EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 28.6.2013  
COM(2013) 471 final 
2013/0221 (COD) 
  
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the  harmonisation of the la ws of the Member States  re lating to making available on 
the market of pressure equipment 
(Recast) 
 
(Text with EEA relevance) 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
General context, reasons for and objectives of this proposal  
This proposal intends to align Directive 97/ 23/EC on pressure equipment to the ‘goods 
package’ adopted in 20 08 and in particular to  Decision No 768/2008/EC  establishing a 
common framework for the marketing of products. It also intends to a lign Directive 97/23/EC 
to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling a nd packaging of substances and mixtures1. 
a) Alignment to Decision No 768/2008/EC:  Union (EU) harmonisation legislation ensuring th e free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level of protection and provides econom ic operators with the means to demonstrate conformity, 
thus ensuring free movement through trust in the products.  
Directive 97/23/EC is an example of that Un ion harmonisation legisla tion, ensuring the free 
movement of pressure equipment. It sets ou t essential safety requirements that pressure 
equipment and assemblies must comply with in order to be made ava ilable on the EU market. 
Manufacturers must demonstrate that pres sure equipment has been designed and 
manufactured in compliance with the essential safety requiremen ts and affix the CE marking.  
Experience with the implementation of Uni on harmonisation legislation has shown – on a 
cross-sector scale - certain weaknesses and inconsistencies in the implementation and 
enforcement of this legislation, leading to: 
– the presence of non-compliant or da ngerous products on the market and 
consequently a certain lack of trust in CE marking; 
– competitive disadvantages for economic operators complying with the legislation 
as opposed to those circumventing the rules; 
– unequal treatment in the case of non-compliant products and distortion of 
competition amongst economic operators due to different enforcement practices; 
– differing practices in the designation of conformity assessment bodies by national 
authorities; 
– problems with the quality of  certain notified bodies. 
Furthermore the regulatory environment has beco me more and more complex, as frequently 
several pieces of legisla tion apply simultaneously to one and the same product. 
Inconsistencies in these piece s of legislation make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
                                                
 
1 OJ L 353, 31.12.2008, p.1. EN 3   EN To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, th e ‘New Legislative Framework’ was adopted in 2008 as part of 
the goods package. Its objective is to strengthen and comple te the existing rules and to 
improve practical aspects of their applica tion and enforcement. The New Legislative 
Framework (NLF) consists of two complement ary instruments, Regulation (EC) No 765/2008 
on accreditation and market surveillance an d Decision No 768/2008/EC establishing a 
common framework for the marketing of products (hereinafter NLF Decision). 
The NLF Regulation has introduced rules on accreditation (a tool for the evaluation of 
competence of conformity assessment bodies) and requirements for the organisation and 
performance of market surveillance and contro ls of products from th ird countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc.). These common provisions have been reinforced to ensure that the directives can be applied and enforced more ef fectively in practice. New elements, such as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market.  
The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely interlinked. The NLF Decision contains  the corresponding obligations for economic 
operators and notified bodies allowing market  surveillance authoriti es and authorities 
responsible for notified bodies to properly pe rform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation.  
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that all economic sect ors subject to Union ha rmonisation legislation 
benefit from the improvements of the NLF, th e provisions of the NLF Decision need to be 
integrated into the ex isting product legislation. 
The Commission has already proposed the alignm ent of nine other Directives to the NLF 
Decision within an NLF implementati on package adopted on 21 November 2011
2.  
                                                 
2 The ‘New Legislative Framework (NLF) Alignment P ackage’ of 21 November 2011 consisted of the 
following nine legislative proposals : Proposal for a Directive of the European Parliament and of the 
Council on the harmonisation of the laws of the Member  States relating to the making available on the 
market of pyrotechnic articles (COM(2011) 764 final); Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to 
electromagnetic compatibility (COM(2011) 765 final); Proposal for a Directive of the European 
Parliament and of the Council on the harmonisation of the laws of the Member States relating to making available on the market of non-automatic weighing instruments (COM(2011) 766 final); Proposal for a 
Directive of the European Parliament and of the Council on the harmonisation of the laws of the 
Member States relating to making available on the market of simple pressure vessels (COM(2011) 768 
final); Proposal for a Directive of the European Parliament and of the Council on the harmonisation of 
the laws of the Member States relating to making available on the market of measuring instruments 
(COM(2011) 769 final); Proposal for a Directive of the European Parliament and of the Council on the 
harmonisation of the laws of the Member States relating to making available on the market of lifts and 
safety components for lifts (COM(2011) 770 final); Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making 
available on the market and supervisions of explosives for civil uses (COM(2011) 771 final); Proposal 
for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the EN 4   EN In view of ensuring consistency across Uni on harmonisation legislation for industrial 
products, it is necessary to ali gn Directive 97/23/EC to the provisions of the NLF Decision. 
The proposal also takes into account the proposal of the Co mmission of 13 February 2013 for 
a Regulation on market surveillance of products3. 
b) Alignment to Regulation (EC) No 1272/2008:  Regulation (EC) No 1272/2008 (her einafter CLP Regulation), implements within the Union 
the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) that has 
been adopted at the international level, within the structure of the United Nations. 
Directive 97/23/EC provides, in Article 9, fo r a classification of pressure equipment in 
categories, according to the ascending level of ri sk due to pressure. While the classification of 
pressure equipment under the Di rective is mainly based on the total energetic content 
(pressure and volume of the pressure equipment) , it is also influenced by the classification 
(dangerous or not) of the fluid it contains. 
The classification of pressure equipment into categories is directly related to the conformity 
assessment procedure applied in order to verify the conformity of the pressure equipment to 
the essential requirements of Directive 97/23/EC . In particular, the conformity assessment 
procedure to be applied is determined by the ca tegory, as defined in Article 9, in which the 
equipment is classified. 
The classification of the fluids contained in the pressure equipment for the purposes of the 
classification of the pressure equipment in vi ew of its conformity assessment, is based on 
Council Directive 67/548/EEC of 27 June 1967 on the approximati on of the laws, regulations 
and administrative provisions relating to th e classification, packaging and labelling of 
dangerous substances
4. 
According to Article 9 of Directive 97/23/EC, the ‘fluids’ are divide d into two groups. Group 
1 comprises the following ‘dangerous fluids’5, as classified on the basis of their intrinsic 
properties and the degree and specific nature  of the hazards involved in Directive 
67/548/EEC: explosive, extremely flammable, highl y flammable, flammable, very toxic, toxic 
and oxidising. Group 2 comprises all other fluids  not referred to in Directive 97/23/EC as 
‘dangerous’. 
                                                                                                                                                         
