# Directive 2014/68/EU of the European Parliament and of the CouncilShow full title

Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the            Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance)         

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# Directive 2014/68/EU of the European Parliament and of the Council

# of 15 May 2014

# on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment

# (recast)

# (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(1),                        

Acting in accordance with the ordinary legislative procedure(2),                        

Whereas:

(1)Directive 97/23/EC of the European Parliament and of the Council(3) has been substantially amended(4). Since further amendments are to be made, that Directive should be recast in the interests of clarity.

(2)Regulation (EC) No 765/2008 of the European Parliament and of the Council(5) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of                              products and for controls on products from third countries, and lays down the general principles of the CE marking.

(3)Decision No 768/2008/EC of the European Parliament and of the Council(6) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a                              coherent basis for revision or recasts of that legislation. Directive 97/23/EC should therefore be adapted to that Decision.

(4)This Directive covers pressure equipment and assemblies which are new to the Union market when they are placed on the market;                              that is to say they are either new pressure equipment or assemblies made by a manufacturer established in the Union or pressure                              equipment or assemblies, whether new or second-hand, imported from a third country.

(5)This Directive should apply to all forms of supply, including distance selling.

(6)This Directive should apply to pressure equipment subject to a maximum allowable pressure PS greater than 0,5 bar. Pressure                              equipment subject to a pressure of not more than 0,5 bar does not pose a significant risk due to pressure. Therefore, there                              should not be any obstacle to its free movement within the Union.

(7)This Directive should also apply to assemblies composed of several pieces of pressure equipment assembled to constitute an                              integrated and functional whole. Those assemblies may range from simple assemblies such as pressure cookers to complex assemblies                              such as water tube boilers. If the manufacturer of an assembly intends to place it on the market and put it into service as                              an assembly — and not in the form of its constituent non-assembled elements — that assembly should comply with this Directive.                              However, this Directive should not apply to the assembly of pressure equipment on the site and under the responsibility of                              a user who is not the manufacturer, as in the case of industrial installations.

(8)This Directive should harmonise national provisions on risks due to pressure. The other risks which this equipment may present                              may fall within the scope of other Directives dealing with those risks.

(9)However, some pressure equipment is covered by other Directives based on Article 114 of the Treaty on the Functioning of the                              European Union (TFEU). The provisions laid down in some of those Directives deal also with the risk due to pressure. Those                              Directives are considered adequate to provide appropriate protection where the risk due to pressure associated with such equipment                              remains small. Therefore, such equipment should be excluded from the scope of this Directive.

(10)For some pressure equipment covered by international agreements for its international transport, national transport and pressure                              hazards and risks are dealt with by Union Directives based on such agreements. Those Directives extend the application of                              those agreements to national transport, in order to ensure the free movement of dangerous goods whilst enhancing transport                              safety. Such equipment which is covered by Directive 2008/68/EC of the European Parliament and of the Council(7) and by Directive 2010/35/EU of the European Parliament and of the Council(8) should be excluded from the scope of this Directive.

(11)Certain types of pressure equipment, although subject to a maximum allowable pressure PS greater than 0,5 bar, do not present                              any significant risk due to pressure, and therefore the free movement of such equipment in the Union should not be hindered                              if it has been legally manufactured or placed on the market in a Member State. It is not necessary in order to ensure free                              movement of such equipment to include it within the scope of this Directive. Consequently it should be expressly excluded                              from its scope.

(12)Other pressure equipment subject to a maximum allowable pressure greater than 0,5 bar and presenting a significant risk due                              to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, should be excluded from                              the scope of this Directive. Such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary                              to take action at Union level.

(13)The scope of this Directive should be based on a general definition of the term ‘pressure equipment’ so as to allow for the                              technical development of products.

(14)Compliance with the essential safety requirements is necessary in order to ensure the safety of pressure equipment. Those                              requirements should be subdivided into general and specific requirements that need to be met by pressure equipment. In particular                              the specific requirements should take account of particular types of pressure equipment. Certain types of pressure equipment                              in categories III and IV should be subject to a final assessment comprising final inspection and proof tests.

(15)Member States should be in a position to allow the showing at trade fairs of pressure equipment which is not yet in conformity                              with the requirements of this Directive. During demonstrations, appropriate safety measures should be taken in accordance                              with the general safety rules of the Member State concerned to ensure the safety of persons.

(16)Directive 97/23/EC provides for a classification of pressure equipment in categories, according to the ascending level of                              hazard. This includes the classification of the fluid contained in the pressure equipment as dangerous or not, according to                              Council Directive 67/548/EEC(9). On 1 June 2015 Directive 67/548/EEC is to be repealed and replaced by Regulation (EC) No 1272/2008 of the European Parliament                              and of the Council(10), which implements in the Union the Globally Harmonised System of Classification and Labelling of Chemicals that has been                              adopted at international level, within the United Nations structure. Regulation (EC) No 1272/2008 introduces new hazard classes                              and categories only partially corresponding to those provided for by Directive 67/548/EEC. Directive 97/23/EC should therefore                              be aligned to Regulation (EC) No 1272/2008 while maintaining the existing levels of protection provided for in that Directive.

(17)Economic operators should be responsible for the compliance of pressure equipment and assemblies with the requirements of                              this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public                              interests, such as health and safety of persons, and the protection of domestic animals and of property, and to guarantee                              fair competition on the Union market.

(18)All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they                              only make available on the market pressure equipment and assemblies which are in conformity with this Directive. It is necessary                              to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator                              in the supply and distribution chain.

(19)The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity                              assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.

(20)In order to facilitate the communication between economic operators, market surveillance authorities and consumers, Member                              States should encourage economic operators to include a website address in addition to the postal address.

(21)It is necessary to ensure that pressure equipment and assemblies from third countries entering the Union market comply with                              the requirements of this Directive, and in particular that appropriate conformity assessment procedures have been carried                              out by manufacturers with regard to that pressure equipment or those assemblies. Provision should therefore be made for importers                              to make sure that the pressure equipment or assembly they place on the market complies with the requirements of this Directive                              and that they do not place on the market pressure equipment or assemblies which do not comply with such requirements or presents                              a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried                              out and that marking of pressure equipment or assemblies and documentation drawn up by manufacturers are available for inspection                              by the competent national authorities.

(22)When placing pressure equipment or assemblies on the market, every importer should indicate on the pressure equipment or assembly                              his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should                              be provided for in cases where the size or nature of the pressure equipment or assembly does not allow it. This includes cases                              where the importer would have to open the packaging to put his name and address on the pressure equipment or assembly.

(23)The distributor makes pressure equipment or assemblies available on the market after they have been placed on the market by                              the manufacturer or the importer and should act with due care to ensure that its handling of the pressure equipment or assembly                              does not adversely affect the compliance of the pressure equipment or assembly with the requirements of this Directive.

(24)Any economic operator that either places pressure equipment or assemblies on the market under his own name or trademark or                              modifies pressure equipment or assemblies in such a way that compliance with the requirements of this Directive may be affected                              should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(25)Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by                              the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary                              information relating to the pressure equipment or assembly concerned.

(26)Ensuring traceability of pressure equipment and assemblies throughout the whole supply chain helps to make market surveillance                              simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing                              economic operators who made non-compliant pressure equipment or assemblies available on the market.

(27)When keeping the information required under this Directive for the identification of other economic operators, economic operators                              should not be required to update such information in respect of other economic operators who have either supplied them with                              pressure equipment or an assembly or to whom they have supplied pressure equipment or an assembly.

(28)This Directive should be limited to the expression of the essential safety requirements. In order to facilitate conformity                              assessment with those requirements it is necessary to provide for a presumption of conformity for pressure equipment or assemblies                              which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the                              European Parliament and of the Council(11) for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design,                              manufacture and testing of pressure equipment or assemblies.

(29)Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not                              entirely satisfy the requirements of this Directive.

(30)Manufacturing of pressure equipment calls for the utilisation of safe materials. In the absence of harmonised standards the                              characteristics of the materials intended for repeated use should be established. Those characteristics should be established                              by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for                              that task. The materials conforming to the European approvals should benefit from a presumption of conformity with the essential                              safety requirements of this Directive.

(31)In view of the nature of the risks involved in the use of pressure equipment and assemblies and in order to enable economic                              operators to demonstrate and the competent authorities to ensure that pressure equipment or assemblies made available on the                              market comply with the essential safety requirements, it is necessary to provide for conformity assessment procedures. Those                              procedures should be devised in the light of the level of hazard which is inherent in the pressure equipment or assembly.                              Therefore, for each category of pressure equipment there should be an adequate procedure or a choice between different procedures                              of equivalent stringency. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include                              procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required.                              In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen                              from among those modules. The details added to those procedures are justified by the nature of the verification required for                              pressure equipment.

(32)Member States should be in a position to authorise user inspectorates to carry out certain tasks for conformity assessment                              in the framework of this Directive. For that purpose this Directive should set out criteria for the authorisation of user                              inspectorates by Member States.

(33)Under certain procedures for conformity assessment it should be possible for each item to be inspected and tested by a notified                              body or a user inspectorate as part of the final assessment of the pressure equipment or assembly. In other cases provision                              should be made to ensure that the final assessment may be monitored by a notified body by means of unexpected visits.

(34)Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity                              of the pressure equipment or assembly with the requirements of this Directive and of other relevant Union harmonisation legislation.

(35)To ensure effective access to information for market surveillance purposes, in cases where pressure equipment or an assembly                              is covered by several pieces of Union harmonisation legislation, the information required to identify all applicable Union                              acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic                              operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

(36)A check on compliance with the essential safety requirements is necessary in order to provide effective protection for consumers,                              other users and third parties.

(37)Pressure equipment and assemblies should, as a general rule, bear the CE marking. The CE marking, indicating the conformity                              of pressure equipment or assemblies, is the visible consequence of a whole process comprising conformity assessment in a broad                              sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008.                              Rules governing the affixing of the CE marking should be laid down in this Directive.

(38)For pressure equipment defined in this Directive which presents only a minor pressure risk and for which certification procedures                              are therefore not justified, the CE marking should not be affixed.

(39)Certain conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies,                              which are notified by the Member States to the Commission.

(40)Experience has shown that the criteria set out in Directive 97/23/EC that conformity assessment bodies have to fulfil to be                              notified to the Commission are not sufficient to ensure a uniformly high level of performance of those bodies throughout the                              Union. It is, however, essential that all conformity assessment bodies perform their functions to the same level and under                              conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing                              to be notified in order to provide conformity assessment services.

(41)If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be                              presumed to comply with the corresponding requirements set out in this Directive.

(42)In order to ensure a consistent level of conformity assessment quality, it is also necessary to set requirements for notifying                              authorities and other bodies involved in the assessment, notification and monitoring of conformity assessment bodies.

(43)The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008.                              Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used                              for the purposes of notification.

(44)Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates                              of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating                              the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the                              appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility                              of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with                              the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant                              regulatory requirements.

(45)Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have                              recourse to a subsidiary. In order to safeguard the level of protection required for the pressure equipment or assembly to                              be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same                              requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important                              that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified                              cover also activities carried out by subcontractors and subsidiaries.

(46)It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it                              to new technologies so as to enable online notification.

(47)Since conformity assessment bodies may offer their services throughout the Union, it is appropriate to give the other Member                              States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide                              for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before                              they start operating as notified bodies.

(48)In the interests of competitiveness, it is crucial that conformity assessment bodies apply the conformity assessment procedures                              without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic                              operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can                              best be achieved through appropriate coordination and cooperation between conformity assessment bodies.

(49)Member States should take all appropriate measures to ensure that pressure equipment and assemblies may be placed on the market                              only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen,                              they do not endanger the health and safety of persons. Pressure equipment or assemblies should be considered as non-compliant                              with the essential safety requirements laid down in this Directive only under conditions of use which can be reasonably foreseen,                              that is when such use could result from lawful and readily predictable human behaviour.

(50)In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred to                              the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament                              and of the Council(12).

(51)The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take                              the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their                              notification.

(52)The examination procedure should be used for the adoption of implementing acts with respect to European approvals for materials                              presenting shortcomings and whose references were already published in the *Official Journal of the European Union*, given that such decisions could have consequences on the presumption of conformity with the applicable essential requirements.

(53)The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant                              pressure equipment or assemblies which present a risk to the health or safety of persons, to domestic animals or to property,                              imperative grounds of urgency so require.

(54)In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning                              the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its                              rules of procedure.

(55)When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission                              expert group, the European Parliament should in line with existing practice receive full information and documentation and,                              where appropriate, an invitation to attend such meetings.

(56)The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation                              (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant pressure equipment or assemblies                              are justified or not.

(57)In order to take into account emerging very serious safety reasons, the power to adopt acts in accordance with Article 290                              TFEU should be delegated to the Commission in respect of amendments to classification of pressure equipment or assemblies.                              The reclassification should be based on appropriate evidence and justification in each case. It is of particular importance                              that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(58)The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission                              of relevant documents to the European Parliament and to the Council.

(59)Directive 97/23/EC provides for a transitional arrangement enabling pressure equipment and assemblies which comply with the                              national regulations in force on the date of application of Directive 97/23/EC to be put into service. For reasons of legal                              certainty, it is necessary to include that transitional arrangement also in this Directive.

(60)It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and the                              putting into service, without the need to comply with further product requirements, of pressure equipment and assemblies that                              have already been placed on the market in accordance with Directive 97/23/EC before the date of application of national measures                              transposing this Directive. Distributors should therefore be able to supply pressure equipment and assemblies that have been                              placed on the market, namely stock that is already in the distribution chain, before the date of application of national measures                              transposing this Directive.

(61)Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant                              to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate                              and dissuasive.

(62)Since the objective of this Directive, namely to ensure that pressure equipment or assemblies on the market fulfil the requirements                              providing a high level of protection of health and safety of persons and protection of domestic animals or property while                              guaranteeing the functioning of the internal market cannot be sufficiently achieved by the Member States but can rather, by                              reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle                              of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality,                              as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(63)The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive                              amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under                              the earlier Directive.

(64)This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for transposition                              into national law and the date of application of the Directive set out in Annex V, Part B,

HAVE ADOPTED THIS DIRECTIVE:

## CHAPTER 1U.K.**GENERAL PROVISIONS**

### Article 1U.K.Scope

1.This Directive shall apply to the design, manufacture and conformity assessment of pressure equipment and assemblies with                        a maximum allowable pressure PS greater than 0,5 bar.                  

2.This Directive shall not apply to:                  

(a)pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation                        (onshore or offshore) starting from and including the last isolation device located within the confines of the installation,                        including all the annexed equipment designed specifically for pipelines; this exclusion shall not apply to standard pressure                        equipment such as may be found in pressure reduction stations or compression stations;                  

(b)networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure                        tunnels, pressure shafts for hydroelectric installations and their related specific accessories;                  

(c)simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council(13);                  

(d)aerosol dispensers covered by Council Directive 75/324/EEC(14);                  

(e)equipment intended for the functioning of vehicles defined by the following legal acts:                  

Directive 2007/46/EC of the European Parliament and of the Council(15);                           

Regulation (EU) No 167/2013 of the European Parliament and of the Council(16);                           

Regulation (EU) No 168/2013 of the European Parliament and of the Council(17);                           

(f)equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the following Directives:                  

Directive 2006/42/EC of the European Parliament and of the Council(18);                           

Directive 2014/33/EU of the European Parliament and of the Council(19);                           

Directive 2014/35/EU of the European Parliament and of the Council(20);                           

Council Directive 93/42/EEC(21);                           

Directive 2009/142/EC of the European Parliament and of the Council(22);                           

Directive 2014/34/EU of the European Parliament and of the Council(23);                           

(g)equipment covered by point (b) of Article 346(1) TFEU;                  

(h)items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;                  

(i)well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage                        which is intended to contain and/or control well pressure; this shall comprise the wellhead (Christmas tree), the blow out                        preventers (BOP), the piping manifolds and all their equipment upstream;                  

(j)equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily                        on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other                        operational characteristics and for which pressure is not a significant design factor; such equipment may include:                  

engines including turbines and internal combustion engines;

steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;

(k)blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas                        scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing                        and casting of steel, iron and non-ferrous metals;                  

(l)enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;                  

(m)pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;                  

(n)ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board                        or the propulsion thereof;                  

(o)pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other                        similar pressure equipment;                  

(p)exhaust and inlet silencers;                  

(q)bottles or cans for carbonated drinks for final consumption;                  

(r)vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable                        pressure not exceeding 7 bar;                  

(s)equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International Maritime Dangerous                        Goods Code and the Convention on International Civil Aviation;                  

(t)radiators and pipes in warm water heating systems;                  

(u)vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.                  

