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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

By way of derogation from paragraphs 1 to 6 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 to 6 of this Article have not been applied and the use of which is in the interests of experimentation.

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.

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.

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.

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

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.

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.

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).

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.

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

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.

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

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

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

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

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

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.

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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

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.

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.

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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

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.

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.

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

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

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

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.

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.

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

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

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.

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.

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

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.

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.

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 19 July 2016.

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

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.

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.

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.