Member States relating to equipment and protective systems intended for use in potentially explosive 
atmospheres (COM(2011) 772 final); Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of Member States relating to the making available on the 
market of electrical equipment desi gned for use within certain voltage limits (COM(2011)773 final). 
3 Proposal for a Regulation of the European Parlia ment and of the Council on market surveillance of 
products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 
94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 
2011/65/EU, Regulation (EU) No 302/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 
765/2008 of the European Parliament and of the Council. COM(2013) 75 final. 
4 OJ 196, 16.8.1967, p.1. 
5 According to Article 9 of Directive 97/23/EC, ‘a dangerous fluid is a substance or preparation covered 
by the definitions in Article 2(2) of Council Directive 67/548/EEC’. EN 5   EN To take account of the pressure hazards associ ated with dangerous fluids, the conformity 
assessment requirements of Directive 97/23/EC are more stringent for pressure equipment 
containing Group 1 fluids than for pressu re equipment containing Group 2 fluids. 
According to Regulation (EC) No 1272/2008, Di rective 67/548/EEC will be repealed on 1 
June 2015 and replaced by the Regulation. That Re gulation introduces new hazard classes and 
categories only partially co rresponding to those used under the current provisions. 
The fluid classification criteria of Directiv e 97/23/EC must therefore be aligned to the 
classification criteria of Regulation (EC) No 1272/2008 un til 1 June 2015, while maintaining 
the existing levels of prot ection of the Directive. 
The alignment of Directive 97/ 23/EC to the CLP Regulation re quires therefore redefining 
what constitutes a ‘dangerous fluid’ in the terms of the new classification introduced by the 
Regulation. 
The need to align the fluid classification crite ria of Directive 97/23/EC  to the CLP Regulation 
is therefore a direct consequence of implem enting the CLP Regulation in the Union, which 
requires all downstream legislatio n to be aligned to the CLP Re gulation at the latest by the 
date on which Directive 67/548/EEC will be repealed (1 June 2015). 
Although the two classification systems provi ded by the CLP Regulation and Directive 
67/548/EEC are similar, there is no perfect match. Some substances  are classified differently 
under the CLP Regulation than under Directiv e 67/548/EEC due to changes in the 
classification criteria or cut-off values. A change in the classification of the fluid (substance or 
preparation) contained in the pressure equipment may therefor e result in a change of the 
classification of the pressure equipment it self (categories of pressure equipment). 
Directive 97/23/EC provides for four categorie s of pressure equipment, according to the 
ascending pressure related hazard. For each ca tegory of pressure equipment, the Directive 
provides for a set of conformity assessment pro cedures. Pressure equipment must be subject 
to one of the conformity assessment procedur es which may be chosen by the manufacturer 
among those laid down for the category in which the pressure equipment is classified. The 
manufacturer may also choose to apply one of the procedur es which apply to a higher 
category, if available.  
The change in category under Directive 97/23/EC is having an impact only on the conformity 
assessment procedure and not on the design or manufact uring of the pressure equipment itself. 
If pressure equipment is classified in a hi gher category due to the fluid it contains, it may 
result in a more demanding and more expe nsive conformity assessment procedure. 
As the current provision6 related to the classification of pr essure equipment based also on the 
characteristics of the fluid it contains is cons idered satisfactory, Dir ective 97/23/EC should be 
aligned to the CLP Regulation while maintaining the current scope in relation to the hazards 
due to the fluids. The new clas sification of the fluids should  therefore match as close as 
possible the current classificati on based on Directive 67/548/EEC.  
                                                 
6 Article 9 of Directive 97/23/EC. EN 6   EN The proposed alignment is therefore a technica l alignment primarily designed to minimize the 
impact of the changes in the classification system of the fluids introduced by the CLP 
Regulation on the classification of the pressure equipment itself.  
Consistency with other policies and objectives of the Union 
This initiative is in line with the Single Market Act7, which stressed the need to restore 
consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance. 
Furthermore it supports the Commission’s polic y on Better Regulation and simplification of 
the regulatory environment. 
2. CONSULTATION
 OF THE  INTERESTED  PARTIES  AND  IMPACT  
ASSESSMENT 
Consultation of interested parties 
a) The alignment of Directive 97/23/EC to the NLF Decision has been discussed with 
national experts responsible for the implemen tation of the Directive, the conformity 
assessment bodies’ forum, the administrative  cooperation group on mark et surveillance as 
well as in bilateral contacts with industry associations.  
From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted quest ionnaires for economic operators, 
authorities, conformity assessment bodies and users and the Commission services received 
300 replies. The results are published at:  
http://ec.europa.eu/enterprise /policies/single-mar ket-goods/internal-market-for-products/new-
legislative-framework/index_en.htm  
In addition to the general cons ultation a specific SME consulta tion was carried out. 603 SMEs 
were consulted through the En terprise Europe Network in May/June 2010. The results are 
available at http://ec.europa.eu/ enterprise/policies/ single-market-goods/f iles/new-legislative-
framework/smes_statistics_en.pdf  
The consultation process revealed widespread su pport for the initiative. There is unanimity on 
the need to improve market surveillance and the system for assessing and monitoring 
conformity assessment bodies. Authorities fu lly support the exercise because it will 
strengthen the existing system and improve coope ration at EU level. In dustry expects a more 
level playing field resulting fr om more effective actions against products that do not comply 
with the legislation, as well as  a simplification effect from the alignment of legislation. 
Certain concerns were expressed on some oblig ations which are, however, indispensable for 
increasing the efficiency of market surveilla nce. These measures will not entail significant 
costs for industry and the benefits resulting fr om improved market surveillance should by far 
outweigh the costs.  
                                                 