### Article 2U.K.Definitions

For the purposes of this Directive, the following definitions shall apply:

‘pressure equipment’ means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements                              attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs;                           

‘vessel’ means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling                              point connecting it to other equipment; a vessel may be composed of more than one chamber;                           

‘piping’ means piping components intended for the transport of fluids, when connected together for integration into a pressure                              system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing                              components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered                              as piping;                           

‘safety accessories’ means devices designed to protect pressure equipment against the allowable limits being exceeded, including                              devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety                              pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown                              or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement                              control and regulation (SRMCR) devices;                           

‘pressure accessories’ means devices with an operational function and having pressure-bearing housings;

‘assemblies’ means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional                              whole;                           

‘pressure’ means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by                              a negative value;                           

‘maximum allowable pressure PS’ means the maximum pressure for which the equipment is designed, as specified by the manufacturer,                              and defined at a location specified by him, being either the connection of protective and/or limiting devices, or the top                              of equipment or, if not appropriate, any point specified;                           

‘maximum/minimum allowable temperature TS’ means the maximum/minimum temperatures for which the equipment is designed, as                              specified by the manufacturer;                           

‘volume (V)’ means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding                              the volume of permanent internal parts;                           

‘nominal size (DN)’ means a numerical designation of size which is common to all components in a piping system other than                              components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is                              only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number;                           

‘fluids’ means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension of solids;

‘permanent joints’ means joints which cannot be disconnected except by destructive methods;

‘European approval for materials’ means a technical document defining the characteristics of materials intended for repeated                              use in the manufacture of pressure equipment which are not covered by any harmonised standard;                           

‘making available on the market’ means any supply of pressure equipment or assemblies for distribution or use on the Union                              market in the course of a commercial activity, whether in return for payment or free of charge;                           

‘placing on the market’ means the first making available of pressure equipment or assemblies on the Union market;

‘putting into service’ means the first use of pressure equipment or an assembly by its user;

‘manufacturer’ means any natural or legal person who manufactures pressure equipment or an assembly or has such equipment                              or assembly designed or manufactured, and markets that pressure equipment or assembly under his name or trademark or uses                              it for his own purposes;                           

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate                              from a manufacturer to act on his behalf in relation to specified tasks;                           

‘importer’ means any natural or legal person established within the Union who places pressure equipment or assemblies from                              a third country on the Union market;                           

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes                              pressure equipment or assemblies available on the market;                           

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by pressure equipment or                              assemblies;                           

‘harmonised standard’ means harmonised standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012;

‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

‘conformity assessment’ means the process demonstrating whether the essential safety requirements of this Directive relating                              to pressure equipment or assemblies have been fulfilled;                           

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification                              and inspection;                           

‘recall’ means any measure aimed at achieving the return of pressure equipment or assemblies that have already been made available                              to consumers or other users;                           

‘withdrawal’ means any measure aimed at preventing pressure equipment or assemblies in the supply chain from being made available                              on the market;                           

‘CE marking’ means a marking by which the manufacturer indicates that the pressure equipment or assembly is in conformity                              with the applicable requirements set out in Union harmonisation legislation providing for its affixing;                           

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products.

### Article 3U.K.Making available on the market and putting into service

1.Member States shall take all appropriate measures to ensure that pressure equipment and assemblies may be made available on                        the market and put into service only if they satisfy the requirements of this Directive when properly installed and maintained                        and used for the purposes for which they are intended.                  

2.This Directive shall not affect Member States’ entitlement to lay down such requirements as they may deem necessary to ensure                        that persons and, in particular, workers are protected during use of the pressure equipment or assembly in question provided                        that this does not mean modifications to such equipment or assembly in a way not specified in this Directive.                  

3.At trade fairs, exhibitions, demonstrations and other similar events, Member States shall not prevent the showing of pressure                        equipment or assemblies which do not comply with this Directive, provided that a visible sign clearly indicates that such                        pressure equipment or assemblies may not be made available on the market and/or put into service until they are brought into                        conformity. During demonstrations, appropriate safety measures shall be taken in accordance with any requirements laid down                        by the competent authority of the Member State concerned in order to ensure the safety of persons.                  

### Article 4U.K.Technical requirements

1.The following pressure equipment shall satisfy the essential safety requirements set out in Annex I:                  

(a)vessels, except those referred to in point (b), for:                  

gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum                              allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:                           
                -  for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar·L, or with a pressure PS                                    greater than 200 bar (Annex II, table 1),                                  
                -  for fluids in Group 2, with a volume greater than 1 L and a product of PS and V is greater than 50 bar·L, or with a pressure                                    PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus (Annex II, table 2);                                  

liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure                              (1 013 mbar) within the following limits:                           
                -  for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar·L, or with a pressure                                    PS greater than 500 bar (Annex II, table 3),                                  
                -  for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10 000 bar·L, or with                                    a pressure PS greater than 1 000 bar (Annex II, table 4);                                  

(b)fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated                        water at temperatures higher than 110 °C having a volume greater than 2 L, and all pressure cookers (Annex II, table 5);                  

(c)piping intended for:                  

gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable                              temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within the following limits:                           
                -  for fluids in Group 1 with a DN greater than 25 (Annex II, table 6), 
                -  for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1 000 bar (Annex II, table 7); 

liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure                              (1 013 mbar) within the following limits:                           
                -  for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2 000 bar (Annex II, table 8), 
                -  for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5 000 bar                                    (Annex II, table 9).                                  

(d)safety and pressure accessories intended for equipment covered by points (a), (b), and (c) including where such equipment                        is incorporated into an assembly.                  

2.The following assemblies which include at least one item of pressure equipment covered by paragraph 1 shall satisfy the essential                        safety requirements set out in Annex I:                  

(a)assemblies intended for generating steam or superheated water at a temperature higher than 110 °C comprising at least one                        item of fired or otherwise heated pressure equipment presenting a risk of overheating;                  

(b)assemblies other than those referred to in point (a), if the manufacturer intends them to be made available on the market                        and put into service as assemblies.                  

By way of derogation from the first subparagraph, assemblies intended for generating warm water at temperatures not greater                     than 110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L shall comply with the essential                     safety requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.                  

3.Pressure equipment and assemblies below or equal to the limits set out in points (a), (b) and (c) of paragraph 1 and in paragraph                        2 respectively shall be designed and manufactured in accordance with the sound engineering practice of a Member State in order                        to ensure safe use. Pressure equipment and assemblies shall be accompanied by adequate instructions for use.                  

Without prejudice to other applicable Union harmonisation legislation providing for its affixing, such equipment or assemblies                     shall not bear the CE marking referred to in Article 18.                  

### Article 5U.K.Free movement

1.Member States shall not, on grounds of the risks due to pressure, prohibit, restrict or impede the making available on the                        market or the putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies                        which comply with this Directive.                  

Member States shall not, on grounds of the risks due to pressure, prohibit, restrict or impede the making available on the                     market or the putting into service of pressure equipment or assemblies which comply with Article 4(3).                  

2.When a Member State has designated a user inspectorate in accordance with the requirements set out in Article 25, it may not,                        on grounds of the risks due to pressure, prohibit, restrict or impede the placing on the market or putting into service under                        the conditions provided for in Article 16, of pressure equipment or assemblies the conformity of which has been assessed by                        a user inspectorate designated by another Member State in accordance with the requirements set out in Article 25.                  

3.Member States may require, to the extent that it is needed for safe and correct use of pressure equipment and assemblies,                        the information referred to in points 3.3 and 3.4 of Annex I to be provided in the official language(s) of the Union which                        may be determined by the Member State in which the equipment or assembly is made available on the market.                  

## CHAPTER 2U.K.**OBLIGATIONS OF ECONOMIC OPERATORS**

### Article 6U.K.Obligations of manufacturers

1.When placing their pressure equipment or assemblies referred to in Article 4(1) and (2) on the market or using them for their                        own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety                        requirements set out in Annex I.                  

When placing their pressure equipment or assemblies referred to in Article 4(3) on the market or using them for their own                     purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the sound engineering                     practice of a Member State.                  

2.For the pressure equipment or assemblies referred to in Article 4(1) and (2), manufacturers shall draw up the technical documentation                        referred to in Annex III and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried                        out.                  

Where compliance of the pressure equipment or assemblies referred to in Article 4(1) and (2) with the applicable requirements                     has been demonstrated by the procedure referred to in the first subparagraph of this paragraph, manufacturers shall draw up                     an EU declaration of conformity and affix the CE marking.                  

3.Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after pressure equipment                        or assemblies have been placed on the market.                  

4.Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive.                        Changes in design or characteristics of pressure equipment or assemblies and changes in the harmonised standards or in other                        technical specifications by reference to which conformity of pressure equipment or assemblies is declared shall be adequately                        taken into account.                  

When deemed appropriate with regard to the risks presented by pressure equipment or assemblies, manufacturers shall, to protect                     the health and safety of consumers and other users, carry out sample testing of pressure equipment or assemblies made available                     on the market, investigate, and, if necessary, keep a register of complaints of non-conforming pressure equipment and assemblies                     and recalls of such equipment, and shall keep distributors informed of any such monitoring.                  

5.Manufacturers shall ensure that their pressure equipment or assemblies bear a type, batch or serial number or other element                        allowing their identification, or, where the size or nature of the equipment or assembly does not allow it, that the required                        information is provided on the packaging or in a document accompanying the equipment.                  

6.Manufacturers shall indicate on the pressure equipment or assembly their name, registered trade name or registered trade mark                        and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying                        the equipment or assembly. The address shall indicate a single point at which the manufacturer can be contacted. The contact                        details shall be in a language easily understood by consumers, other users and market surveillance authorities.                  

7.Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4(1) and (2) is accompanied by                        instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can be easily understood                        by consumers and other users, as determined by the Member State concerned. Such instructions and safety information shall                        be clear, understandable and intelligible.                  

Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4(3) are accompanied by instructions                     and safety information in accordance with Article 4(3), in a language which can be easily understood by consumers and other                     users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable                     and intelligible.                  

8.Manufacturers who consider or have reason to believe that pressure equipment or assemblies which they have placed on the market                        are not in conformity with this Directive shall immediately take the corrective measures necessary to bring that pressure                        equipment or those assemblies into conformity, to withdraw it or recall it, if appropriate. Furthermore, where pressure equipment                        or assemblies present a risk, manufacturers shall immediately inform the competent national authorities of the Member States                        in which they made that pressure equipment or those assemblies available on the market to that effect, giving details, in                        particular, of the non-compliance and of any corrective measures taken.                  

9.Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information                        and documentation necessary to demonstrate the conformity of the pressure equipment or assembly with this Directive, in a                        language which can be easily understood by that authority. That information and documentation may be provided in paper or                        electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed                        by the pressure equipment or assembly which they have placed on the market.                  

### Article 7U.K.Authorised representatives

1.A manufacturer may, by a written mandate, appoint an authorised representative.                  

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2)                     shall not form part of the authorised representative’s mandate.                  

2.An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate                        shall allow the authorised representative to do at least the following:                  

(a)keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities                        for 10 years after the pressure equipment or assembly has been placed on the market;                  

(b)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation                        necessary to demonstrate the conformity of the pressure equipment or assembly;                  

(c)cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the                        pressure equipment or assembly covered by the authorised representative’s mandate.                  

### Article 8U.K.Obligations of importers

1.Importers shall place only compliant pressure equipment or assemblies on the market.                  

2.Before placing on the market the pressure equipment or assemblies referred to in Article 4(1) and (2), importers shall ensure                        that the appropriate conformity assessment procedure in accordance with Article 14 has been carried out by the manufacturer.                        They shall ensure that the manufacturer has drawn up the technical documentation, that pressure equipment or assemblies bear                        the CE marking and are accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I,                        and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).                  

Before placing on the market the pressure equipment or assemblies referred to in Article 4(3), importers shall ensure that                     the manufacturer has drawn up the technical documentation and that pressure equipment or assemblies are accompanied by adequate                     instructions for use and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).                  

Where an importer considers or has reason to believe that the pressure equipment or assembly is not in conformity with the                     essential safety requirements set out in Annex I, he shall not place the pressure equipment or assembly on the market until                     it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a risk, the importer shall                     inform the manufacturer and the market surveillance authorities to that effect.                  

3.Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can                        be contacted on the pressure equipment or assembly, or, where that is not possible, on its packaging or in a document accompanying                        the equipment or assembly. The contact details shall be in a language easily understood by consumers, other users and market                        surveillance authorities.                  

4.Importers shall ensure that pressure equipment or assemblies referred to in Article 4(1) and (2) are accompanied by instructions                        and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can be easily understood by consumers                        and other users, as determined by the Member State concerned.                  

Importers shall ensure that the pressure equipment or assembly referred to in Article 4(3) is accompanied by instructions                     and safety information in a language which can be easily understood by consumers and other users, as determined by the Member                     State concerned.                  

5.Importers shall ensure that, while pressure equipment or assemblies referred to in Article 4(1) and (2) are under their responsibility,                        storage or transport conditions do not jeopardise their compliance with the essential safety requirements set out in Annex                        I.                  

6.When deemed appropriate with regard to the risks presented by pressure equipment or assemblies, importers shall, to protect                        the health and safety of consumers and other users, carry out sample testing of pressure equipment and assemblies made available                        on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming pressure equipment or assemblies                        and recalls of such equipment, and shall keep distributors informed of any such monitoring.                  

7.Importers who consider or have reason to believe that pressure equipment or assemblies which they have placed on the market                        are not in conformity with this Directive shall immediately take the corrective measures necessary to bring that pressure                        equipment or assembly into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the pressure equipment                        or assembly presents a risk, importers shall immediately inform the competent national authorities of the Member States in                        which they made the pressure equipment or assembly available on the market to that effect, giving details, in particular,                        of the non-compliance and of any corrective measures taken.                  

8.Importers shall, for 10 years after the pressure equipment or assembly has been 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.                  

9.Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and                        documentation necessary to demonstrate the conformity of pressure equipment or an assembly in a language which can be easily                        understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate                        with that authority, at its request, on any action taken to eliminate the risks posed by pressure equipment or an assembly                        which they have placed on the market.                  

### Article 9U.K.Obligations of distributors

1.When making pressure equipment or assemblies available on the market distributors shall act with due care in relation to the                        requirements of this Directive.                  

2.Before making the pressure equipment or assemblies referred to in Article 4(1) and (2) available on the market distributors                        shall verify that the pressure equipment or assembly bears the CE marking, that it is accompanied by the required documents                        and by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can be easily                        understood by consumers and other users in the Member State in which the pressure equipment or assembly is to be made available                        on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and                        (6) and Article 8(3) respectively.                  

Where a distributor considers or has reason to believe that pressure equipment or assemblies are not in conformity with the                     essential safety requirements set out in Annex I, he shall not make the pressure equipment or assembly available on the market                     until it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a risk, the distributor                     shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.                  

