufacture in accordance with the essential safety requirements) and regulation 10(1)(b) (technical documentation and conformity assessment) must not form part of an authorised representative's mandate.

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the manufacturer to perform and, accordingly as far as those duties, as well as the penalties for failure to comply with those duties, are concerned, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer's behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.