7 Communication from the Commission to the European  Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions, COM(2011) 206 final. EN 7   EN b) The alignment of Directive 97/23/EC to the CLP Regulation has been discussed with 
national experts responsible for the implemen tation of the Directive, the conformity 
assessment bodies’ forum, the administrative coope ration group as well as in  bilateral contacts 
with industry associations.  
An impact assessment study on the alignment of  Directive 97/23/EC to the CLP Regulation 
was conducted in 2012. 
In the context of this study, a survey wa s organised amongst ke y stakeholders. The 
Commission organised a work shop on 7 November 2012 in order to collect further 
information and to allow direct interaction w ith stakeholders. The workshop was attended by 
representatives of national au thorities, user and manufactur er associations, conformity 
assessment bodies, standardisers and expert s in the field of the CLP Regulation. 
Collection and use of expertise - Impact assessment  
a) Impact assessment concerning th e alignment to the NLF Decision 
In addition to the general impact assessment for the New Legislative Framework, an impact 
assessment was conducted for the NLF implemen tation package adopted in November 2011. 
That impact assessment covered also the a lignment of Directive 97/23/EC to the NLF 
Decision and was largely built on the general  impact assessment carried out for the New 
Legislative Framework. In addition to the exper tise collected and analysed in that context, 
further consultation of the sect or-specific experts a nd interest groups, as well as horizontal 
experts active in the area of technical harmonisation, conform ity assessment, accreditation 
and market surveillance, has taken place. 
Based on the information collected, the Commissi on carried out an impact assessment which 
examined and compared three options. 
Option 1 - No changes to  the current situation  
This option proposes no changes to the current  directive and relies exclusively on certain 
improvements that can be expected from the NLF Regulation. 
Option 2 – Alignment to the NLF Deci sion by non-legislative measures 
Option 2 considers the possibility  of encouraging a voluntary ali gnment to the provisions set 
out in the NLF Decision by, e.g., presenting them  as best practices in guidance documents. 
Option 3 – Alignment to the NLF D ecision by legislative measures 
This option consists in integrating the provisions of the NLF Decision into Directive 
97/23/EC. 
Option 3 was found to be the preferred option because: 
– it will improve the competitiveness of companies and conformity assessment 
bodies taking their obligations seriously; EN 8   EN – it will improve the functioning of the inte rnal market by ensuring equal treatment 
of all economic operators, notably impor ters and distributors, as well as 
conformity assessment bodies; 
– it does not entail significant costs fo r economic operators and conformity 
assessment bodies; for those who are alrea dy acting responsibly, no extra costs or 
only negligible costs are expected; 
– it is considered more effective than option 2: due to the lack of enforceability of 
option 2 it is questionable that the positive impacts would materialise under that option; 
– options 1 and 2 do not provide answers to the problem of inconsistencies in the 
regulatory framework and therefore have no positive impact on the simplification of the regulatory environment. 
As outlined above in option 3, the alignment of Directive 97/23/EC to the NLF Decision will 
lead to a better implementation of the Directive.  
The proposal includes: 
• Measures to address the problem of non-compliance by clarifying the 
obligations of economic operators and requiring enhanced traceability 
requirements.  
• Measures intended to ensure the qua lity of work done by conformity 
assessment bodies by reinforcing the notification requirements, revised 
notification process, specif ying requirements for notifyi ng authorities and more 
stringent information obligations. 
• Measures intended to ensure greater consistency amongst Directives by 
aligning commonly used definitions and terminology and aligning the 
conformity assessment procedures.  
The impact of these measures will lead to st rengthening the competi tiveness of European 
enterprises as a result of guaranteeing a le vel playing field for the economic operators. 
b) Impact assessment concerning the alignment to the CLP Regulation 
The alignment of Directive 97/23/EC to the CLP Regulation is a direct consequence of 
implementing the CLP Regulation in the Union. 
In particular, the classification of hazardous subs tances and mixtures is regulated at European 
level by the CLP Regulation which transposes the international Global Harmonised System 
(GHS) in the EU. 
Therefore, the objective of the alignment of Directive 97/23/EC to the CLP Regulation is to 
ensure legal coherence. Such an alignment re quires only the modificati on of Article 9(2) of 
Directive 97/23/EC.  EN 9   EN A non-alignment to the CLP Regulation would lead  to legal uncertainty as from 1 June 2015, 
when Directive 67/548/EEC will be repealed, b ecause, as from this date, there would be no 
legal basis for the classification of pressu re equipment based on the fluid it contains. 
The evaluation study of Directive 97/23/EC completed in November 2012, concluded that 
there is no urgent need for a full revision of Directive 97/23/EC. Better implementation of the 
Directive can be achieved by introducing the NLF provisions and by complementary 
measures such as improving the market surv eillance. Additional studi es should be conducted 
before preparing a full revision of the Directive, analysing e .g. issues relate d to the scope, 
technical provisions related to th e essential safety requirements, etc… It also confirmed that 
the current classification mechanism of the pr essure equipment provided for by the Directive 
and based also on the classificati on of the fluid is satisfactory. 
The proposed alignment options are the result of  a technical mapping of the current hazard 
classes of dangerous substances  and preparations provided for by Dire ctive 97/23/EC and 
based on Directive 67/548/EEC to the hazard classes for the classification of substances and 
mixtures classified as hazardous in accordan ce with the CLP Regulation. This technical 
mapping results to minimal changes to the ex isting classification system of pressure 
equipment provided for by Directive 97/23/EC. 
Similar to the current provisions  of Directive 97/23/EC, the pr oposal should therefore address 
the physical and health hazards due to the fluids contained in the pressure equipment, as far as 
relevant for the classification of pressure equi pment in view of its conformity assessment.  
For most pressure equipment there will be no change of the classification of the equipment 
due to the alignment to the CLP Regulation.  
The best possible mapping between Directive 67/548/EEC and the CLP Regulation should be 
envisaged reducing the impact of this change to the minimum. The technical detail of the 
alignment and the options chosen on how to modi fy Article 9(2) of Di rective 97/23/EC could 
lead to increasing or reducing the number of substances or mixtures included in Group 1 of 
Directive 97/23/EC (the group which imposes more demanding requirements with regard to 
the conformity assessment procedures). 
The impact of the various opti ons has been analysed in an impact assessment study on the 
alignment of Directive 97/23/EC to the CLP Regulation, finalised in February 2013. 
It results from the analysis that whilst there will be changes in the terminology used to 
identify the hazards, only a small number of flui ds will be classified in a different group under 
Directive 97/23/EC possibly leading to a differ ent classification of the pressure equipment 
itself.  
A possible change in the classification of the fluids under Directive 97/23/EC does not always 
necessarily result in a differe nt classification of the pressure equipment itself since such 
classification of the equipment depends not only on the nature of the fluid but also on the total 
energetic content (based on the pressu re and the volume of the equipment). 
In particular, the transition from Directive 67/548/EEC to the CLP Regulation for physical 
hazards is reasonably smooth as there is a good matching between that Directive and the new 
classification under the CLP Regulation. Only fo r a few substances the classification will 
change because the CLP Regulation introduces new cut-off values for the flammability criteria. EN 10   EN The transition from Directive 67/548/EEC to th e CLP Regulation for the health hazards is 
more complex as the boundaries of some cate gories do not always align with those of 
Directive 67/548/EEC, as the CLP Regulatio n introduces also new hazard classes and 
categories. 
In particular, the hazard classes and categories related to acute toxicity have been analysed 
more in detail with regard to their potential safety and economic impact. 
With regard to the hazard classes for acute toxicity, the findings can be summarized as 
follows: 
- the inclusion of the fluids that are classifi ed under the hazard classes acute oral toxicity 
category 1 and 2 in Gro up 1 under Directive 97/23/EC will lead to a decreas e in the number 
of fluids (in the meaning of substances or preparations) in Group 1. This option is supported 
by the fact that the oral take-up of substances or mixtures due to  failure of pressure equipment 
cannot be excluded but the risk is very limite d. This option would therefore not cause an 
unacceptable safety risk. However, the inclusion of acute oral toxicity category 3 would lead to a substantial increase in the number of fl uids in Group 1, possibly resulting in a higher 
category of the equipment which may lead to an increase of the costs of the conformity 
assessment, without a substantial gain in the level of safety. 
- the inclusion of the fluids that are classified  under the hazard classes acute dermal toxicity 
category 1 and 2 will lead to a small decrease in the number of fluids (in the meaning of 
substances or preparations) in Group 1 under Di rective 97/23/EC. This option is supported by 
the fact that dermal contact with substances or  mixtures due to failure  of pressure equipment 
cannot be excluded but the risk is rather limited and would not cause an unacceptable safety risk. However, the inclusion of acute dermal to xicity category 3 would lead to a relatively 
small increase in the number of fluids in Group  1, without a substantial gain in the level of 
safety. 
- the inclusion of the fluids that are cla ssified under the hazard classes acute toxicity 
inhalation category 3 in addition to category 1 and 2 will lead to an incr ease of fluids (in the 
meaning of substances or preparations) in Group 1 under Directive 97/23/EC which is 
justified given the risk that might exist due to  small leakages of fluids in the pressure 
equipment. 
In summary, for most of the fluids used in pre ssure equipment, there will be no change in the 
classification of the equipment due to the alignment to the CLP Regulation. For a limited number of fluids, used in a limited number of applications, the alignment to the CLP 
Regulation may lead to a different classificatio n of the equipment and may influence the cost 
for the conformity assessment process. 
The impact assessment study conc luded that the impact of th e proposed alignment would be 
limited and in particular that the overall econo mic impact will be low considering that the 
proposed alignment options are aiming at the best possible mapping between the current 
classification (based on Directive 67/548/EEC)  and the future one (based on the CLP 
Regulation). 
Based on the number of substances that would be  subject to a different classification and the 
proportion of manufacturer s that would be affected, the im pact assessment study estimates the 
overall costs of aligning Direct ive 97/23/EC to the CLP Regulat ion to be of the order of 8,5 EN 11   EN million euros per year. The cost is due to the ch anges in the alignment for the health hazard 
classes. 
However, looking at the current compliance co sts, and according to the impact assessment 
study, the total average cost of the conformity assessment for the pressure equipment covered 
by Directive 97/23/EC is estimated at 236,3 million euros per year.  
Therefore, the incremental cost due to the alignment of Directive 97/23/EC to the CLP 
Regulation is low compared to the total cost for conformity assessment. However, the implementation of the CLP Regulation in the Union is mandatory an d the cost cannot be 
avoided. 
The impact assessment study is available at:  
http://ec.europa.eu/enterp rise/sectors/pressure-and-gas/documents/ped/index_en.htm
 