Before making the pressure equipment or assembly referred to in Article 4(3) available on the market, distributors shall verify                     that that pressure equipment or assembly is accompanied by adequate instructions for use, in a language which can be easily                     understood by consumers and other users in the Member State in which that pressure equipment or assembly is to be made available                     on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and                     (6) and Article 8(3) respectively.                  

3.Distributors shall ensure that, while the pressure equipment or assemblies referred to in Article 4(1) and (2) are under their                        responsibility, storage or transport conditions do not jeopardise their compliance with the essential safety requirements                        set out in Annex I.                  

4.Distributors who consider or have reason to believe that pressure equipment or assemblies which they have made available on                        the market are not in conformity with this Directive shall make sure that the corrective measures necessary to bring that                        equipment or assembly into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the pressure                        equipment or assembly presents a risk, distributors shall immediately inform the competent national authorities of the Member                        States in which they made the equipment or assembly available on the market to that effect, giving details, in particular,                        of the non-compliance and of any corrective measures taken.                  

5.Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information                        and documentation necessary to demonstrate the conformity of pressure equipment or assemblies. That information and documentation                        may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken                        to eliminate the risks posed by the pressure equipment or assemblies which they have made available on the market.                  

### Article 10U.K.Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to                     the obligations of the manufacturer under Article 6, where he places pressure equipment or an assembly on the market under                     his name or trademark or modifies pressure equipment or an assembly already placed on the market in such a way that compliance                     with the requirements of this Directive may be affected.                  

### Article 11U.K.Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

any economic operator who has supplied them with pressure equipment or an assembly;

any economic operator to whom they have supplied pressure equipment or an assembly.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have                     been supplied with the pressure equipment or assembly and for 10 years after they have supplied the pressure equipment or                     assembly.                  

## CHAPTER 3U.K.**CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES**

### Article 12U.K.Presumption of conformity

1.Pressure equipment or assemblies referred to in Article 4(1) and (2) which are in conformity with harmonised standards or                        parts thereof the references of which have been published in the *Official Journal of the European Union* shall be presumed to be in conformity with the essential safety requirements covered by those standards or parts thereof,                        referred to in Annex I.                  

2.The materials used for the manufacture of pressure equipment or assemblies which are in conformity with European approvals                        for materials, the references of which have been published in the *Official Journal of the European Union* in accordance with Article 15(4), shall be presumed to be in conformity with the applicable essential safety requirements                        set out in Annex I.                  

### Article 13U.K.Classification of pressure equipment

1.Pressure equipment referred to in Article 4(1) shall be classified by category in accordance with Annex II, according to an                        ascending level of hazard.                  

For the purposes of such classification fluids shall be divided into the following two groups:

(a)group 1 consisting of substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC) No 1272/2008,                        that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and                        3 of Annex I to that Regulation:                  

unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;

flammable gases, category 1 and 2;

oxidising gases, category 1;

flammable liquids, category 1 and 2;

flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;

flammable solids, category 1 and 2;

self-reactive substances and mixtures, type A to F;

pyrophoric liquids, category 1;

pyrophoric solids, category 1;

substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;

oxidising liquids, category 1, 2 and 3;

oxidising solids, category 1, 2 and 3;

organic peroxides types A to F;

acute oral toxicity, category 1 and 2;

acute dermal toxicity, category 1 and 2;

acute inhalation toxicity, category 1, 2 and 3;

specific target organ toxicity – single exposure, category 1.

Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which                     exceeds the flashpoint of the fluid;                  

(b)group 2 consisting of substances and mixtures not referred to in point (a).                  

2.Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual                        chambers. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest                        category.                  

### Article 14U.K.Conformity assessment procedures

1.The conformity assessment procedures to be applied to an item of pressure equipment shall be determined by the category, as                        set out in Article 13, in which the equipment is classified.                  

2.The conformity assessment procedures to be applied for the various categories are the following:                  

(a)category I:                  
          -  (a)Module A 

(b)category II:                  
          -  (b)Module A2 
          -  Module D1 
          -  Module E1 

(c)category III:                  
          -  (c)Modules B (design type) + D 
          -  Modules B (design type) + F 
          -  Modules B (production type) + E 
          -  Modules B (production type) + C2 
          -  Module H 

(d)category IV:                  
          -  (d)Modules B (production type) + D 
          -  Modules B (production type) + F 
          -  Module G 
          -  Module H1 

The conformity assessment procedures are set out in Annex III.

3.Pressure equipment shall be subject to one of the conformity assessment procedures which may be chosen by the manufacturer                        among those laid down for the category in which it is classified. The manufacturer may also choose to apply one of the procedures                        which apply to a higher category, if available.                  

4.In the framework of quality assurance procedures for pressure equipment in categories III and IV referred to in point (i)                        of point (a) of Article 4(1), first indent of point (ii) of point (a) of Article 4(1) and point (b) of Article 4(1), the notified                        body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order                        to perform, or have performed, the final assessment as referred to in Annex I, point 3.2. To this end, the manufacturer shall                        inform the notified body of the intended schedule of production. The notified body shall carry out at least two visits during                        the first year of manufacturing. The frequency of subsequent visits shall be determined by the notified body on the basis                        of the criteria set out in point 4.4 of modules D, E and H and point 5.4 of module H1.                  

5.In the case of one-off production of vessels and pressure equipment in category III referred to in point (b) of Article 4(1)                        under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in point                        3.2 of Annex I, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the                        notified body.                  

6.Assemblies referred to in Article 4(2) shall be subject to a global conformity assessment procedure comprising the following                        assessments:                  

(a)the assessment of each item of pressure equipment making up the assembly and referred to in Article 4(1) which has not been                        previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be                        determined by the category of each item of equipment;                  

(b)the assessment of the integration of the various components of the assembly as referred to in points 2.3, 2.8 and 2.9 of Annex                        I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any                        safety accessories;                  

(c)the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in points                        2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to                        be protected.                  

7.By way of derogation from paragraphs 1 and 2 of this Article, the competent authorities may, where justified, allow the making                        available on the market and putting into service in the territory of the Member State concerned of individual pressure equipment                        items and assemblies referred to in Article 2, in respect of which the procedures referred to in paragraphs 1 and 2 of this                        Article have not been applied and the use of which is in the interests of experimentation.                  

8.The records and correspondence relating to conformity assessment procedures shall be drafted in an official language of the                        Member State where the body responsible for carrying out these conformity assessment procedures is established, or in a language                        accepted by that body.                  

### Article 15U.K.European approval for materials

1.European approval for materials shall be issued at the request of one or more manufacturers of materials or equipment, by                        one of the notified bodies referred to in Article 20 specifically designated for that task. The notified body shall determine                        and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types                        of material with the corresponding requirements of this Directive. In the case of materials recognised as being safe to use                        before 29 November 1999, the notified body shall take account of the existing data when certifying such conformity.                  

2.Before issuing a European approval for materials, the notified body shall notify the Member States and the Commission by sending                        them the appropriate information. Within three months, a Member State or the Commission may provide comments giving its reasons.                        The notified body may issue the European approval for materials taking into account the comments submitted.                  

3.A copy of the European approval for materials shall be sent to the Member States, the notified bodies and the Commission.                  

4.When the European approval for materials satisfies the requirements which it covers and which are set out in Annex I, the                        Commission shall publish the references of that approval. The Commission shall keep up to date a list of such approvals in                        the *Official Journal of the European Union*.                  

5.The notified body which issued the European approval for materials shall withdraw that approval if it finds that it should                        not have been issued or if the type of materials is covered by a harmonised standard. It shall immediately inform the other                        Member States, the notified bodies and the Commission of any withdrawal of an approval.                  

6.When a Member State or the Commission considers that a European approval for materials whose references have been published                        in the *Official Journal of the European Union*, does not entirely satisfy the essential safety requirements which it covers and which are set out in Annex I, the Commission                        shall decide by means of implementing acts whether to withdraw the references of that European approval for materials from                        the *Official Journal of the European Union*.                  

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination                     procedure referred to in Article 44(3).                  

### Article 16U.K.User inspectorates

1.By way of derogation from the provisions relating to the tasks carried out by the notified bodies, Member States may authorise                        on their territory the placing on the market and the putting into service by users, of pressure equipment or assemblies of                        which conformity with the essential safety requirements has been assessed by a user inspectorate designated in accordance                        with paragraph 7.                  

2.Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall not bear the CE marking.                  

3.The pressure equipment or assemblies referred to in paragraph 1 may be used only in establishments operated by the group of                        which the inspectorate is part. The group shall apply a common safety policy as regards the technical specifications for the                        design, manufacture, inspection, maintenance and use of pressure equipment and assemblies.                  

4.The user inspectorates shall act exclusively for the group of which they are part.                  

5.The conformity assessment procedures applicable by user inspectorates shall be modules A2, C2, F and G, set out in Annex III.                  

6.Member States shall notify the other Member States and the Commission which user inspectorates they have authorised, the tasks                        for which they have been designated and, for each inspectorate, a list of the establishments satisfying the provisions of                        paragraph 3.                  

7.In designating the user inspectorates, the Member States shall apply the requirements set out in Article 25 and ensure that                        the group of which the inspectorate is part applies the criteria referred to in the second sentence of paragraph 3 of this                        Article.                  

### Article 17U.K.EU declaration of conformity

1.The EU declaration of conformity shall state that the fulfilment of essential safety requirements set out in Annex I has been                        demonstrated.                  

2.The EU declaration of conformity shall have the model structure set out in Annex IV and shall contain the elements specified                        in the relevant conformity assessment procedures set out in Annex III and shall be continuously updated. It shall be translated                        into the language or languages required by the Member State in whose market the pressure equipment or assembly is placed or                        made available on the market.                  

3.Where pressure equipment or an assembly is subject to more than one Union act requiring an EU declaration of conformity, a                        single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the                        identification of the Union acts concerned including their publication references.                  

4.By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the pressure                        equipment or assembly with the requirements laid down in this Directive.                  

### Article 18U.K.General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

### Article 19U.K.Rules and conditions for affixing the CE marking

1.The CE marking shall be affixed visibly, legibly and indelibly to any of the following:                  

(a)each item of pressure equipment referred to in Article 4(1) or its dataplate;                  

(b)each assembly referred to in Article 4(2) or its dataplate.                  

Where the affixing of the CE marking is not possible or not warranted on account of the nature of the equipment or assembly,                     it shall be affixed to the packaging and to the accompanying documents.                  

The item or assembly referred to in points (a) and (b) of the first subparagraph shall be complete or shall be in a state                     permitting final assessment as described in point 3.2 of Annex I.                  

2.It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly.                        Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to                        bear that marking.                  

3.The CE marking shall be affixed before the item of pressure equipment or the assembly is placed on the market.                  

4.The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production                        control phase.                  

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer                     or his authorised representative.                  

5.The CE marking and, where applicable, the identification number referred to in paragraph 4 may be followed by any other mark                        indicating a special risk or use.                  

6.Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and                        shall take appropriate action in the event of improper use of that marking.                  

## CHAPTER 4U.K.**NOTIFICATION OF CONFORMITY ASSESSMENT BODIES**

### Article 20U.K.Notification

Member States shall notify the Commission and the other Member States of the notified bodies and the user inspectorates authorised                     to carry out conformity assessment tasks in accordance with Article 14, Article 15 or Article 16 and of the third-party organisations                     they have recognised, for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of Annex I.                  

### Article 21U.K.Notifying authorities

1.Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary                        procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, recognised                        third-party organisations and user inspectorates, including compliance with Article 27.                  

2.Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national                        accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.                  

3.Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph                        1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the                        requirements laid down in Article 22. In addition it shall have arrangements to cover liabilities arising out of its activities.                  

4.The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.                  

### Article 22U.K.Requirements relating to notifying authorities

1.A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.                  

2.A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.                  

3.A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment                        body is taken by competent persons different from those who carried out the assessment.                  

4.A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services                        on a commercial or competitive basis.                  

5.A notifying authority shall safeguard the confidentiality of the information it obtains.                  

6.A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of                        its tasks.                  

### Article 23U.K.Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment                     bodies and the monitoring of notified bodies, recognised third-party organisations and user inspectorates, and of any changes                     thereto.                  

The Commission shall make that information publicly available.

### Article 24U.K.Requirements relating to notified bodies and recognised third-party organisations

1.For the purposes of notification, a notified body or recognised third party organisation shall meet the requirements laid                        down in paragraphs 2 to 11.                  

2.A conformity assessment body shall be established under national law of a Member State and have legal personality.                  

3.A conformity assessment body shall be a third-party body independent of the organisation or the pressure equipment or assembly                        it assesses.                  

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing,                     provision, assembly, use or maintenance of pressure equipment or assemblies which it assesses, may, on condition that its                     independence and the absence of any conflict of interest are demonstrated, be considered such a body.                  

4.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment                        tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the pressure equipment                        or assembly which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed                        pressure equipment or assemblies that are necessary for the operations of the conformity assessment body or the use of such                        equipment for personal purposes.                  

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment                     tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance                     of that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any                     activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities                     for which they are notified. This shall in particular apply to consultancy services.                  

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality,                     objectivity or impartiality of their conformity assessment activities.                  

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree                        of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures                        and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment                        activities, especially as regards persons or groups of persons with an interest in the results of those activities.                  

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Article                        14 or Article 15, or points 3.1.2 and 3.1.3 of Annex I and in relation to which it has been notified, whether those tasks                        are carried out by the conformity assessment body itself or on its behalf and under its responsibility.                  

At all times and for each conformity assessment procedure and each kind or category of pressure equipment in relation to which                     it has been notified, a conformity assessment body shall have at its disposal the necessary:                  

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;                  

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the                        ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between                        tasks it carries out as a conformity assessment body and other activities;                  

(c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it                        operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the                        production process.                  

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with                     the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.                  

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:                  

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity                        assessment body has been notified;                  

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;                  

(c)appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonised                        standards and of the relevant provisions of Union harmonisation legislation and of national legislation;                  

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.                  

8.The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying                        out the conformity assessment tasks shall be guaranteed.                  

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of                     a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.                  

9.Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with                        national law, or the Member State itself is directly responsible for the conformity assessment.                  

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in                        carrying out their tasks under Article 14, Article 15, or under points 3.1.2 and 3.1.3 of Annex I or any provision of national                        law giving effect to them, except in relation to the competent authorities of the Member State in which its activities are                        carried out. Proprietary rights shall be protected.                  

11.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out conformity                        assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination                        group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative                        decisions and documents produced as a result of the work of that group.                  

### Article 25U.K.Requirements relating to user inspectorates

1.For the purposes of notification, a user inspectorate shall meet the requirements laid down in paragraphs 2 to 11.                  

2.A user inspectorate shall be established under national law of a Member State and have legal personality.                  

3.A user inspectorate shall be organisationally identifiable and have reporting methods within the group of which it is part                        which ensure and demonstrate its impartiality.                  

4.A user inspectorate, its top level management and the personnel responsible for carrying out the conformity assessment tasks                        shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the pressure equipment                        or assembly which they assess, nor the authorised representative of any of those parties. This shall not preclude the use                        of assessed pressure equipment or assemblies that are necessary for the operations of the user inspectorate or the use of                        such equipment for personal purposes.                  

A user inspectorate, its top level management and the personnel responsible for carrying out the conformity assessment tasks                     shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance                     of that pressure equipment or assembly, or represent the parties engaged in those activities. They shall not engage in any                     activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities                     for which they are notified. This shall in particular apply to consultancy services.                  

5.User inspectorates and their personnel shall carry out the conformity assessment activities with the highest degree of professional                        integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements,                        particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially                        as regards persons or groups of persons with an interest in the results of those activities.                  

6.A user inspectorate shall be capable of carrying out all the conformity assessment tasks assigned to it by Article 16 and                        in relation to which it has been notified, whether those tasks are carried out by the user inspectorate itself or on its behalf                        and under its responsibility.                  

At all times and for each conformity assessment procedure and each kind or category of pressure equipment in relation to which                     it has been notified, the user inspectorate shall have at its disposal the necessary:                  

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;                  

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the                        ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between                        tasks it carries out as a user inspectorate and other activities;                  

(c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it                        operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the                        production process.                  

A user inspectorate shall have the means necessary to perform the technical and administrative tasks connected with the conformity                     assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.                  

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:                  

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity                        assessment body has been notified;                  

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;                  

(c)appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonised                        standards and of the relevant provisions of Union harmonisation legislation and of national legislation;                  

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.                  

8.The impartiality of the user inspectorates, their top level management and of the personnel responsible for carrying out conformity                        assessment tasks shall be guaranteed. User inspectorates must not engage in any activities that might conflict with its independence                        of judgement and integrity in relation to its inspection activities.                  

The remuneration of the top level management and personnel responsible for carrying out conformity assessment tasks of a user                     inspectorate shall not depend on the number of assessments carried out or on the results of those assessments.                  

9.User inspectorates shall take out liability insurance unless liability is assumed by the group of which they are part.                  

10.The personnel of user inspectorates shall observe professional secrecy with regard to all information obtained in carrying                        out their tasks under Article 16 or any provision of national law giving effect to them, except in relation to the competent                        authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.                  

11.User inspectorates shall participate in, or ensure that their personnel responsible for carrying out conformity assessment                        tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group                        established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions                        and documents produced as a result of the work of that group.                  

### Article 26U.K.Presumption of conformity of conformity assessment bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards                     or parts thereof the references of which have been published in the *Official Journal of the European Union* it shall be presumed to comply with the requirements set out in Article 24 or Article 25 in so far as the applicable harmonised                     standards cover those requirements.                  

### Article 27U.K.Subsidiaries of and subcontracting by conformity assessment bodies

1.Where a notified body, a user inspectorate or a recognised third-party organisation subcontracts specific tasks connected                        with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets                        the requirements set out in Article 24 or Article 25 and shall inform the notifying authority accordingly.                  

2.Notified bodies, user inspectorates and recognised third-party organisations shall take full responsibility for the tasks                        performed by subcontractors or subsidiaries wherever these are established.                  

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.                  

4.Notified bodies, user inspectorates and recognised third-party organisations shall keep at the disposal of the notifying authority                        the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work                        carried out by them under Article 14, Article 15, Article 16 or points 3.1.2 and 3.1.3 of Annex I.                  

### Article 28U.K.Application for notification

1.A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in                        which it is established.                  

2.The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity                        assessment module or modules and the pressure equipment for which that body claims to be competent, as well as by an accreditation                        certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils                        the requirements laid down in Article 24 or Article 25.                  

3.Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying                        authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance                        with the requirements laid down in Article 24 or Article 25.                  

### Article 29U.K.Notification procedure

1.Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article                        24 or Article 25.                  

2.They shall notify the Commission and the other Member States using the electronic notification tool developed and managed                        by the Commission.                  

3.The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules                        and the pressure equipment concerned and the relevant attestation of competence.                  

4.Where a notification is not based on an accreditation certificate as referred to in Article 28(2), the notifying authority                        shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment                        body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to                        satisfy the requirements laid down in Article 24 or Article 25.                  

5.The body concerned may perform the activities of a notified body, a recognised third-party organisation or a user inspectorate                        only where no objections are raised by the Commission or the other Member States within two weeks of a notification where                        an accreditation certificate is used or within two months of a notification where accreditation is not used.                  

Only such a body shall be considered a notified body, a recognised third-party organisation or a user inspectorate for the                     purposes of this Directive.                  

6.The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the                        notification.                  

### Article 30U.K.Identification numbers and lists of notified bodies

1.The Commission shall assign an identification number to a notified body.                  

It shall assign a single such number even where the body is notified under several Union acts.

2.The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification                        numbers that have been assigned to them and the activities for which they have been notified.                  

The Commission shall ensure that the list is kept up to date.

### Article 31U.K.Lists of recognised third-party organisations and user inspectorates

The Commission shall make publicly available the list of the recognised third-party organisations and of the user inspectorates                     under this Directive and the tasks for which they have been recognised.                  

The Commission shall ensure that the list is kept up to date.

### Article 32U.K.Changes to notifications

1.Where a notifying authority has ascertained or has been informed that a notified body or a recognised third-party organisation                        no longer meets the requirements laid down in Article 24 or that it is failing to fulfil its obligations, the notifying authority                        shall, as appropriate, restrict, suspend or withdraw the notification, depending on the seriousness of the failure to meet                        those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.                  

Where a notifying authority has ascertained or has been informed that a user inspectorate no longer meets the requirements                     laid down in Article 25, or that it is failing to fulfil its obligations, the notifying authority shall as appropriate, restrict,                     suspend or withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those                     obligations. It shall immediately inform the Commission and the other Member States accordingly.                  

2.In the event of restriction, suspension or withdrawal of notification, or where the notified body, the recognised third-party                        organisation or the user inspectorate has ceased its activity, the notifying Member State shall take appropriate steps to                        ensure that the files of that body are either processed by another notified body, recognised third-party organisation or user                        inspectorate, or kept available for the responsible notifying and market surveillance authorities at their request.                  

### Article 33U.K.Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates

1.The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence                        of a notified body, a recognised third-party organisation or a user inspectorate, or the continued fulfilment by a notified                        body, a recognised third-party organisation or a user inspectorate of the requirements and responsibilities to which it is                        subject.                  

2.The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification                        or the maintenance of the competence of the conformity assessment body concerned.                  

3.The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.                  

4.Where the Commission ascertains that a notified body, a recognised third-party organisation or a user inspectorate does not                        meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying                        Member State to take the necessary corrective measures, including withdrawal of notification if necessary.                  

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).

### Article 34U.K.Operational obligations of notified bodies, user inspectorates and recognised third party organisations

1.Notified bodies, user inspectorates and recognised third-party organisations shall carry out conformity assessments in accordance                        with the conformity assessment tasks provided for in Article 14, Article 15, Article 16, or in points 3.1.2 and 3.1.3 of Annex                        I.                  

2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.                  

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in                     which it operates, its structure, the degree of complexity of the pressure equipment or assembly technology in question and                     the mass or serial nature of the production process.                  

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of                     the pressure equipment with the requirements of this Directive.                  

3.Where a conformity assessment body finds that essential safety requirements set out in Annex I or corresponding harmonised                        standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take                        appropriate corrective measures and shall not issue a certificate of conformity.                  

4.Where, in the course of the monitoring of conformity following the issue of a certificate, a conformity assessment body finds                        that pressure equipment no longer complies, it shall require the manufacturer to take appropriate corrective measures and                        shall suspend or withdraw the certificate if necessary.                  

5.Where corrective measures are not taken or do not have the required effect, the conformity assessment body shall restrict,                        suspend or withdraw any certificates, as appropriate.                  

### Article 35U.K.Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates

Member States shall ensure that appeal procedures against decisions of notified bodies, recognised third-party organisations                     and user inspectorates are available.                  

### Article 36U.K.Information obligation on notified bodies, recognised third party organisations and user inspectorates

1.Notified bodies, recognised third-party organisations and user inspectorates shall inform the notifying authority of the following:                  

(a)any refusal, restriction, suspension or withdrawal of a certificate;                  

(b)any circumstances affecting the scope of or conditions for notification;                  

(c)any request for information which they have received from market surveillance authorities regarding conformity assessment                        activities;                  

(d)on request, conformity assessment activities performed within the scope of their notification and any other activity performed,                        including cross-border activities and subcontracting.                  

2.Notified bodies, recognised third-party organisations and user inspectorates shall provide the other bodies notified under                        this Directive carrying out similar conformity assessment activities covering the same pressure equipment with relevant information                        on issues relating to negative and, on request, positive conformity assessment results.                  

### Article 37U.K.Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities                     responsible for notification policy.                  

### Article 38U.K.Coordination of notified bodies, recognised third-party organisations and user inspectorates

The Commission shall ensure that appropriate coordination and cooperation between the conformity assessment bodies notified                     under this Directive are put in place and properly operated in the form of a sectoral group or groups of conformity assessment                     bodies.                  

Member States shall ensure that the conformity assessment bodies notified by them participate in the work of that or those                     group or groups, directly or by means of designated representatives.                  

## CHAPTER 5U.K.**UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE**

### Article 39U.K.Union market surveillance and control of pressure equipment and assemblies entering the Union market

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies covered                     by Article 1 of this Directive.                  

### Article 40U.K.Procedure for dealing with pressure equipment or assemblies presenting a risk at national level

1.Where the market surveillance authorities of one Member State have sufficient reasons to believe that pressure equipment or                        assemblies covered by this Directive present a risk to the health or safety of persons or to domestic animals or property,                        they shall carry out an evaluation in relation to the pressure equipment or assembly concerned covering all relevant requirements                        laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities                        for that purpose.                  

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that                     the equipment or assembly does not comply with the requirements laid down in this Directive, they shall without delay require                     the relevant economic operator to take all appropriate corrective actions to bring the pressure equipment or assembly into                     compliance with those requirements, to withdraw the equipment or assembly from the market, or to recall it within a reasonable                     period, commensurate with the nature of the risk, as they may prescribe.                  

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2.Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they                        shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have                        required the economic operator to take.                  

3.The economic operator shall ensure that all appropriate corrective action is taken in respect of all the pressure equipment                        and assemblies concerned that it has made available on the market throughout the Union.                  

4.Where the relevant economic operator does not take adequate corrective action within the period referred to in the second                        subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit                        or restrict the equipment’s or assembly’s being made available on their national market, to withdraw the equipment or assembly                        from that market or to recall it.                  

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

5.The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the                        data necessary for the identification of the non-compliant equipment or assembly, the origin of the equipment or assembly,                        the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and                        the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate                        whether the non-compliance is due to either of the following:                  

(a)failure of the equipment or assembly to meet requirements relating to the health or safety of persons or to the protection                        of domestic animals or property; or                  

(b)shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.                  

6.Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission                        and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance                        of the equipment or assembly concerned, and, in the event of disagreement with the adopted national measure, of their objections.                  

7.Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection                        has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that                        measure shall be deemed justified.                  

8.Member States shall ensure that appropriate restrictive measures, such as withdrawal of the equipment or assembly from the                        market, are taken in respect of the equipment or assembly concerned without delay.                  

### Article 41U.K.Union safeguard procedure

1.Where, on completion of the procedure set out in Article 40(3) and (4), objections are raised against a measure taken by a                        Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall                        without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate                        the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining                        whether the national measure is justified or not.                  

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant                     economic operator or operators.                  

2.If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant                        equipment or assembly is withdrawn from their market, and shall inform the Commission accordingly. If the national measure                        is considered unjustified, the Member State concerned shall withdraw that measure.                  

3.Where the national measure is considered justified and the non-compliance of the equipment or assembly is attributed to shortcomings                        in the harmonised standards referred to in point (b) of Article 40(5) of this Directive, the Commission shall apply the procedure                        provided for in Article 11 of Regulation (EU) No 1025/2012.                  

### Article 42U.K.Compliant pressure equipment or assemblies which present a risk

1.Where, having carried out an evaluation under Article 40(1), a Member State finds that although pressure equipment or an assembly                        is in compliance with this Directive, it presents a risk to the health or safety of persons, to domestic animals or property,                        it shall require the relevant economic operator to take all appropriate measures to ensure that the equipment or assembly                        concerned, when placed on the market, no longer presents that risk, to withdraw the equipment or assembly from the market                        or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.                  

2.The economic operator shall ensure that corrective action is taken in respect of all the equipment or assemblies concerned                        that he has made available on the market throughout the Union.                  

3.The Member State shall immediately inform the Commission and the other Member States. That information shall include all available                        details, in particular the data necessary for the identification of the equipment or assembly concerned, the origin and the                        supply chain of the equipment or assembly, the nature of the risk involved and the nature and duration of the national measures                        taken.                  

4.The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators                        and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide                        by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures.                  

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination                     procedure referred to in Article 44(3).                  

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, or of domestic                     animals or of property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure                     referred to in Article 44(4).                  

5.The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant                        economic operator or operators.                  

### Article 43U.K.Formal non-compliance

1.Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic                        operator to put an end to the non-compliance concerned:                  

(a)the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 19 of this Directive;                  

(b)the CE marking has not been affixed;                  

(c)the identification number of the notified body involved in the production control phase, has been affixed in violation of                        Article 19 or has not been affixed;                  

(d)the marking and labelling referred to in point 3.3. of Annex I have not been affixed or have been affixed in violation of                        Article 19 or point 3.3 of Annex I;                  

(e)the EU declaration of conformity has not been drawn up;                  

(f)the EU declaration of conformity has not been drawn up correctly;                  

(g)the technical documentation is either not available or not complete;                  

(h)the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;                  

(i)any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.                  

2.Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures                        to restrict or prohibit the equipment or assembly being made available on the market or ensure that it is recalled or withdrawn                        from the market.                  

## CHAPTER 6U.K.**COMMITTEE PROCEDURE AND DELEGATED ACTS**

### Article 44U.K.Committee procedure

1.The Commission shall be assisted by the Committee on Pressure Equipment. That committee shall be a committee within the meaning                        of Regulation (EU) No 182/2011.                  

2.Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.                  

3.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.                  

4.Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof,                        shall apply.                  

5.The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by                        Regulation (EU) No 1025/2012 or by any other Union legislation.                  

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair                     or by a representative of a Member State in accordance with its rules of procedure.                  

### Article 45U.K.Delegated power

1.In order to take into account emerging very serious safety reasons, the Commission shall be empowered to adopt delegated acts                        in accordance with Article 46 reclassifying pressure equipment or assemblies so as to:                  

(a)make an item or family of pressure equipment referred to in Article 4(3) subject to the requirements of Article 4(1);                  

(b)make an assembly or family of assemblies referred to in Article 4(3) subject to the requirements of Article 4(2);                  

(c)classify an item or family of pressure equipment, by way of derogation from the requirements of Annex II, in another category.                  

2.A Member State having concerns about the safety of pressure equipment or assemblies shall immediately inform the Commission                        of its concerns and provide reasons in support.                  

3.Prior to adopting a delegated act the Commission shall carry out a thorough assessment of the risks that require reclassification.                  

### Article 46U.K.Exercise of the delegation

1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.                  

2.The power to adopt delegated acts referred to in Article 45 shall be conferred on the Commission for a period of five years                        from 1 June 2015. The Commission shall draw up a report in respect of the delegation of power not later than nine months before                        the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless                        the European Parliament or the Council opposes such extension not later than three months before the end of each period.                  

3.The delegation of power referred to in Article 45 may be revoked at any time by the European Parliament or by the Council.                        A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the                        day following the publication of the decision in the *Official Journal of the European Union* or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.                  

4.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the                        Council.                  

5.A delegated act adopted pursuant to Article 45 shall enter into force only if no objection has been expressed either by the                        European Parliament or the Council within a period of two months of notification of that act to the European Parliament and                        the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission                        that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of                        the Council.                  

## CHAPTER 7U.K.**TRANSITIONAL AND FINAL PROVISIONS**

### Article 47U.K.Penalties

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national                     law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. Such rules                     may include criminal penalties for serious infringements.                  

The penalties referred to in the first paragraph shall be effective, proportionate and dissuasive.

### Article 48U.K.Transitional provisions

1.Member States shall not impede the putting into service of pressure equipment and assemblies which comply with the regulations                        in force in their territory at the date of application of Directive 97/23/EC and were placed on the market until 29 May 2002.                  

2.Member States shall not impede the making available on the market and/or the putting into service of pressure equipment or                        assemblies covered by Directive 97/23/EC which are in conformity with that Directive and which were placed on the market before                        1 June 2015.                  