On the basis of the above, the Commission concluded that: 
a) There is no alternative c ourse of action because all downstream legislation which is 
using classification of chemical substances has to be aligned to the CLP Regulation, which is 
the European Union initiative transposing the international Global Harmonised System (GHS) in the EU. The current legal basis for the cl assification of substan ces and preparations, 
referred to in Article 9(2.1) of Directive 97/ 23/EC, namely Directive 67/548/EEC, will be 
repealed on 1 June 2015. By that time, Directive 97/23/EC should be modified and refer to the 
CLP Regulation for the purpose of the classifica tion of pressure equipment within its scope. 
The proposed alignment is therefore a technical  alignment which is primarily designed to 
minimize the impact of the changes in the cla ssification system of the pressure equipment 
itself and to guarantee legal ce rtainty as from 1 June 2015. 
b) The impact assessment study did not identi fy significant economic or health related 
impacts.  
3. MAIN ELEMENTS OF THE PROPOSAL 
3.1. Horizontal definitions 
The proposal introduces harmonised definitions of terms which are commonly used 
throughout Union harmonisation le gislation and should therefor e be given a consistent 
meaning throughout that legislation.  
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obligat ions of manufacturers and au thorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble to authorities upon request. Furthermore 
importers must verify that pressure equipmen t is correctly marked and accompanied by the 
instructions and safety information. They must keep a copy of the Decl aration of conformity 
and indicate their name and address on the pr oduct, or where this is not possible on the 
packaging or the accompanying documentation. Distributors must verify that pressure EN 12   EN equipment bears the CE marking, the name of the manufacturer and of the importer, if 
relevant, and that it is accompanied by th e required documentation and instructions. 
Importers and distributors must cooperate w ith market surveillance authorities and take 
appropriate actions when they have supp lied non-compliant pressure equipment. 
Enhanced traceability obligations  are introduced for all economic operators. Pressure 
equipment has to bear the manufacturer’s name and address and a number allowing to identify 
and link the pressure equipment to its techni cal documentation. When pressure equipment is 
imported the importer’s name and address mu st also be on the pressure equipment. 
Furthermore every economic operator must be able to identify towards authorities the 
economic operator who has supplied him with pressure equipment or to whom he has 
supplied pressure equipment. 
3.3. Harmonised standards 
Compliance with harmonised standards provides for a presumption of conformity with the 
essential requirements. Regulation (EU) No 1025/ 2012 of the European Parliament and of the 
Council of 25 October 2012 on European Sta ndardisation, 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 repeali ng Council Decision 87/95/EEC and Decision No 
1673/2006/EC of the European Pa rliament and of the Council8 sets out a horizontal legal 
framework for European standardisation. The Re gulation contains inte r alia provisions on 
standardisation requests from the Commission to  the European Standardisation Organisation, 
on the procedure for objections to harmonised standards and on stakehol der participation in 
the standardisation process. Consequently, it  repealed Article 6 of  Directive 97/23/EC 
covering the same aspects.  The provision conferring pres umption of conformity to 
harmonised standards has been modified to clarify the extent of  the presumption of 
conformity when standards only partiall y cover the essential requirements.  
3.4. Conformity assessment and CE marking 
Directive 97/23/EC has selected the appropria te conformity assessment procedures which 
manufacturers have to apply in order to dem onstrate that their pressure equipment complies 
with the essential safety requirements. The prop osal aligns these proc edures to their updated 
versions set out in the NLF Decision.  
General principles of the CE marking are se t out in Article 30 of  Regulation (EC) No 
765/2008, while the detailed provisions on the affixing of the CE marking to pressure 
equipment have been inserted in this proposal. 
3.5. Conformity assessment bodies 
The proposal reinforces the notif ication criteria for conform ity assessment bodies, namely 
notified bodies but also recognised third-party organisations and user  inspectorates.  It clarifies 
that subsidiaries or subcontractors must also comply w ith the notification requirements. 
Specific requirements for notifying authoriti es are introduced and the procedure for 
notification of notified bodies and user inspectorates and for designation of recognised third-
                                                 
8 OJ L 316, 14.11.2012, p.12. EN 13   EN party organisations is revised. The competen ce of conformity assessment bodies must be 
demonstrated by an accreditation certificate.  Where accreditation has not been used to 
evaluate the competence of a conformity asse ssment body, the notification must comprise the 
documentation demonstrating how the competence of that body has been  evaluated. Member 
States will have the possibility  to object to a notification. 
3.6. Market surveillance and the safeguard clause procedure 
On 13 February 2013, the Commission adopted a proposal for a Regulation on market 
surveillance of products, which intends to set out a single legal instrument on the market 
surveillance activities in the field of non-food goods, consum er or non-consumer products and 
products covered or not by Union harmonisation legislation. The proposal merges the rules on 
market surveillance of Directive 2001/95/EC on general product safety9, Regulation (EC) No 
765/2008 and sector- specific harmonisation legislati on in order to increase the effectiveness 
of market surveillance activities within the Union. The pro posed Regulation covers also the 
reference provisions on market surveillance and safeguard clauses contained in the NLF 
Decision. Therefore, provisions in existing Uni on harmonisation legislation that relate to 
market surveillance and safeguard clauses should be removed from that harmonisation 
legislation. 
The overarching objective of the proposed Re gulation is to simplify the Union market 
surveillance framework fundamentally so that it works better for its main users: market 
surveillance authorities and economic operators. This will re sult in a better implementation of 
the market surveillance rules across Member St ates, providing better protection for consumers 
and other users, reduced admini strative burdens and enhanced information and work-sharing 
between market surveillance authorities. 
In this framework, the proposed Regulation will lead to a better impl ementation of Directive 
97/23/EC, which covers consumer and non-consumer products, and to an improved competitiveness framework in the internal market. 
On this basis, the proposal does not include pr ovisions on market surveillance and safeguard 
clause procedures, but in order to ensure lega l clarity, it makes a reference to the proposed 
Regulation on market surveillance of products.  
3.7. Classification of pressure equipment 
The proposal modifies Article 9(2) of Directiv e 97/23/EC so as to a lign, for purposes related 
to the conformity assessment of the pressure equipment, the current cl assification of fluids 
contained in the equipment and which is based on the classification of dangerous substances 
and preparations provided for by Directiv e 67/548/EEC, to the new classification of 
hazardous substances and mixtures provided for by the CLP Regulation. 
3.8. Comitology and delegated acts 
The provisions on the operation of the Committee on Pressure Equipment have been adapted 
to the new rules on delegated acts laid down in Artic le 290 of the Treat y on the Functioning 
of the EU and to the new pr ovisions on implementing acts laid  down in Regulation (EU) No 
182/2011 of the European Parliament and of th e Council of 16 February 2011 laying down the 
                                                