3.Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under this Directive.                  

### Article 49U.K.Transposition

1.Member States shall adopt and publish, by 28 February 2015, the laws, regulations and administrative provisions necessary                        to comply with Article 13. They shall forthwith communicate the text of those measures to the Commission.                  

They shall apply those measures from 1 June 2015.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference                     on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations                     and administrative provisions to Article 9 of Directive 97/23/EC shall be construed as references to Article 13 of this Directive.                     Member States shall determine how such reference is to be made and how that statement is to be formulated.                  

2.Member States shall adopt and publish, by 18 July 2016, the laws, regulations and administrative provisions necessary to comply                        with Article 2(15) to (32), Articles 6 to 12, 14, 17 and 18, Article 19(3) to (5), Articles 20 to 43, 47 and 48 and Annexes                        I, II, III and IV. They shall forthwith communicate the text of those measures to the Commission.                  

They shall apply those measures from 19 July 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference                     on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations                     and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive.                     Member States shall determine how such reference is to be made and how that statement is to be formulated.                  

3.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the                        field governed by this Directive.                  

### Article 50U.K.Repeal

Article 9 of Directive 97/23/EC is deleted with effect from 1 June 2015, without prejudice to the obligations of the Member                     States relating to the time-limit for transposition into national law and the date of application of that Article, set out                     in Annex V, Part B.                  

Directive 97/23/EC, as amended by the acts listed in Annex V, Part A, is repealed with effect from 19 July 2016, without prejudice                     to the obligations of the Member States relating to the time-limit for transposition into national law and the date of application                     of the Directive set out in Annex V, Part B.                  

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with                     the correlation table in Annex VI.                  

### Article 51U.K.Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

Article 1, points 1 to 14 of Article 2, Articles 3, 4, 5, 14, 15 and 16, Article 19(1) and (2), and Articles 44, 45 and 46                     shall apply from 19 July 2016.                  

### Article 52U.K.Addressees

This Directive is addressed to the Member States.

Done at Brussels, 15 May 2014.

*For the European Parliament*                            

*The President*                            

M. Schulz                            

*For the Council*                            

*The President*                            

D. Kourkoulas                            

## ANNEX IU.K.**ESSENTIAL SAFETY REQUIREMENTS**

### **PRELIMINARY OBSERVATIONS**U.K.

#### 1.The obligations arising from the essential safety requirements listed in this Annex for pressure equipment also apply to assemblies                        where the corresponding hazard exists.U.K.

#### 2.The essential safety requirements laid down in this Directive are compulsory. The obligations following from those essential                        safety requirements apply only if the corresponding hazard exists for the pressure equipment in question when it is used under                        conditions which are reasonably foreseeable by the manufacturer.U.K.

#### 3.The manufacturer is under an obligation to analyse the hazards and risks in order to identify those which apply to his equipment                        on account of pressure; he shall then design and construct it taking account of his analysis.U.K.

#### 4.The essential safety requirements are to be interpreted and applied in such a way as to take account of the state of the art                        and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent                        with a high degree of health and safety protection.U.K.

#### 1.GENERALU.K.

##### 1.1.Pressure equipment shall be designed, manufactured and checked, and if applicable equipped and installed, in such a way as                        to ensure its safety when put into service in accordance with the manufacturer’s instructions, or in reasonably foreseeable                        conditions.U.K.

##### 1.2.In choosing the most appropriate solutions, the manufacturer shall apply the principles set out below in the following order:U.K.

          -  eliminate or reduce hazards as far as is reasonably practicable; 
          -  apply appropriate protection measures against hazards which cannot be eliminated; 
          -  where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures                           to reduce the risks at the time of installation and/or use.                         

##### 1.3.Where the potential for misuse is known or can be clearly foreseen, the pressure equipment shall be designed to prevent risks                        from such misuse or, if that is not possible, adequate warning given that the pressure equipment shall not be used in that                        way.U.K.

#### 2.DESIGNU.K.

##### 2.1.**General**U.K.

The pressure equipment shall be properly designed taking all relevant factors into account in order to ensure that the equipment                     will be safe throughout its intended life.                  

The design shall incorporate appropriate safety coefficients using comprehensive methods which are known to incorporate adequate                     safety margins against all relevant failure modes in a consistent manner.                  

##### 2.2.**Design for adequate strength**U.K.

###### 2.2.1.The pressure equipment shall be designed for loadings appropriate to its intended use and other reasonably foreseeable operating                        conditions. In particular, the following factors shall be taken into account:U.K.

          -  internal/external pressure, 
          -  ambient and operational temperatures, 
          -  static pressure and mass of contents in operating and test conditions, 
          -  traffic, wind, earthquake loading, 
          -  reaction forces and moments which result from the supports, attachments, piping, etc., 
          -  corrosion and erosion, fatigue, etc., 
          -  decomposition of unstable fluids. 

Various loadings which can occur at the same time shall be considered, taking into account the probability of their simultaneous                     occurrence.                  

###### 2.2.2.Design for adequate strength shall be based on either of the following:U.K.

          -  as a general rule, a calculation method, as described in point 2.2.3, and supplemented if necessary by an experimental design                           method as described in point 2.2.4,                         
          -  an experimental design method without calculation, as described in point 2.2.4, when the product of the maximum allowable                           pressure PS and the volume V is less than 6 000 bar·L or the product PS·DN less than 3 000 bar.                         

###### 2.2.3.*Calculation method*U.K.

###### (a)*Pressure containment and other loading aspects*U.K.

The allowable stresses for pressure equipment shall be limited having regard to reasonably foreseeable failure modes under                     operating conditions. To this end, safety factors shall be applied to eliminate fully any uncertainty arising out of manufacture,                     actual operational conditions, stresses, calculation models and the properties and behaviour of the material.                  

These calculation methods shall provide sufficient safety margins consistent, where applicable, with the requirements of point                     7.                  

The requirements set out above may be met by applying one of the following methods, as appropriate, if necessary as a supplement                     to or in combination with another method:                  
          -  design by formula, 
          -  design by analysis, 
          -  design by fracture mechanics. 

###### (b)*Resistance*U.K.

Appropriate design calculations shall be used to establish the resistance of the pressure equipment concerned.

In particular:
          -  the calculation pressures shall not be less than the maximum allowable pressures and take into account static head and dynamic                           fluid pressures and the decomposition of unstable fluids. Where a vessel is separated into individual pressure-containing                           chambers, the partition wall shall be designed on the basis of the highest possible chamber pressure relative to the lowest                           pressure possible in the adjoining chamber,                         
          -  the calculation temperatures shall allow for appropriate safety margins, 
          -  the design shall take appropriate account of all possible combinations of temperature and pressure which might arise under                           reasonably foreseeable operating conditions for the equipment,                         
          -  the maximum stresses and peak stress concentrations shall be kept within safe limits, 
          -  the calculation for pressure containment shall utilise the values appropriate to the properties of the material, based on                           documented data, having regard to the provisions set out in point 4 together with appropriate safety factors. Material characteristics                           to be considered, where applicable, include:                                      -  yield strength, 0,2 % or 1,0 % proof strength as appropriate at calculation temperature, 
            -  tensile strength, 
            -  time-dependent strength, i.e. creep strength, 
            -  fatigue data, 
            -  Young’s modulus (modulus of elasticity), 
            -  appropriate amount of plastic strain, 
            -  bending rupture energy, 
            -  fracture toughness. 
          -  appropriate joint factors shall be applied to the material properties depending, for example, on the type of non-destructive                           testing, the materials joined and the operating conditions envisaged,                         
          -  the design shall take appropriate account of all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue)                           commensurate with the intended use of the equipment. Attention shall be drawn, in the instructions referred to in point 3.4,                           to particular features of the design which are relevant to the life of the equipment, for example:                                      -  for creep: design hours of operation at specified temperatures, 
            -  for fatigue: design number of cycles at specified stress levels, 
            -  for corrosion: design corrosion allowance. 

###### (c)*Stability aspects*U.K.

Where the calculated thickness does not allow for adequate structural stability, the necessary measures shall be taken to                     remedy the situation taking into account the risks from transport and handling.                  

###### 2.2.4.*Experimental design method*U.K.

The design of the equipment may be validated, in all or in part, by an appropriate test programme carried out on a sample                     representative of the equipment or the category of equipment.                  

The test programme shall be clearly defined prior to testing and accepted by the notified body responsible for the design                     conformity assessment module, where it exists.                  

This programme shall define test conditions and criteria for acceptance or refusal. The actual values of the essential dimensions                     and characteristics of the materials which constitute the equipment tested shall be measured before the test.                  

Where appropriate, during tests, it shall be possible to observe the critical zones of the pressure equipment with adequate                     instrumentation capable of registering strains and stresses with sufficient precision.                  

The test programme shall include:

A pressure strength test, the purpose of which is to check that, at a pressure with a defined safety margin in relation to                              the maximum allowable pressure, the equipment does not exhibit significant leaks or deformation exceeding a determined threshold.                           

The test pressure shall be determined on the basis of the differences between the values of the geometrical and material characteristics                              measures under test conditions and the values used for design purposes; it shall take into account the differences between                              the test and design temperatures;                           

where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for                              the equipment, for instance hold time at specified temperatures, number of cycles at specified stress-levels;                           

where necessary, additional tests concerning other factors referred to in point 2.2.1 such as corrosion, external damage.

##### 2.3.**Provisions to ensure safe handling and operation**U.K.

The method of operation specified for pressure equipment shall be such as to preclude any reasonably foreseeable risk in operation                     of the equipment. Particular attention shall be paid, where appropriate, to:                  
          -  closures and openings, 
          -  dangerous discharge of pressure relief blow-off, 
          -  devices to prevent physical access whilst pressure or a vacuum exists, 
          -  surface temperature taking into consideration the intended use, 
          -  decomposition of unstable fluids. 

In particular, pressure equipment fitted with an access door shall be equipped with an automatic or manual device enabling                     the user easily to ascertain that the opening will not present any risk. Furthermore, where the opening can be operated quickly,                     the pressure equipment shall be fitted with a device to prevent it being opened whenever the pressure or temperature of the                     fluid presents a risk.                  

##### 2.4.**Means of examination**U.K.

###### (a)Pressure equipment shall be designed and constructed so that all necessary examinations to ensure safety can be carried out;U.K.

###### (b)Means of determining the internal condition of the equipment shall be available, where it is necessary to ensure the continued                        safety of the equipment, such as access openings allowing physical access to the inside of the pressure equipment so that                        appropriate examinations can be carried out safely and ergonomically;U.K.

###### (c)Other means of ensuring the safe condition of the pressure equipment may be applied in any of the following situations:U.K.

          -  where it is too small for physical internal access, 
          -  where opening the pressure equipment would adversely affect the inside, 
          -  where the substance contained has been shown not to be harmful to the material from which the pressure equipment is made and                           no other internal degradation mechanisms are reasonably foreseeable.                         

##### 2.5.**Means of draining and venting**U.K.

Adequate means shall be provided for the draining and venting of pressure equipment where necessary:
          -  to avoid harmful effects such as water hammer, vacuum collapse, corrosion and uncontrolled chemical reactions. All stages                           of operation and testing, particularly pressure testing, shall be considered,                         
          -  to permit cleaning, inspection and maintenance in a safe manner. 

##### 2.6.**Corrosion or other chemical attack**U.K.

Where necessary, adequate allowance or protection against corrosion or other chemical attack shall be provided, taking due                     account of the intended and reasonably foreseeable use.                  

##### 2.7.**Wear**U.K.

Where severe conditions of erosion or abrasion may arise, adequate measures shall be taken to:
          -  minimise that effect by appropriate design, e.g. additional material thickness, or by the use of liners or cladding materials, 
          -  permit replacement of parts which are most affected, 
          -  draw attention, in the instructions referred to in point 3.4, to measures necessary for continued safe use. 

##### 2.8.**Assemblies**U.K.

Assemblies shall be so designed that:
          -  the components to be assembled together are suitable and reliable for their duty, 
          -  all the components are properly integrated and assembled in an appropriate manner. 

##### 2.9.**Provisions for filling and discharge**U.K.

Where appropriate, the pressure equipment shall be so designed and provided with accessories, or provision made for their                     fitting, as to ensure safe filling and discharge in particular with respect to risks such as:                  

on filling:
                -  overfilling or overpressurisation having regard in particular to the filling ratio and to vapour pressure at the reference                                    temperature,                                  
                -  instability of the pressure equipment; 

on discharge: the uncontrolled release of the pressurised fluid;

on filling or discharge: unsafe connection and disconnection.

##### 2.10.**Protection against exceeding the allowable limits of pressure equipment**U.K.

Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment shall be fitted                     with, or provision made for the fitting of, suitable protective devices, unless the equipment is intended to be protected                     by other protective devices within an assembly.                  

The suitable device or combination of such devices shall be determined on the basis of the particular characteristics of the                     equipment or assembly.                  

Suitable protective devices and combinations thereof comprise:

safety accessories as defined in point 4 of Article 2,

where appropriate, adequate monitoring devices such as indicators and/or alarms which enable adequate action to be taken either                              automatically or manually to keep the pressure equipment within the allowable limits.                           

##### 2.11.**Safety accessories**U.K.

###### 2.11.1.Safety accessories shall:U.K.

          -  be so designed and constructed as to be reliable and suitable for their intended duty and take into account the maintenance                           and testing requirements of the devices, where applicable,                         
          -  be independent of other functions, unless their safety function cannot be affected by such other functions, 
          -  comply with appropriate design principles in order to obtain suitable and reliable protection. These principles include, in                           particular, fail-safe modes, redundancy, diversity and self-diagnosis.                         

###### 2.11.2.*Pressure limiting devices*U.K.

These devices shall be so designed that the pressure will not permanently exceed the maximum allowable pressure PS; however                     a short duration pressure surge in keeping with the specifications laid down in point 7.3 is allowable, where appropriate.                  

###### 2.11.3.*Temperature monitoring devices*U.K.

These devices shall have an adequate response time on safety grounds, consistent with the measurement function.

##### 2.12.**External fire**U.K.

Where necessary, pressure equipment shall be so designed and, where appropriate, fitted with suitable accessories, or provision                     made for their fitting, to meet damage-limitation requirements in the event of external fire, having particular regard to                     its intended use.                  

#### 3.MANUFACTURINGU.K.

##### 3.1.**Manufacturing procedures**U.K.

The manufacturer shall ensure the competent execution of the provisions set out at the design stage by applying the appropriate                     techniques and relevant procedures, especially with a view to the aspects set out below.                  

###### 3.1.1.*Preparation of the component parts*U.K.

Preparation of the component parts (e.g. forming and chamfering) shall not give rise to defects or cracks or changes in the                     mechanical characteristics likely to be detrimental to the safety of the pressure equipment.                  

###### 3.1.2.*Permanent joining*U.K.

Permanent joints and adjacent zones shall be free of any surface or internal defects detrimental to the safety of the equipment.

The properties of permanent joints shall meet the minimum properties specified for the materials to be joined unless other                     relevant property values are specifically taken into account in the design calculations.                  

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components                     which are directly attached to them shall be carried out by suitably qualified personnel according to suitable operating procedures.                  

For pressure equipment in categories II, III and IV, operating procedures and personnel shall be approved by a competent third                     party which, at the manufacturer’s discretion, may be:                  
          -  a notified body, 
          -  a third-party organisation recognised by a Member State as provided for in Article 20. 

To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonised                     standards or equivalent examinations and tests or shall have them performed.                  

###### 3.1.3.*Non-destructive tests*U.K.

For pressure equipment, non-destructive tests of permanent joints shall be carried out by suitable qualified personnel. For                     pressure equipment in categories III and IV, the personnel shall be approved by a third-party organisation recognised by a                     Member State pursuant to Article 20.                  

###### 3.1.4.*Heat treatment*U.K.

Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the                     safety of the pressure equipment, suitable heat treatment shall be applied at the appropriate stage of manufacture.                  

###### 3.1.5.*Traceability*U.K.

Suitable procedures shall be established and maintained for identifying the material making up the components of the equipment                     which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured                     pressure equipment.                  

##### 3.2.**Final assessment**U.K.

Pressure equipment shall be subjected to final assessment as described below.

###### 3.2.1.*Final inspection*U.K.

Pressure equipment shall undergo a final inspection to assess visually and by examination of the accompanying documents compliance                     with the requirements of this Directive. Test carried out during manufacture may be taken into account. As far as is necessary                     on safety grounds, the final inspection shall be carried out internally and externally on every part of the equipment, where                     appropriate in the course of manufacture (e.g. where examination during the final inspection is no longer possible).                  

###### 3.2.2.*Proof test*U.K.

Final assessment of pressure equipment shall include a test for the pressure containment aspect, which will normally take                     the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in point 7.4.                  

For category I series-produced pressure equipment, this test may be performed on a statistical basis.

Where the hydrostatic pressure test is harmful or impractical, other tests of a recognised value may be carried out. For tests                     other than the hydrostatic pressure test, additional measures, such as non-destructive tests or other methods of equivalent                     validity, shall be applied before those tests are carried out.                  

###### 3.2.3.*Inspection of safety devices*U.K.

For assemblies, the final assessment shall also include a check of the safety devices intended to check full compliance with                     the requirements referred to in point 2.10.                  

##### 3.3.**Marking and labelling**U.K.

In addition to the CE marking referred to in Articles 18 and 19 and the information to be provided in accordance with Article                     6(6) and Article 8(3), the following information shall be provided:                  

for all pressure equipment:
                -  the year of manufacture, 
                -  identification of the pressure equipment according to its nature, such as type, series or batch identification and serial                                    number,                                  
                -  essential maximum/minimum allowable limits. 

depending on the type of pressure equipment, further information necessary for safe installation, operation or use and, where                              applicable, maintenance and periodic inspection such as:                           
                -  the volume V of the pressure equipment in L, 
                -  the nominal size for piping DN, 
                -  the test pressure PT applied in bar and date, 
                -  safety device set pressure in bar, 
                -  output of the pressure equipment in kW, 
                -  supply voltage in V (volts), 
                -  intended use, 
                -  filling ratio kg/L, 
                -  maximum filling mass in kg, 
                -  tare mass in kg, 
                -  the fluid group. 

where necessary, warnings fixed to the pressure equipment drawing attention to misuse which experience has shown might occur.

The information referred to in points (a), (b) and (c) shall be given on the pressure equipment or on a dataplate firmly attached                     to it, with the following exceptions:                  
          -  where applicable, appropriate documentation may be used to avoid repetitive marking of individual parts such as piping components,                           intended for the same assembly,                         
          -  where the pressure equipment is too small, e.g. accessories, this information may be given on a label attached to that pressure                           equipment,                         
          -  labelling or other adequate means may be used for the mass to be filled and the warnings referred to in point (c), provided                           it remains legible for the appropriate period of time.                         

##### 3.4.**Operating instructions**U.K.

###### (a)When pressure equipment is made available on the market, it shall be accompanied, as far as relevant, with instructions for                        the user, containing all the necessary safety information relating to:U.K.

          -  mounting including assembling of different pieces of pressure equipment, 
          -  putting into service, 
          -  use, 
          -  maintenance including checks by the user. 

###### (b)Instructions shall cover information affixed to the pressure equipment in accordance with point 3.3, with the exception of                        serial identification, and shall be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary                        for a full understanding of these instructions.U.K.

###### (c)If appropriate, these instructions shall also refer to risks arising from misuse in accordance with point 1.3 and particular                        features of the design in accordance with point 2.2.3.U.K.

#### 4.MATERIALSU.K.

Materials used for the manufacture of pressure equipment shall be suitable for such application during the scheduled lifetime                     unless replacement is foreseen.                  

Welding consumables and other joining materials need to fulfil only the relevant requirements of points 4.1, 4.2(a) and the                     first paragraph of point 4.3, in an appropriate way, both individually and in a joined structure.                  

##### 4.1.Materials for pressurised parts shall:U.K.

have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and                              in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials shall                              comply with the requirements of point 7.5. Moreover, due care should be exercised in particular in selecting materials in                              order to prevent brittle-type fracture where necessary; where for specific reasons brittle material has to be used appropriate                              measures shall be taken;                           

be sufficiently chemically resistant to the fluid contained in the pressure equipment; the chemical and physical properties                              necessary for operational safety shall not be significantly affected within the scheduled lifetime of the equipment;                           

not be significantly affected by ageing;

be suitable for the intended processing procedures;

be selected in order to avoid significant undesirable effects when the various materials are put together.

##### 4.2.The pressure equipment manufacturer shall:U.K.

define in an appropriate manner the values necessary for the design calculations referred to in point 2.2.3 and the essential                              characteristics of the materials and their treatment referred to in point 4.1;                           

provide in his technical documentation elements relating to compliance with the materials specifications of this Directive                              in one of the following forms:                           
                -  by using materials which comply with harmonised standards, 
                -  by using materials covered by a European approval of pressure equipment materials in accordance with Article 15, 
                -  by a particular material appraisal; 

for pressure equipment in categories III and IV, a specific assessment of the particular material appraisal shall be performed                              by the notified body in charge of conformity assessment procedures for the pressure equipment.                           

##### 4.3.The equipment manufacturer shall take appropriate measures to ensure that the material used conforms with the required specification.                        In particular, documentation prepared by the material manufacturer affirming compliance with a specification shall be obtained                        for all materials.U.K.

For the main pressure-bearing parts of equipment in categories II, III and IV, this shall take the form of a certificate of                     specific product control.                  

Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within                     the Union and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to                     certify conformity with the relevant requirements of this point.                  

### **SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS**U.K.

In addition to the applicable requirements of points 1 to 4, the following requirements apply to the pressure equipment covered                     by points 5 and 6.                  

#### 5.FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 4(1)U.K.

This pressure equipment includes:
          -  steam and hot-water generators as referred to in Article 4(1)(b), such as fired steam and hot-water boilers, superheaters                           and reheaters, waste-heat boilers, waste incineration boilers, electrode or immersion-type electrically heated boilers, pressure                           cookers, together with their accessories and where applicable their systems for treatment of feedwater and for fuel supply,                         
          -  process-heating equipment for other than steam and hot water generation falling under Article 4(1)(a), such as heaters for                           chemical and other similar processes and pressurised food-processing equipment.                         

This pressure equipment shall be calculated, designed and constructed so as to avoid or minimise risks of a significant loss                     of containment from overheating. In particular it shall be ensured, where applicable, that:                  

appropriate means of protection are provided to restrict operating parameters such as heat input, heat take-off and, where                              applicable, fluid level so as to avoid any risk of local and general overheating;                           

sampling points are provided where required to allow evaluation of the properties of the fluid so as to avoid risks related                              to deposits and/or corrosion;                           

adequate provisions are made to eliminate risks of damage from deposits;

means of safe removal of residual heat after shutdown are provided;

steps are taken to avoid a dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.

#### 6.PIPING AS REFERRED TO IN ARTICLE 4(1)(c)U.K.

Design and construction shall ensure:

that the risk of overstressing from inadmissible free movement or excessive forces being produced, e.g. on flanges, connections,                              bellows or hoses, is adequately controlled by means such as support, constraint, anchoring, alignment and pre-tension;                           

that where there is a possibility of condensation occurring inside pipes for gaseous fluids, means are provided for drainage                              and removal of deposits from low areas to avoid damage from water hammer or corrosion;                           

that due consideration is given to the potential damage from turbulence and formation of vortices; the relevant parts of point                              2.7 are applicable;                           

that due consideration is given to the risk of fatigue due to vibrations in pipes;

that, where fluids of Group 1 are contained in the piping, appropriate means are provided to isolate ‘take-off’ pipes the                              size of which represents a significant risk;                           

that the risk of inadvertent discharge is minimised; the take-off points shall be clearly marked on the permanent side, indicating                              the fluid contained;                           

that the position and route of underground piping is at least recorded in the technical documentation to facilitate safe maintenance,                              inspection or repair.                           

#### 7.SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENTU.K.

The following provisions apply as a general rule. However, where they are not applied, including in cases where materials                     are not specifically referred to and no harmonised standards are applied, the manufacturer shall demonstrate that appropriate                     measures have been taken to achieve an equivalent overall level of safety.                  

The provisions laid down in this section supplement the essential safety requirements of points 1 to 6 for the pressure equipment                     to which they apply.                  

##### 7.1.**Allowable stresses**U.K.

###### 7.1.1.*Symbols*U.K.

Re/t, yield limit, indicates the value at the calculation temperature of:                  
          -  the upper flow limit for a material presenting upper and lower flow limits, 
          -  the 1,0 % proof strength of austenitic steel and non-alloyed aluminium, 
          -  the 0,2 % proof strength in other cases. 

Rm/20 indicates the minimum value of the ultimate tensile strength at 20 °C.                  

Rm/t designates the ultimate tensile strength at the calculation temperature.                  

###### 7.1.2.The permissible general membrane stress for predominantly static loads and for temperatures outside the range in which creep                        is significant shall not exceed the smaller of the following values, according to the material used:U.K.

          -  in the case of ferritic steel including normalised (normalised rolled) steel and excluding fine-grained steel and specially                           heat-treated steel, 2/3 of Re/t and 5/12 of Rm/20,                         
          -  in the case of austenitic steel:              -  if its elongation after rupture exceeds 30 %, 2/3 of Re/t                                
            -  or, alternatively, and if its elongation after rupture exceeds 35 %, 5/6 of Re/t and 1/3 of Rm/t, 
          -  in the case of non-alloy or low-alloy cast steel, 10/19 of Re/t and 1/3 of Rm/20,                         
          -  in the case of aluminium, 2/3 of Re/t,                         
          -  in the case of aluminium alloys excluding precipitation hardening alloys 2/3 of Re/t and 5/12 of Rm/20.                         

##### 7.2.**Joint coefficients**U.K.

For welded joints, the joint coefficient shall not exceed the following values:
          -  for equipment subject to destructive and non-destructive tests which confirm that the whole series of joints show no significant                           defects: 1,                         
          -  for equipment subject to random non-destructive testing: 0,85, 
          -  for equipment not subject to non-destructive testing other than visual inspection: 0,7. 

If necessary, the type of stress and the mechanical and technological properties of the joint shall also be taken into account.

##### 7.3.**Pressure limiting devices, particularly for pressure vessels**U.K.

The momentary pressure surge referred to in point 2.11.2 shall be kept to 10 % of the maximum allowable pressure.

##### 7.4.**Hydrostatic test pressure**U.K.

For pressure vessels, the hydrostatic test pressure referred to in point 3.2.2 shall be no less than either of the following:
          -  that corresponding to the maximum loading to which the pressure equipment may be subject in service taking into account its                           maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1,25,                         
          -  the maximum allowable pressure multiplied by the coefficient 1,43, whichever is the greater. 

##### 7.5.**Material characteristics**U.K.

Unless other values are required in accordance with other criteria that shall be taken into account, a steel is considered                     as sufficiently ductile to satisfy point 4.1(a) if, in a tensile test carried out by a standard procedure, its elongation                     after rupture is no less than 14 % and its bending rupture energy measured on an ISO V test-piece is no less than 27 J, at                     a temperature not greater than 20 °C but not higher than the lowest scheduled operating temperature.                  

## ANNEX IIU.K.**CONFORMITY ASSESSMENT TABLES**

### 1.The references in the tables to categories of modules are the following:U.K.

### 2.The safety accessories defined in point 4 of Article 2, and referred to in Article 4(1)(d), are classified in category IV.                        However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category                        as the equipment they protect.U.K.

### 3.The pressure accessories defined in point 5 of Article 2, and referred to in Article 4(1)(d), are classified on the basis                        of:U.K.

          -  their maximum allowable pressure PS, 
          -  their volume V or their nominal size DN, as appropriate, 
          -  the group of fluids for which they are intended. 

The appropriate table for vessels or piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size are considered appropriate in the second indent of the first subparagraph, the                     pressure accessory shall be classified in the highest category.                  

### 4.The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.U.K.

                   

Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall                     be classified in category III.                  

                   

Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III.

                   

                   

Exceptionally, assemblies intended for generating warm water as referred to in the second subparagraph of Article 4(2), shall                     be subject either to an EU-type examination (Module B — design type) with respect to their conformity with the essential requirements                     referred to in points 2.10, 2.11, 3.4, 5(a) and 5(d) of Annex I, or to full quality assurance (Module H).                  

                   

Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least                     one of the category III modules.                  

                   

Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified                     in category III.                  

                   

Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis                     of Table 7 shall be classified in category III.                  

                   

                   

## ANNEX IIIU.K.**CONFORMITY ASSESSMENT PROCEDURES**

The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.

### 1.MODULE A: (INTERNAL PRODUCTION CONTROL)U.K.

#### 1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down                        in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the                        requirements of this Directive.U.K.

#### 2.**Technical documentation**U.K.

The manufacturer shall establish the technical documentation.

The technical documentation shall make it possible to assess the conformity of the pressure equipment to the relevant requirements,                     and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable                     requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment.                     The technical documentation shall, wherever applicable, contain at least the following elements:                  
          -  a general description of the pressure equipment, 
          -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
          -  descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure                           equipment,                         
          -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements of this                           Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                           technical documentation shall specify the parts which have been applied,                         
          -  results of design calculations made, examinations carried out, etc., 
          -  test reports. 

#### 3.**Manufacturing**U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance                     of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of                     this Directive.                  

#### 4.**CE marking and EU declaration of conformity**U.K.

##### 4.1.The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements                        of this Directive.U.K.

##### 4.2.The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together                        with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has                        been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn                        up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 5.**Authorised representative**U.K.

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under                     his responsibility, provided that they are specified in the mandate.                  

### 2.MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALSU.K.

#### 1.Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure                        whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and ensures and declares on his sole responsibility                        that the pressure equipment concerned satisfy the requirements of this Directive.U.K.

#### 2.**Technical documentation**U.K.

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity                     of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).                     The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the                     design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable,                     at least the following elements:                  
          -  a general description of the pressure equipment, 
          -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
          -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                           equipment,                         
          -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                           Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                           technical documentation shall specify the parts which have been applied,                         
          -  results of design calculations made, examinations carried out, etc., and 
          -  test reports. 

#### 3.**Manufacturing**U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance                     of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of                     this Directive that apply to it.                  

#### 4.**Final assessment and pressure equipment checks**U.K.

The manufacturer shall perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a                     notified body chosen by the manufacturer.                  

The notified body shall carry out product checks or have them carried out at random intervals determined by the body, in order                     to verify the quality of the internal checks of the pressure equipment, taking into account, inter alia, the technological                     complexity of the pressure equipment and the quantity of production.                  

During its unexpected visits, the notified body shall:
          -  establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I. 
          -  take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body                           assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part                           of the final assessment of the pressure equipment samples.                         

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure                     equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment.                  

Should one or more of the items of pressure equipment or assembly not conform, the notified body shall take appropriate measures.

The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during                     the manufacturing process.                  

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements                        of this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together                        with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has                        been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn                        up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 6.**Authorised representative**U.K.

The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under                     his responsibility, provided that they are specified in the mandate.                  

### 3.MODULE B: EU-TYPE EXAMINATIONU.K.

#### 3.1.***EU-Type examination – production type***U.K.

##### 1.EU-type examination — production type is the part of a conformity assessment procedure in which a notified body examines the                        technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets                        the requirements of this Directive.U.K.