 
9 OJ L11, 15.1.2002, p.4. EN 14   EN rules and general principles concerning mechanis ms for control by the Member States of the 
Commission's exercise of implementing powers10. 
4. LEGAL ELEMENTS OF THE PROPOSAL 
Legal basis  
The proposal is based on Article 114 of the Tr eaty on the Functioning of the European Union. 
Subsidiarity principle 
The internal market is a competence that is sh ared between the Union and the Member States. 
The subsidiarity principle aris es in particular with regard  to the newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 97/23/EC, namely, the 
importer and distributor obligations, the tr aceability provisions, the provisions on the 
assessment and notification of conformity a ssessment bodies, and the enhanced cooperation 
obligations in the context of the revised ma rket surveillance and safeguard procedures.  
Experience with the enforcement of the legislat ion has shown that measures taken at national 
level have led to divergent ap proaches and to a different tr eatment of economic operators 
inside the EU, which undermines the objective of th is directive. If actions are taken at national 
level to address the problems, this risks cr eating obstacles to the free movement of goods. 
Furthermore action at national level is limited to the territorial competence of a Member State. 
In view of the increasing internationalisation of  trade, the number of cross-border cases is 
constantly rising. Coordinated ac tion at EU level can much be tter achieve the objectives set, 
and will in particular render market surveillance  more effective. Hence it is more appropriate 
to take action at EU level. 
As regards the problem of inconsistencies thro ughout the directives, th is is a problem which 
can only be solved by the EU legislator. 
In accordance with the principle of proportional ity, the modifications to be proposed will not 
go beyond what is necessary to achieve the objectives set. 
Proportionality  
In accordance with the principle of proportiona lity, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - or administrations . Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to provide the most proportionate respons e to the problems identified. A number of 
modifications concern the improvement of cl arity of the existing Directive without 
introducing new requirements th at entail added cost.  
Legislative technique used 
                                                 
10 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and the 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). EN 15   EN The alignment to the NLF Decision and to the CLP Regulation requires a number of 
substantive amendments to the provisions of Dir ective 97/23/EC. To ensure the readability of 
the amended text the technique of recasting has b een chosen in line with the Inter-institutional 
Agreement of 28 November 2001 on a more structur ed use of the recasti ng technique for legal 
acts11.  
The changes made to the provisions of Dir ective 97/23/EC concern: the definitions, the 
obligations of economic operators, the presum ption of conformity provided by harmonised 
standards, the declaration of conformity, CE marking, conformity assessment bodies, the 
safeguard clause procedure, the conformity a ssessment procedures and the classification of 
the fluids. 
The proposal does not change th e scope of Directive 97/23/EC  and the esse ntial safety 
requirements.  
5. BUDGETARY  IMPLICATION   
This proposal does not have any implications for the EU budget. 
6. ADDITIONAL  INFORMATION 
Repeal of existing legislation 
The adoption of the proposal will lead to rep eal of Directive 97/23/EC as from 1 June 2015. 
In particular, in order to ensure the simu ltaneous and coherent implementation of the 
alignment of Directive 97/23/ EC to Decision 768/2008/EC a nd to Regulation (EC) No 
1272/2008, the proposal provides that  the new Directive will apply as from 1 June 2015. 
European Economic Area 
The proposal concerns the EEA and should therefore be extended to the European Economic 
Area.
                                                 
11 OJ C 77, 28.3.2002, p. 1.  EN 16   EN  
Ð 97/23/EC (adapted) 
2013/0221 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the approximation  ⌦ harmonisation ⌫ of the laws of the Member States 
concerning  ⌦ relating to making ava ilable on the market of ⌫ pressure equipment 
(Recast) 
 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European Community  ⌦ on Functioning of the 
European Union ⌫ and in particular Article 100a  ⌦ 114 ⌫ thereof, 
Having regard to the proposals 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
12, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
 
Ø new 
(1) Directive 97/23/EC of the European Pa rliament and of the Council of 29 May 1997 on 
the approximation of the laws of the Memb er States concerning pressure equipment13 
has been substantially amended several time s. Since further amendments are to be 
made, it should be recast in the interests of clarity. 
(2) Regulation (EC) No 765/2008 of the European  Parliament and of the Council of 9 July 
2008 setting out the requirements for accredi tation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/9314 lays down 
rules on the accreditation of c onformity assessment bodies [provides a framework for 
the market surveillance of products and for c ontrols on products from third countries,] 
and lays down the general principles of the CE marking. 
                                                 
12 OJ C […], […], p. […]. 
13 OJ L 181, 9.7.1997, p. 1. 
14 OJ L 218, 13.8.2008, p. 30. EN 17   EN (3) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 
2008 on a common framework for the marketi ng of products and repealing Council 
Decision 93/465/EEC15 lays down a common framework of general principles and 
reference provisions intended to apply across the legislation harmonising the 
conditions for the marketing of products in  order to provide a coherent basis for 
revision or recasts of that legislation. Di rective 97/23/EC should therefore be adapted 
to that Decision. 
 
Ð 97/23/EC recital 1  (adapted)  
Whereas t he internal market is an  area without internal frontiers in which the free 
movement of goods, persons, services and capital is ensured;  
 
Ð 97/23/EC recital 2 
Whereas t here are differences in the content an d scope of the laws, regulations and 
administrative provisions in force in the Memb er States with regard to the safety and 
protection of health of persons and, where appropriate, domestic animals or property, 
where pre ssure equipment not covered by pr esent Community legislation is 
concerned; whereas the certification and in spection procedures for such equipment 
differ from one Member State to anothe r; whereas such di sparities may well 
constitute barriers to trade within  the Community;  
 
Ð 97/23/EC recital 3 
Whereas the harmonization of national legisl ation is the only means of removing 
these barriers to free trade; whereas this  objective cannot be achieved satisfactorily 
by the individual Member States; wher eas this Directive only lays down 
indispensable requirements for the free circulation of the equipment to which it is 
applicable;  
 
Ð 97/23/EC recital 4 (adapted) 
(4) Whereas equipment subject to a pressu re of not more than 0,5 bar does not po se a 
significant hazard due to pressure; whereas there should not therefore be any obstacle 
to its free movement within the Community;  This Directive applies  ⌦ should 
apply ⌫ to equipment subject to a maximum allowable pressure PS exceeding  
⌦ greater than ⌫ 0,5 bar. ⌦ Equipment subject to a pres sure of not more than 0,5 
bar does not pose a significant risk due to pr essure. Therefore, there should not be any 
obstacle to its free movement within the Union. ⌫ 
 
Ð 97/23/EC recital 5 (adapted) 
(5) This Directive relates also  ⌦ should also apply ⌫ to assemblies composed of several 
pieces of pressure equipment assembled to  constitute an integrated and functional 
whole. Th ese ⌦ Those ⌫ assemblies may range from simple assemblies such as 
pressure cookers to complex assemblies such as water tube boilers. If the manufacturer 
                                                 
15 OJ L 218, 13.8.2008, p. 82. EN 18   EN of an assembly intends it  to be placed  ⌦ 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 must 
conform  to ⌦ should comply with ⌫ this Directive. 
On the other hand  ⌦ However ⌫, this Directive does not cover  ⌦ should not apply 
to ⌫ the assembly of pressure equipment on the site and under the responsibility of 
the user, as in the case of  industrial installations. 
 
Ð 97/23/EC recital 6 (adapted) 
(6) This Directive harmoni ses ⌦ should harmonise ⌫ national provisions on hazards  
⌦ risks ⌫ due to pressure. The other hazards  ⌦ risks ⌫ which this equipment 
may present accordingly  may fall within the scope of other Directives dealing with 
such hazards  ⌦ those risks ⌫. 
(7) However, ⌦ some ⌫ pressure equipment may be included among products  ⌦ is ⌫ 
covered by other Directives based on Article 100a  ⌦ 114 ⌫ of the Treaty. The 
provisions laid down in some of those Directives deal ⌦ also ⌫ with the hazard  
⌦ risk ⌫ due to pressure. Those provisions  ⌦ Directives ⌫ are considered 
adequate to provide appropria te protection where the hazard  ⌦ risk ⌫ due to 
pressure associated with such equipment remains small. Therefore, there are grounds 
for excluding  such equipment ⌦ should be excluded ⌫ from the scope of this 
Directive. 
 