##### 2.EU-type examination — production type shall consist of an assessment of the adequacy of the technical design of the pressure                        equipment through examination of the technical documentation and supporting evidence referred to in point 3, plus examination                        of a specimen, representative of the production envisaged, of the complete pressure equipment.U.K.

##### 3.The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment                           with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The                           technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design,                           manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least                           the following elements:                                      -  a general description of the pressure equipment, 
            -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
            -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                                 equipment,                               
            -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                                 Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                                 technical documentation shall specify the parts which have been applied,                               
            -  results of design calculations made, examinations carried out, etc., 
            -  test reports, 
            -  information concerning the tests provided for in manufacture, 
            -  information concerning the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I, 
          -  the specimens representative of the production envisaged. 

The specimen may cover several versions of the pressure equipment provided that the differences between the versions do not                     affect the level of safety.                  

The notified body may request further specimens if needed for carrying out the test programme;
          -  the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents                           that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence                           shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer applying                           other relevant technical specifications, or by another testing laboratory on his behalf and under his responsibility.                         

##### 4.The notified body shall:U.K.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure                              equipment and the manufacturing procedures.                           

In particular, the notified body shall:
                -  assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval                                    for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3                                    of Annex I,                                  
                -  approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved                                    in accordance with point 3.1.2 of Annex I,                                  
                -  verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are                                    qualified or approved in accordance with points 3.1.2 or 3.1.3 of Annex I.                                  

verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements                              which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the                              elements which have been designed using other relevant technical specifications without applying the relevant provisions of                              those standards.                           

carry out appropriate examinations and necessary tests to check whether when the manufacturer has chosen to apply the solutions                              in the relevant harmonised standards, these have been applied correctly.                           

carry out appropriate examinations and necessary tests to check whether, where the solutions in the relevant harmonised standards                              have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the                              corresponding essential safety requirements of this Directive.                           

agree with the manufacturer on a location where the examinations and tests will be carried out.

##### 5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and                        their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the                        content of that report, in full or in part, only with the agreement of the manufacturer.U.K.

##### 6.Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate                        – production type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable                        and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for                        its validity and the necessary data for identification of the approved type.U.K.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified                     body.                  

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment                     with the examined type to be evaluated and to allow for in-service control.                  

Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an                     EU-type examination certificate – production type and shall inform the applicant accordingly, giving detailed reasons for                     its refusal. Provision shall be made for an appeals procedure.                  

##### 7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate                        that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether                        such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.U.K.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination                     certificate – production type of all modifications to the approved type that may affect the conformity of the pressure equipment                     with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications                     shall require additional approval in the form of an addition to the original EU- type examination certificate – production                     type.                  

##### 8.Each notified body shall inform its notifying authority concerning the EU-type examination certificates – production type                        and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to                        its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.U.K.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates – production type                     and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning                     the certificates and/or additions thereto which it has issued.                  

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination                     certificates – production type and/or additions thereto. On request, the Commission and the Member States may obtain a copy                     of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall                     keep a copy of the EU-type examination certificate – production type, its annexes and additions, as well as the technical                     file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.                  

##### 9.The manufacturer shall keep a copy of the EU-type examination certificate – production type, its annexes and additions together                        with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has                        been placed on the market.U.K.

##### 10.The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set                        out in points 7 and 9, provided that they are specified in the mandate.U.K.

#### 3.2.***EU-Type examination – design type***U.K.

##### 1.EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical                        design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements                        of this Directive.U.K.

##### 2.The EU-type examination – design type shall consist of an assessment of the adequacy of the technical design of the pressure                        equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination                        of a specimen.U.K.

The experimental design method provided for in point 2.2.4 of Annex I shall not be used in the context of this module.

##### 3.The manufacturer shall lodge an application for EU-type examination — design type with a single notified body of his choice.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment                           with the applicable requirements of the Directive and shall include an adequate analysis and assessment of the risk(s). The                           technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design,                           manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least                           the following elements:                                      -  a general description of the pressure equipment, 
            -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
            -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                                 equipment,                               
            -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                                 Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                                 technical documentation shall specify the parts which have been applied,                               
            -  results of design calculations made, examinations carried out, etc., 
            -  information regarding the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I, 
          -  the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents                           that have been used, in particular where the relevant harmonised standards have not been applied in full. This supporting                           evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer                           or by another testing laboratory on his behalf and under his responsibility.                         

The application may cover several versions of the pressure equipment provided that the differences between the versions do                     not affect the level of safety.                  

##### 4.The notified body shall:U.K.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.

In particular, the notified body shall:
                -  assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval                                    for pressure equipment materials,                                  
                -  approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved                                    in accordance with point 3.1.2 of Annex I.                                  

carry out appropriate examinations to check whether where the manufacturer has chosen to apply the solutions in the relevant                              harmonised standards these have been applied correctly.                           

carry out appropriate examinations to check whether, where the solutions in the relevant harmonised standards have not been                              applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Directive.                           

##### 5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and                        their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release                        the content of that report, in full or in part, only with the agreement of the manufacturer.U.K.

##### 6.Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate                        — design type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable                        and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for                        its validity and the necessary data for identification of the approved design.U.K.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified                     body.                  

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment                     with the examined design to be evaluated and to allow for in-service control.                  

Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an                     EU-type examination certificate — design type and shall inform the applicant accordingly, giving detailed reasons for its                     refusal.                  

##### 7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate                        that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether                        such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.U.K.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination                     certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment                     with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications                     shall require additional approval in the form of an addition to the original EU-type examination certificate — design type.                  

##### 8.Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or                        any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying                        authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.U.K.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or                     any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the                     certificates and/or additions thereto which it has issued.                  

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination                     certificates — design type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of                     the technical documentation and the results of the examinations carried out by the notified body. The notified body shall                     keep a copy of the EU-type examination certificate — design type, its annexes and additions, as well as the technical file                     including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.                  

##### 9.The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together                        with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has                        been placed on the market.U.K.

##### 10.The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set                        out in points 7 and 9, provided that they are specified in the mandate.U.K.

### 4.MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALSU.K.

#### 1.Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals is the                        part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4,                        and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described                        in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity                     of the manufactured pressure equipment with the type described in the EU-type examination certificate and with the requirements                     of this Directive that apply to them.                  

#### 3.**Final assessment and pressure equipment checks**U.K.

A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined                     by the body, in order to verify the quality of the final assessment and of the internal checks on the pressure equipment,                     taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.                  

The notified body shall establish that the manufacturer actually performs final assessment in accordance with point 3.2 of                     Annex I.                  

An adequate sample of the final pressure equipment, taken on site by the notified body before the placing on the market, shall                     be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests                     applying other technical specifications, shall be carried out to check the conformity of the pressure equipment with the relevant                     requirements of this Directive.                  

The notified body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have                     performed, all or part of final assessment on the pressure equipment samples.                  

Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure                     equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment.                  

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body,                     affix the notified body’s identification number during the manufacturing process.                  

#### 4.**CE marking and EU declaration of conformity**U.K.

##### 4.1.The manufacturer shall affix the CE marking to each individual pressure equipment or assembly that is in conformity with the                        type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.U.K.

##### 4.2.The manufacturer shall draw up a written EU declaration of conformity for a pressure equipment model and keep it at the disposal                        of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of                        conformity shall identify the pressure equipment model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 5.**Authorised representative**U.K.

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under                     his responsibility, provided that they are specified in the mandate.                  

### 5.MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESSU.K.

#### 1.Conformity to type based on quality assurance of the production process is that part of a conformity assessment procedure                        whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility                        that the pressure equipment or assembly concerned is in conformity with the type described in the EU-type examination certificate                        and satisfies the requirements of this Directive that apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure                     equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.                  

#### 3.**Quality system**U.K.

##### 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  all relevant information on the pressure equipment type envisaged, 
          -  the documentation concerning the quality system, 
          -  the technical documentation of the approved type and a copy of the EU-type examination certificate. 

##### 3.2.The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU-type examination                        certificate and comply with the requirements of this Directive that apply to it.U.K.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the                           quality of the pressure equipment,                         
          -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will                           be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of                           Annex I,                         
          -  the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they                           will be carried out,                         
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the                           non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc., and                         
          -  the means of monitoring the achievement of the required quality and the effective operation of the quality system. 

##### 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        3.2.U.K.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the                     corresponding specifications of the relevant harmonised standard.                  

In addition to experience in quality management systems, the auditing team shall have at least one member with experience                     of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable                     requirements of this Directive. The audit shall include an inspection visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer’s                     ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to                     ensuring compliance of the product with those requirements.                  

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned                     assessment decision.                  

##### 3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 3.2 or whether a reassessment is necessary.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

#### 4.**Surveillance under the responsibility of the notified body**U.K.

##### 4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and                        storage sites and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned,                           etc.                         

##### 4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment                        is carried out every three years.U.K.

##### 4.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the                        frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular,                        the following factors shall be considered in the visit control system:U.K.

          -  the category of the pressure equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective actions, 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits the notified body may, if necessary, carry out product tests or have them carried out in order to verify                     that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and,                     if tests have been carried out, with a test report.                  

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the                        latter’s identification number to each individual pressure equipment that is in conformity with the type described in the                        EU-type examination certificate and satisfies the applicable requirements of this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the pressure equipment model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 6.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the documentation referred to point 3.1, 
          -  the change referred to in point 3.5, as approved, 
          -  the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4. 

#### 7.Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall,                        periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended                        or otherwise restricted.U.K.

Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended,                     withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.                  

#### 8.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his                     behalf and under his responsibility, provided that they are specified in the mandate.                  

### 6.MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESSU.K.

#### 1.Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations                        laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned                        satisfy the requirements of this Directive that apply to it.U.K.

#### 2.**Technical documentation**U.K.

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity                     of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s).                     The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the                     design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least                     the following elements:                  
          -  a general description of the pressure equipment, 
          -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
          -  descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure                           equipment,                         
          -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                           Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                           technical documentation shall specify the parts which have been applied,                         
          -  results of design calculations made, examinations carried out, etc., and 
          -  test reports. 

#### 3.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years                        after the pressure equipment has been placed on the market.U.K.

#### 4.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure                     equipment concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.                  

#### 5.**Quality system**U.K.

##### 5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  all relevant information on the pressure equipment type envisaged, 
          -  the documentation concerning the quality system, 
          -  the technical documentation referred to in point 2. 

##### 5.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to                        it.U.K.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the                           quality of the pressure equipment,                         
          -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that                           will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2                           of Annex I,                         
          -  the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they                           will be carried out,                         
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance                           with point 3.1.2 of Annex I, etc.,                         
          -  the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 

##### 5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        5.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the                        corresponding requirements referred to in point 5.2.U.K.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience                     of evaluation in the pressure equipment technology concerned, and the knowledge of the applicable requirements of this Directive.                     The audit shall include an assessment visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability                     to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring                     compliance of the pressure equipment with those requirements.                  

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned                     assessment decision.                  

##### 5.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 5.2 or whether a reassessment is necessary.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

#### 6.**Surveillance under the responsibility of the notified body**U.K.

##### 6.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 6.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and                        storage sites and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the technical documentation referred to in point 2, 
          -  the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned,                           etc.                         

##### 6.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment                        is carried out every three years.U.K.

##### 6.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the                        frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular,                        the following factors shall be considered in the visit control system:U.K.

          -  the category of the pressure equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective action(s), 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify                     that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and,                     if tests have been carried out, with a test report.                  

#### 7.**CE marking and EU declaration of conformity**U.K.

##### 7.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the                        latter’s identification number to each individual pressure equipment that satisfies the applicable requirements of this Directive.U.K.

##### 7.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the product model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 8.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the documentation referred to in point 5.1, 
          -  the change referred to in point 5.5, 
          -  the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4. 

#### 9.Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall periodically,                        or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise                        restricted.U.K.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, or                     withdrawn, and upon request, of quality system approvals which it has issued.                  

#### 10.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on                     his behalf and under his responsibility, provided that they are specified in the mandate.                  

### 7.MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCEU.K.

#### 1.Conformity to type based on pressure equipment quality assurance is that part of a conformity assessment procedure whereby                        the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility                        that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and                        satisfies the requirements of this Directive that apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment                     concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.                  

#### 3.**Quality system**U.K.

##### 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  all relevant information on the pressure equipment type envisaged, 
          -  the documentation concerning the quality system, 
          -  the technical documentation of the approved type and a copy of the EU-type examination certificate. 

##### 3.2.The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate                        and with the applicable requirements of this Directive.U.K.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product                           quality,                         
          -  the examinations and tests that will be carried out after manufacture, 
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the                           non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I,                         
          -  the means of monitoring the effective operation of the quality system. 

##### 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with                        the corresponding specifications of the relevant harmonised standard.U.K.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience                     of evaluation in the relevant pressure equipment field and pressure equipment technology concerned and knowledge of the applicable                     requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, in order to verify the                     manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations                     with a view to ensuring compliance of the pressure equipment with those requirements.                  

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned                     assessment decision.                  

##### 3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 3.2 or whether a reassessment is necessary.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

#### 4.**Surveillance under the responsibility of the notified body**U.K.

##### 4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and                        storage sites and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the technical documentation, 
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of                           the personnel concerned, etc.                         

##### 4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment                        is carried out every three years.U.K.

##### 4.4.In addition the notified body may pay unexpected visits to the manufacturer.U.K.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system                     operated by the notified body. In particular, the following factors shall be considered in the visit control system:                  
          -  the category of the pressure equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective actions, 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify                     that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and,                     if tests have been carried out, with a test report.                  

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the                        latter’s identification number to each individual pressure equipment that is in conformity with the type described in the                        EU-type examination certificate and satisfies the applicable requirements of this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the product model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 6.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the documentation referred to in point 3.1, 
          -  the change referred to in point 3.5, as approved, 
          -  the decisions and reports from the notified body which are referred to in points 3.3, 3.5, 4.3 and 4.4. 

#### 7.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall, periodically                        or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise                        restricted.U.K.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn,                     and, upon request, of quality system approvals which it has issued.                  

#### 8.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his                     behalf and under his responsibility, provided that they are specified in the mandate.                  

### 8.MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND TESTINGU.K.

#### 1.Quality assurance of final pressure equipment inspection and testing is the conformity assessment procedure whereby the manufacturer                        fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure                        equipment concerned satisfy the requirements of this Directive that apply to it.U.K.

#### 2.**Technical documentation**U.K.

The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess                     the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment                     of the risk(s) The technical documentation shall specify the applicable requirements and cover, as far as relevant for the                     assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable,                     contain at least the following elements:                  
          -  a general description of the pressure equipment, 
          -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
          -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                           equipment,                         
          -  a list of the harmonised standards, the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                           Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                           technical documentation shall specify the parts which have been applied,                         
          -  results of design calculations made, examinations carried out, etc., and 
          -  test reports. 

#### 3.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years                        after the pressure equipment has been placed on the market.U.K.

#### 4.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment                     as specified in point 5 and shall be subject to surveillance as specified in point 6.                  

#### 5.**Quality system**U.K.

##### 5.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  all relevant information on the pressure equipment type envisaged, 
          -  the documentation concerning the quality system, and 
          -  the technical documentation referred to in point 2. 

##### 5.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to                        it.U.K.

Under the quality system, each item of pressure equipment shall be examined and appropriate tests as set out in the relevant                     standard(s) referred to in Article 12, or equivalent tests, and particularly final assessment as referred to in point 3.2                     of Annex I, shall be carried out in order to ensure its conformity with the requirements of this Directive which apply to                     it.                  

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the                           quality of the pressure equipment,                         
          -  the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I, 
          -  the examinations and tests that will be carried out after manufacture, 
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance                           with point 3.1.2 of Annex I,                         
          -  the means of monitoring the effective operation of the quality system. 