Ð 97/23/EC recital 7 (adapted) 
Ö new 
(8) For ⌦ some ⌫ pressure equipment covere d by international Conventions , 
⌦ agreements for its international transport, national ⌫ transport and pressure 
hazards  ⌦ risks ⌫ are due to be  dealt with as soon as possible  by forthcoming 
Community  ⌦ Union ⌫ Directives based on such Conventions  ⌦ agreements ⌫ 
or by supplements to existing Directives  Ö by extending the ap plication of those 
agreements to national transport, in orde r to ensure the free movement of such 
dangerous goods whilst enhancing transport safety . Such equipment Ö which is 
covered by Directive 2008/68/EC of the Europe an Parliament and of the Council of 29 
September 2008 on the inland transport of dangerous goods16 and by Directive 
2010/35/EU of the European Parliament and of the Council of 16 June 2010 on 
transportable pressure equipment and re pealing Council Directives 76/767/EEC, 
84/525/EEC, 84/526/EEC, 84/ 527/EEC and 1999/36/EC17  is accordingly  ⌦ should 
be ⌫ excluded from the scope of this Directive. 
 
Ð 97/23/EC recital 8 (adapted) 
(9) Certain types of pressure equipment,  although subject to a maximum allowable 
pressure PS higher  ⌦ greater ⌫ than 0,5 bar, do not pres ent any signif icant hazard  
⌦ risk ⌫ due to pressure, and therefore the freedom  of ⌦ free ⌫ movement of 
such equipment in the Community  ⌦ Union ⌫ should not be hindered if it has been 
legally manufactured or placed on the market in a Member Stat. It is not necessary in 
                                                 
16 OJ L 260, 30.9.2008, p.13. 
17 OJ L 165, 30.6.2010, p.1. EN 19   EN order to ensure free movement of such equi pment to include it in the scope of this 
Directive. Consequently it is  ⌦ should be ⌫ expressly excluded from its scope. 
 
Ð 97/23/EC recital 9 (adapted) 
(10) Other pressure equipment subject to a maximum allowable pressure higher  
⌦ greater ⌫ than 0,5 bar and presenting a significant hazard  ⌦ risk ⌫ due to 
pressure, but in respect of wh ich free movement and an appropriate level of safety are 
guaranteed, is  ⌦ 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. 
 
Ð 97/23/EC recital 10 
Whereas regulations to remove technical barriers to trade must follow the new 
approach provided for in the Council Re solution of 7 May 1985 on a new approach 
to technical harmonization and standards18, which  requires a definition of the 
essential requirements regarding safety a nd other requirements of society without 
reducing existing, justified levels of prot ection within the Member States; whereas 
that Resolution provides that a very large number of product s be covered by a single 
Directive in order to avoid frequent amendm ents and the proliferation of Directives;  
 
Ð 97/23/EC recital 11 
Whereas t he existing Community Directives on the approximation of the laws of the 
Member States relating to p ressure equipment have made positive steps towards 
removing barriers to trade in this are a; whereas t hose Directives cover that sector 
only to a minor exten t; whereas  Council Directive 87/404/EEC of 25 June 1987 on 
the harmonization of the laws of the Memb er States relating to simple pressure 
vessels19 is the first case of application of the new approach to the sector of pressure 
equipmen t; whereas  the present Directive will not apply to the area covered by 
Directive 87/404/EEC; whereas , no later than three years after the present Directive 
enters into force, a review will be carri ed out of the application of Directive 
87/404/EEC in order to ascertain the need fo r the integration ther eof into the present 
Directive;  
 
Ð 97/23/EC recital 12 
Whereas  the framework Directive, Council Di rective 76/767/EEC of 27 July 1976 on 
the approximation of the laws of the Memb er States relating to common provisions 
for pressure vessels and methods for inspecting them20 is optional; whereas it 
provides for a procedur e for the bilateral recognition of testing and certification of 
pressure equipment which did not operate sa tisfactorily and which therefore must be 
replaced by effective Community measures;  
                                                 
18 OJ No C 136, 4.6. 1985, p. 1.  
19 OJ No L 220, 8.8.1987, p. 48. Directive as  last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 
1993, p. 1).  
20 OJ No L 262, 2 7.9.1976, p. 153. Dir ective as last amended by the 1994 Act of Accession.  EN 20   EN  
Ð 97/23/EC recital 13 (adapted) 
(11) The scope of this Directive must  ⌦ should ⌫ be based on a general definition of the 
term «pressure equipment» so as to allo w for the technical development of products. 
 
Ð 97/23/EC recital 14 (adapted) 
(12) Compliance with the essential safety requi rements is necessary in order to ensure the 
safety of pressure equipment. Those requirements have been  ⌦ should 
be ⌫ subdivided into general and specific requirements which m ust ⌦ that need 
to ⌫ be met by pressure equipment. In particular the specific requirements are 
intended to  ⌦ should ⌫ take account of particular types of pressure equipment. 
Certain types of pressure equipm ent in categories III and IV must  ⌦ should ⌫ be 
subject to a final assessment comprisi ng final inspection and proof tests. 
 
Ð 97/23/EC recital 15 (adapted) 
(13) 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, appropr iate safety measures must
 ⌦ should ⌫ be taken in 
accordance with the general safety rules of the Member State concerned to ensure the 
safety of persons. 
 
Ø new 
(14) Directive 97/23/EC provid es for a classification of pre ssure equipment in categories, 
according to the ascending level of risk due to pressure. This includes the 
classification of the fluid contained in th e pressure equipment as dangerous or not, 
according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of 
the laws, regulations and administrative pr ovisions relating to the classification, 
packaging and labelling of dangerous substances21. 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 Counc il of 16 December 2008 on classification, 
labelling and packaging of substances and mixtures22, which implements in the Union 
the Globally Harmonised System of Classifica tion and Labelling of Chemicals that has 
been adopted at international level, w ithin the United Nations (UN) structure. 
Regulation (EC) No 1272/2008 introduces ne w 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 of th at Directive. 
(15) Economic operators should be responsible for the compliance of pressure equipment 
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 and the protection of user s, and to guarantee fair competition on the 
Union market. 
                                                 