##### 5.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        5.2.U.K.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the                     corresponding specifications of the relevant harmonised standard.                  

In addition to experience in quality management systems, the auditing team shall have at least one member with experience                     of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable                     requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability                     to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring                     compliance of the pressure equipment with those requirements.                  

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned                     assessment decision.                  

##### 5.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 5.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 5.2 or whether a reassessment is required.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

#### 6.**Surveillance under the responsibility of the notified body**U.K.

##### 6.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 6.2.The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and                        storage sites and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the technical documentation referred to in point 2, 
          -  the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned,                           etc.                         

##### 6.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment                        is carried out every three years.U.K.

##### 6.4.In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the                        frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular,                        the following factors shall be considered in the visit control system:U.K.

          -  the category of the equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective action(s), 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify                     that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and,                     if tests have been carried out, with a test report.                  

#### 7.**CE marking and EU declaration of conformity**U.K.

##### 7.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the                        latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of                        this Directive.U.K.

##### 7.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the pressure equipment model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 8.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the documentation referred to in point 5.1, 
          -  the change referred to in point 5.5, as approved, 
          -  the decisions and reports of the notified body referred to in points 5.3, 5.5, 6.3 and 6.4. 

#### 9.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn and shall periodically                        or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise                        restricted.U.K.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn,                     and, upon request, of quality system approvals which it has issued.                  

#### 10.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on                     his behalf and under his responsibility, provided that they are specified in the mandate.                  

### 9.MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATIONU.K.

#### 1.Conformity to type based on pressure equipment verification is the part of a conformity assessment procedure whereby the manufacturer                        fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure                        equipment concerned, which has been subject to the provisions of point 3, is in conformity with the type described in the                        EU-type examination certificate and satisfies the requirements of this Directive which apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity                     of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements                     of this Directive which apply to them.                  

#### 3.**Verification**U.K.

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity                     of the pressure equipment with the approved type described in the EU-type examination certificate and with the appropriate                     requirements of this Directive.                  

The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried                     out by examination and testing of every product as specified in point 4.                  

#### 4.**Verification of conformity by examination and testing of every item of pressure equipment**U.K.

##### 4.1.All pressure equipment shall be individually examined and appropriate tests set out in the relevant harmonised standard(s)                        or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the EU-type                        examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard,                        the notified body concerned shall decide on the appropriate tests to be carried out.U.K.

In particular, the notified body shall:
          -  verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved                           in accordance with points 3.1.2 and 3.1.3 of Annex I,                         
          -  verify the certificate issued by the materials manufacturer in accordance with point 4.3 of Annex I, 
          -  carry out or have carried out the final inspection and proof test referred to in point 3.2 of Annex I and examine the safety                           devices, if applicable.                         

##### 4.2.The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall                        affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.U.K.

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

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the                        latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type                        described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities, for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the pressure equipment model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified                     body’s identification number to the pressure equipment.                  

#### 6.If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number                        to the pressure equipment during the manufacturing process.U.K.

#### 7.**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 point 2.                  

### 10.MODULE G: CONFORMITY BASED ON UNIT VERIFICATIONU.K.

#### 1.Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations                        laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned,                        which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to                        it.U.K.

#### 2.**Technical documentation**U.K.

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point                     4.                  

The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements                     and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable                     requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment.                  

The technical documentation shall, wherever applicable, contain at least the following elements:
          -  a general description of the pressure equipment, 
          -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
          -  descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure                           equipment,                         
          -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                           Directive where those harmonised standards, have not been applied. In the event of partly applied harmonised standards, the                           technical documentation shall specify the parts which have been applied,                         
          -  results of design calculations made, examinations carried out, etc., 
          -  test reports, 
          -  appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals                           of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.                         

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years                     after the pressure equipment has been placed on the market.                  

#### 3.**Manufacturing**U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity                     of the manufactured pressure equipment with the applicable requirements of this Directive.                  

#### 4.**Verification**U.K.

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised                     standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of                     this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide                     on the appropriate tests to be carried out applying other technical specifications.                  

In particular the notified body shall:
          -  examine the technical documentation with respect to the design and the manufacturing procedures, 
          -  assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval                           for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3                           of Annex I,                         
          -  approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with                           point 3.1.2 of Annex I,                         
          -  verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I, 
          -  carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to                           in point 3.2.2 of Annex I, and examine the safety devices, if applicable.                         

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix                     its identification number to the approved pressure equipment, or have it affixed under its responsibility. The manufacturer                     shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment                     has been placed on the market.                  

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the                        latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities                        for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the                        pressure equipment for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 6.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf                     and under his responsibility, provided that they are specified in the mandate.                  

### 11.MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCEU.K.

#### 1.Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations                        laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfies                        the requirements of this Directive that apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of                     the pressure equipment as specified in point 3 and shall be subject to surveillance as specified in point 4.                  

#### 3.**Quality system**U.K.

##### 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation                           shall, wherever applicable, contain at least the following elements:                                      -  a general description of the pressure equipment, 
            -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
            -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                                 equipment,                               
            -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                                 Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                                 technical documentation shall specify the parts which have been applied,                               
            -  results of design calculations made, examinations carried out, etc., 
            -  test reports, 
          -  the documentation concerning the quality system, and 
          -  a written declaration that the same application has not been lodged with any other notified body. 

##### 3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to                        it.U.K.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design                           and product quality,                         
          -  the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards                           will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that                           apply to the pressure equipment will be met,                         
          -  the design control and design verification techniques, processes and systematic actions that will be used when designing the                           pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point                           4 of Annex I,                         
          -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will                           be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex                           I,                         
          -  the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will                           be carried out,                         
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the                           non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,                         
          -  the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation                           of the quality system.                         

##### 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with                        the corresponding specifications of the relevant harmonised standard.U.K.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor                     in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit                     shall include an assessment visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s                     ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view                     to ensuring compliance of the pressure equipment with those requirements.                  

The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions                     of the audit and the reasoned assessment decision.                  

##### 3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 3.2 or whether a reassessment is necessary.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

#### 4.**Surveillance under the responsibility of the notified body**U.K.

##### 4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing                        and storage sites and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests,                           etc.,                         
          -  the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data,                           calibration data, qualification reports on the personnel concerned, etc.                         

##### 4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment                        is carried out every three years.U.K.

##### 4.4.In addition, the notified body may pay unexpected visits to the manufacturer.U.K.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system                     operated by the notified body. In particular, the following factors shall be considered in the visit control system:                  
          -  the category of the equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective action(s), 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check                     the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been                     carried out, with a test report.                  

#### 5.**CE marking and EU declaration of conformity**U.K.

##### 5.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the                        latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of                        this Directive.U.K.

##### 5.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the pressure equipment model for which it has been drawn up.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 6.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the technical documentation referred to in point 3.1, 
          -  the documentation concerning the quality system referred to in point 3.1, 
          -  the change referred to point 3.4, as approved, 
          -  the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4. 

#### 7.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically                        or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise                        restricted.U.K.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn,                     and, upon request, of quality system approvals which it has issued.                  

#### 8.**Authorised representative**U.K.

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his                     behalf and under his responsibility, provided that they are specified in the mandate.                  

### 12.MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATIONU.K.

#### 1.Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the                        conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures                        and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that                        apply to it.U.K.

#### 2.**Manufacturing**U.K.

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing                     of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy                     of the technical design of the pressure equipment shall have been examined in accordance with point 4.                  

#### 3.**Quality system**U.K.

##### 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for                        the pressure equipment concerned.U.K.

The application shall include:
          -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                           address as well,                         
          -  the technical documentation for one model of each type of pressure equipment intended to be manufactured. The technical documentation                           shall, wherever applicable, contain at least the following elements:                                      -  a general description of the pressure equipment, 
            -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
            -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                                 equipment,                               
            -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                                 Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                                 technical documentation shall specify the parts which have been applied,                               
            -  results of design calculations made, examinations carried out, etc., 
            -  test reports, 
          -  the documentation concerning the quality system, 
          -  a written declaration that the same application has not been lodged with any other notified body. 

##### 3.2.The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to                        it.U.K.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly                     manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent                     interpretation of the quality programmes, plans, manuals and records.                  

It shall, in particular, contain an adequate description of:
          -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design                           and product quality,                         
          -  the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will                           not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that                           apply to the pressure equipment will be met,                         
          -  the design control and design verification techniques, processes and systematic actions that will be used when designing the                           pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance                           with point 4 of Annex I,                         
          -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will                           be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex                           I,                         
          -  the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they                           will be carried out,                         
          -  the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or                           approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the                           non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,                         
          -  the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation                           of the quality system.                         

##### 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point                        3.2.U.K.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the                     corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems,                     the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure                     equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an                     assessment visit to the manufacturer’s premises.                  

The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s                     ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view                     to ensuring compliance of the pressure equipment with those requirements.                  

The manufacturer or his authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

##### 3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it                        so that it remains adequate and efficient.U.K.

##### 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the                        quality system.U.K.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy                     the requirements referred to in point 3.2 or whether a re-assessment is necessary.                  

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the                     reasoned assessment decision.                  

##### 3.6.Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically                        or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise                        restricted.U.K.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn,                     and, upon request, of quality system approvals which it has issued.                  

#### 4.**Design examination**U.K.

##### 4.1.The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by                        a previous design examination with the notified body referred to in point 3.1.U.K.

##### 4.2.The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and                        to assess the conformity with the requirements of this Directive that apply to it. It shall include:U.K.

          -  the name and address of the manufacturer, 
          -  a written declaration that the same application has not been lodged with any other notified body, 
          -  the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with                           the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation                           shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the                           pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:                                      -  a general description of the pressure equipment, 
            -  conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc., 
            -  descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure                                 equipment,                               
            -  a list of the harmonised standards the references of which have been published in the *Official Journal of the European Union*, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this                                 Directive, where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the                                 technical documentation shall specify the parts which have been applied,                               
            -  results of design calculations made, examinations carried out, etc., and 
            -  test reports, 
          -  the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that                           have been used, in particular where the relevant harmonised standards have not been applied in full, and shall include, where                           necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory                           on his behalf and under his responsibility.                         

##### 4.3.The notified body shall examine the application, and where the design meets the requirements of this Directive that apply                        to the pressure equipment it shall issue an EU design examination certificate to the manufacturer. The certificate shall give                        the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and                        the data necessary for identification of the approved design. The certificate may have one or more annexes attached.U.K.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with                     the examined design to be evaluated, and to allow for in-service control, where applicable.                  

Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue a                     design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.                  

##### 4.4.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate                        that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether                        such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.U.K.

The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification                     to the approved design that may affect the conformity with the essential safety requirements of this Directive or the conditions                     for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued                     the EU design examination certificate — in the form of an addition to the original EU design examination certificate.                  

##### 4.5.Each notified body shall inform its notifying authorities of the EU design examination certificates and/or any additions thereto                        which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the                        list of certificates and/or any additions thereto refused, suspended or otherwise restricted.U.K.

Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto                     which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions                     thereto which it has issued.                  

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination                     certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical                     documentation and of the results of the examinations carried out by the notified body.                  

The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical                     file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.                  

##### 4.6.The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical                        documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the                        market.U.K.

#### 5.**Surveillance under the responsibility of the notified body**U.K.

##### 5.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved                        quality system.U.K.

##### 5.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing                        and storage sites, and shall provide it with all necessary information, in particular:U.K.

          -  the quality system documentation, 
          -  the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests,                           etc.,                         
          -  the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data,                           calibration data, qualification reports on the personnel concerned, etc.                         

##### 5.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system                        and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment                        is carried out every three years.U.K.

##### 5.4.In addition, the notified body may pay unexpected visits to the manufacturer.U.K.

The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system                     operated by the notified body. In particular, the following factors must be considered in the visit control system:                  
          -  the category of the equipment, 
          -  the results of previous surveillance visits, 
          -  the need to follow up corrective action(s), 
          -  special conditions linked to the approval of the system, where applicable, 
          -  significant changes in manufacturing organisation, policy or techniques. 

During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check                     the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been                     carried out, with a test report.                  

##### 5.5.Special surveillance of the final assessmentU.K.

Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits                     by the notified body. In the course of such visits, the notified body shall conduct examinations on the pressure equipment.                  

It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

#### 6.**CE marking and EU declaration of conformity**U.K.

##### 6.1.The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the                        latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of                        this Directive.U.K.

##### 6.2.The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the                        disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration                        of conformity shall identify the pressure equipment model for which it has been drawn up and shall mention the number of the                        design examination certificate.U.K.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

#### 7.The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the                        disposal of the national authorities:U.K.

          -  the documentation concerning the quality system referred to in point 3.1, 
          -  the change referred to in point 3.5, as approved, 
          -  the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4. 

#### 8.**Authorised representative**U.K.

The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations                     set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified                     in the mandate.                  

## ANNEX IVU.K.**EU DECLARATION OF CONFORMITY (No XXXX)** (24) 

### 1.Pressure equipment or assembly (product, type, batch or serial number):U.K.

### 2.Name and address of the manufacturer and, where applicable, his authorised representative:U.K.

### 3.This declaration of conformity is issued under the sole responsibility of the manufacturer.U.K.

### 4.Object of the declaration (identification of pressure equipment or assembly allowing traceability; it may, where necessary                        for the identification of the pressure equipment or assembly, include an image):U.K.

          -  description of the pressure equipment or assembly, 
          -  conformity assessment procedure followed, 
          -  in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment                           procedures followed,                         

### 5.The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:U.K.

### 6.References to the relevant harmonised standards used or references to the other technical specifications in relation to which                        conformity is declared:U.K.

### 7.Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and the number                        of the certificate issued, and a reference to the EU-type examination certificate – production type, EU-type examination certificate                        – design type, EU design examination certificate or certificate of conformity.U.K.

### 8.Additional information:U.K.

Signed for and on behalf of:
          -  (place and date of issue): 
          -  (name, function) (signature): 
          -  (where appropriate, particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or                           his authorised representative)                         

## ANNEX VU.K.

### **PART A**

**Repealed Directive with list of the successive amendments thereto**

(referred to in Article 50)

### **PART B**

**Time-limit for transposition into national law and date of application**

(referred to in Article 49)

## ANNEX VIU.K.

### **CORRELATION TABLE**

U.K.

# STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011                           are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex                           I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees                           thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.                        

1

OJ C 67, 6.3.2014, p. 101.                           

2

Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council                              of 13 May 2014.                           

3

Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member                              States concerning pressure equipment (OJ L 181, 9.7.1997, p. 1).                           

4

See Annex V, Part A.

5

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for                              accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).                           

6

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing                              of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).                           

7

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous                              goods (OJ L 260, 30.9.2008, p. 13).                           

8

Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and                              repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).                           

9

Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating                              to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).                           

10

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling                              and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation                              (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).                           

11

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,                              amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,                              2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC                              and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).                           

12

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general                              principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).                           

13

Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of                              the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).                           

14

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers                              (OJ L 147, 9.6.1975, p. 40).                           

15

Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval                              of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework                              Directive) (OJ L 263, 9.10.2007, p. 1).                           

16

Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance                              of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).                           

17

Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance                              of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).                           

18

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC                              (OJ L 157, 9.6.2006, p. 24).                           

19

Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of                              the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).                           

20

Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of                              the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage                              limits (OJ L 96, 29.3.2014, p. 357).                           

21

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).                           

22

Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous                              fuels (OJ L 330, 16.12.2009, p. 10).                           

23

Directive 2014/34/EU of the European Parliament and the Council of 26 February 2014 on the harmonisation of the laws of the                              Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).                           

24

It is optional for the manufacturer to assign a number to the declaration of conformity.