21 OJ 196, 16.8.1967, p. 1. 
22 OJ L 353, 31.12.2008, p. 1. EN 21   EN (16) All economic operators in tervening in the supply and distribution chain should take 
appropriate measures to ensure that they only make available on the market pressure 
equipment which is in conformity with this Directive. It is necessary to provide for a 
clear and proportionate distribut ion of obligations which corre spond to the role of each 
economic operator in the s upply and distribution chain. 
(17) The manufacturer, having detailed knowle dge of the design and production process, is 
best placed to carry out the complete c onformity assessment procedure. Conformity 
assessment should therefore remain solely  the obligation of the manufacturer. 
(18) In order to faci litate the communicati on between economic operators, national market 
surveillance authorities and consumers, Me mber States should encourage economic 
operators to indicate a website addre ss in addition to the postal address. 
(19) It is necessary to ensure that pressu re equipment from thir d countries entering the 
Union market complies 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.  Provision should therefore be made for 
importers to make sure that the pressure equipment they place on the market complies 
with the requirements of this Directive a nd that they do not place on the market 
pressure equipment which does 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 
and documentation drawn up by manufacturers are available for inspection by the 
national authorities. 
(20) The distributor makes pressure equipmen t available on the mark et after it has been 
placed on the market by the manufacturer or the importer and shoul d act with due care 
to ensure that its handling of the pressu re equipment does not adversely affect the 
compliance of the equipment with the requirements of this Directive. 
(21) When placing pressure equipment on the market, every importer  should indicate on 
the pressure equipment his name and the pos tal address at which he can be contacted. 
Exceptions should be provided for in cases wh ere the size or natu re of the pressure 
equipment does not allow it. This includes cases where the impor ter would have to 
open the packaging to put his name and address on the equipment.  
(22)  Any economic operator that either places  pressure equipment on the market under its 
own name or trademark or modifies pressure  equipment 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. 
(23) 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 t hose authorities with all necessary 
information relating to the pr essure equipment concerned. 
(24) Ensuring traceability of pressure equi pment throughout the whole supply chain helps 
to make market surveillance simpler and mo re efficient. An efficient traceability 
system facilitates market surveillance authorities' task of tracing economic operators 
who made non-compliant pressure equipment available on the market. EN 22   EN (25) When keeping the information required unde r this Directive for the identification of 
economic operators, economic operators s hould not be required to update such 
information in respect of other economic operators who have either supplied them 
with a pressure equipment or to whom th ey have supplied a pressure equipment. 
(26) This Directive should be limited to the expr ession of the essential safety requirements. 
In order to facilitate conformity assessmen t with those requirements it is necessary to 
provide for presumption of conformity for pr essure equipment which is in conformity 
with harmonised standards that are adopted  in accordance with Regulation (EU) No 
1025/2012 of the European Parliament an d of the Council of 25 October 2012 on 
European Standardisation, amending C ouncil 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 th e 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 Council23 for the purpose of expressing detailed 
technical specifications of t hose requirements, especially with regard to the design, 
manufacture and testing of  pressure equipment. 
(27) Regulation (EU) No 1025/2012 provides fo r a procedure for objections to harmonised 
standards where those standards do not entirely  satisfy requirements of this Directive. 
 
Ð 97/23/EC recital 16  
Whereas i n order to ease the task of demonstrating compliance with the essential 
require ments, standards harmoniz ed at European level are useful, especially with 
regard to the design, manuf acture and testing of pressu re equipment, compliance 
with which enables a product to be presumed  to meet the said essential requirement s; 
whereas standards  harmonized at European level are drawn up by private bodies and 
must retain their non -mandatory status; whereas, for this purpose, the European 
Committee for Standardization (CEN) and the European Committee for Electro -
technical  Standardization (Cenelec) are recognized as being the bodies that are 
competent to adopt harmonized standards that follow the general guidelines for 
cooperation between the Commission and those two bodies signed on 13 November 
1984;  
 
Ð 97/23/EC recital 17 
Whereas, for  the purposes of this Directive, a harmonized standard is a technical 
specification (European sta ndard or harmonization document) adopted by one or 
other of those bodies, or by both, at the request of the Commission pursuant to 
Council Directive 83/189/EEC  of 28 March 1983 laying down a procedure for the 
provision of information in the field of technical standards and regulations24 and in 
accordance with the general guidelines refe rred to above; whereas, in relation to 
standardization, it would be advisable for the Commission to be assisted by the 
Committee set up pursuant to Directive 83/ 189/EEC; whereas the Committee will, if 
necessary, consult technical experts;  
                                                 
23 OJ L 316, 14.11.2012, p. 12. 
24 OJ No  L 109,  26. 4. 1983, p. 8. Directive as  last amended by the 1994 Act of Accession.  EN 23   EN  
Ð 97/23/EC recital 18 (adapted) 
Ö new 
(28) Manufacturing of pressure equipment calls for the utilisation of safe materials. In the 
absence of harmonised standards, it is useful to define  the characteristics of the 
materials intended for repeated use ⌦ should be established. Those characteristics 
should be ⌫ . This definition is  established by European a pprovals for materials, such 
approvals being issued by one of the notifie d bodies specifically designated for that 
task. The materials conforming to the Eur opean approvals shall be presumed to sa tisfy 
⌦ should benefit from presumption of conformity with ⌫ the essential Ö safety  
requirements of this Directive. 
 
Ð 97/23/EC recital 19 (adapted) 
Ö new 
(29) In view of the nature of the hazards  ⌦ risks ⌫ involved in the use of pressure 
equipment Ö and in order to enable economic operators to dem onstrate and the 
competent authorities to ensu re that pressure equipment made available on the market 
conforms to the essential safety requirements,  it is necessary to establish  Ö provide 
for conformity assessment  procedures for assessing compliance with the basic 
requirements of the Directives . These procedures must  ⌦ should ⌫ be devised in the 
light of the level of danger wh ich is inherent in the pressu re equipment. Therefore, for 
each category of pressure equipment there must  ⌦ should ⌫ be an adequate 
procedure or a choice between different pr ocedures of equivale nt stringency. whereas 
the procedures adopted are as required  by Council Decision 93/465/EEC of 22 July 
1993 concerning the modules for the various phases of the conformity assess ment 
procedures and the rules for the affixing a nd use of the CE conformity marking, which 
are intended to be used in the technical harmonization Directives25; Ö 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 orde r to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, c onformity assessment procedures should be 
chosen from among those modules.  The details added to these  ⌦ those ⌫ 
procedures are justified by the nature of the verificat ion required for pressure 
equipment. 
 
Ð 97/23/EC recital 20 (adapted) 
(30) Member States should be in a position to authorize user inspectorates to carry out 
certain tasks for conformity assessment in the framework of this Directive. For that 
purpose this Directive ⌦ should ⌫ sets  out criteria for the authoriz sation of user 
inspectorates by Member States. 
                                                 
25 OJ No L 220, 30. 8. 1993, p. 23.  EN 24   EN  
Ð 97/23/EC recital 21 (adapted) 
(31) Under the conditions laid down by this Directive,  certain procedures for conformity 
assessment may require  ⌦ 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. In other cases provision  should be made to ensure that the final 
assessment may be monitored by a notif ied body by means of unexpected visits. 
 
Ø new 
(32) Manufacturers should draw up an EU declar ation of conformity to  provide information 
required under this Directive on the conformity of the pressure equipment with the 
requirements of this Directive and of othe r relevant Union harmonisation legislation. 
(33) To ensure effective access to inform ation for market surveillance purposes, the 
information required to identify all appli cable Union acts should be available in a 
‘single EU declaration of conformity’. 
 
Ð 97/23/EC recital 22 (adapted) 
Ö new 
(34) Pressure equipment will  ⌦ should ⌫, as a general rule, bear the CE marking. affixed 
either by the manufacturer or by his authorized rep resentative established within the 
Community; whereas the CE marking means that the pressure equipment complies 
with the provisions of this Directive a nd those of other applicable Community 
directives on CE marking ; Ö The CE marking, indicating th e conformity of pressure 
equipment, is the visible consequence of  a whole process comprising conformity 
assessment in a broad sense. General prin ciples governing the CE marking and its 
relationship to other markings are set out in Regulation (E C) No 765/2008. Rules 
governing the affixing of the CE marking should be laid down in this Directive .   
(35) For pressure equipment define d in this Directive which pr esents only a minor pressure 
hazard  ⌦ risk ⌫ and for which certification proce dures are therefore not justified, 
the CE marking will  ⌦ should ⌫ not be affixed. 
 
Ø new 
(36) The 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.  
(37) Experience has shown that the criteria set out in Directive 97/ 23/EC that conformity 
assessment bodies have to fulfil to be notif ied to the Commission are not sufficient to 
ensure a uniformly high level of performa nce of these bodies throughout the Union. It 
is, however, essential that a ll 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. EN 25   EN (38) In order to ensu re a consistent level of conformity assessmen t quality, it is also 
necessary to set requirements  for notifying authorities and other bodies involved in the 
assessment, notification and monitori ng of conformity assessment bodies. 
(39) If a conformity assessment body demonstrat es conformity with the criteria laid down 
in harmonised standards, it should be presumed to co mply with the corresponding 
requirements set out in this Directive. 
(40) The system set out in this Directiv e should be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since ac creditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(41) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in confor mity certificates, 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 author ities, they should 
provide the Commission and th e other Member States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(42) Conformity assessment bodies frequently su bcontract parts of thei r activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard 
the level of protection require d for the pressure equipment 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 monitori ng of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries.  
(43) It is necessary to increase the efficiency  and transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies so as to enable online notification. 
(44) Since conformity assessment bodies may offer their services throughout the Union, it 
is appropriate to give the other Member States and the Commi ssion 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. 
(45) In the interests of compet itiveness, 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 a pplication of the conformity assessment 
procedures needs to be ensured. That can  best be achieved through appropriate 
coordination and cooperation betwee n conformity assessment bodies. 
(46) Member States should take all appropriate measures to ensure that pressure equipment 
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 reasona bly foreseen, they do not EN 26   EN endanger the health and safety of persons. Pr essure equipment should be considered as 
non-compliant with the essential safety requirements laid do wn in this Directive only 
under conditions of use which can be reasonabl y foreseen, that is when such use could 
result from lawful and readily predictable human behaviour. 
 
Ð 97/23/EC recital 23 
Where as it is appropriate that the Member St ates, as provided for by Article 100a of 
the Treaty, may take provisional measures to limit or prohibit the placing on the 
market, putting into service a nd use of pressure equipment in cases where it presents 
a partic ular risk to the safety of persons a nd, where appropriate, domestic animals or 
property, provided that the measures are s ubject to a Community control procedure;  
 
Ø new 
(47) Regulation (EU) No […/…] [on market  surveillance of products] providing for a 
single Union legal instrument relating to ma rket surveillance of products, applies to 
pressure equipment. 
 
Ð 97/23/EC recital 24  
Whereas the addressees of any decision taken unde r this Directive must be aware of 
the reasons behind that decision and the means of appeal open to them;  
 
Ð 97/23/EC recital 25 
Whereas it is necessary to  lay down a transitional a rrangement enabling pressure 
equipment manufactured in compliance with  the national regulati ons in force on the 
date of entry into force of this Directive to be marketed and put into service;  
 
Ð 97/23/EC recital 26  
Whereas the requirements laid down in the Annexes should be made as clear as 
possible so as to allow all us ers, including small and medium -sized enterprises 
(SMEs), to comply with them easily;  
 
Ð 97/23/EC recital 27 
Whereas an agreement on a modus vivendi  between the European Parliament, the 
Council and the Commission concerning the im plementing measures for acts adopted 
in accord ance with the procedure laid down in Article 189b of the Treaty was 
reached on 20 December 199426; 
                                                 
26 OJ No C 102, 4. 4. 1996, p. 1.  EN 27   EN  
Ø new 
(48) 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 of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers27.  
(49) The advisory procedure should be used for the adoption of implementing acts 
requesting the notifying Member State to ta ke the necessary corrective measures in 
respect of notified bodies that  do not meet or no longer meet  the requirements for their 
notification. 
(50) The examination procedure should be used  for the adoption of implementing acts with 
respect to European approvals for mate rials presenting shortcomings and whose 
references were already published in the Official Journal of  the European Union , 
given that such decisions could have cons equences on the presum ption of conformity 
with the applicable essential requirements. 
(51) In order to take into account the tec hnical developments in pressure equipment 
technology, the power to adopt acts in accordance with Article 290 of the Treaty 
should be delegated to the Co mmission in respect of amendments to classification of 
pressure equipment. It is of particul ar importance that the Commission carry out 
appropriate consultations dur ing its preparatory work, in cluding at expert level. 
(52) The Commission, when preparing and dr awing-up delegated act s, should ensure a 
simultaneous, timely and appropriate transm ission of relevant documents to the 
European Parliament and to the Council. 
(53) Directive 97/23/EC provides for a tr ansitional arrangement enabling pressure 
equipment and assemblies which comply with the national regulations in force on the 
date of application of Direc tive 97/23/EC to be put into service. For reasons of legal 
certainty, it is necessary to include that tran sitional arrangement also in this Directive. 
(54) It is necessary to provide for transiti onal arrangements that allow the making available 
on the market and the putting into service of  pressure equipment which complies with 
Directive 97/23/EC. 
(55) Member States should lay down rules on pe nalties applicable to infringements of the 
provisions of national law adopted pursuant to this Directive and ensure that they are 
implemented. Those penalties must be e ffective, proportionate and dissuasive. 
(56) Since the objective of this  Directive, namely to ensure that pressure equipment on the 
market fulfils the requirements providing a high level of protection of health and 
safety of users and protection of domestic animals or property while guaranteeing the 
functioning of the internal market cannot be sufficiently achieved by the Member 
States and can therefore, by reason of its scal e and effects, be better achieved at Union 
                                                 
27 OJ L 55, 28.2.2011, p. 13. EN 28   EN 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 orde r to achieve that objective. 
(57) The obligation to transpose this Directive into national law should be confined to those 
provisions which represent a substantive change as compared with Directive 
97/23/EC. The obligation to transpose the provisions wh ich are unchanged arises 
under Directive 97/23/EC. 
(58) This Directive should be without prejudice to the obliga tions of the Member States 
relating to the time-limits for transposition into national law and application of 
Directive 97/23/EC set out in Part B of Annex V, 
 
Ð 97/23/EC (adapted) 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER 1  
⌦ GENERAL PROVISIONS ⌫ 
Article 1 
Scope and definitions  
1. This Directive applies  ⌦ shall apply ⌫ to the design, manufacture and conformity 
assessment of pressure equipment and assemb lies with a maximum allowable pressure PS 
greater than 0,5 bar. 
32. The  following are exclu ded from the scope of  Tthis Directive ⌦ shall not apply to ⌫ : 
 
Ð 97/23/EC (adapted) 
3.1.(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) star ting from and including 
the last isolation device located within the confines of the installation, including all the 
annexed equipment designed specifically for pipelines;,  Tthis exclusion does  ⌦ shall ⌫ not 
apply to standard pressure equipment such as may be found in pressure  reduction stations or 
compression stations; 
3.2.(b) networks for the supply, distribution and di scharge of water and associated equipment 
and headraces such as penstocks, pressure  tunnels, pressure sh afts for hydroelectric 
installations and their re lated specific accessories; EN 29   EN  
Ð 97/23/EC (adapted) 
3.3.(c) equipment  ⌦ simple pressure vessels ⌫ covered by Directive 87/404/EEC  
2009/105/EC of the European Pa rliament and of the Council28 on simple pressure vessels ; 
3.4.(d) equipment  ⌦ aerosol dispensers ⌫ covered by Council Directive 75/324/EEC29 of 
20 May 1975 on the approximation of the laws of  the Member States relating to aerosol 
dispensers ; 
3.5.(e) equipment intended for the functioning of ve hicles defined by the following Directives 
and their Annexes : 
 
Ð 97/23/EC (adapted) 
(i) Directive 70/156/EEC of 6 February 1970  2007/46/EC of the European 
Parliament and of the Council30 on the approximation of the laws of the 
Member States relati ng to the type -approval of motor vehicl es and their trailers  
establishing a framework for the approval of motor vehicles and their trailers, 
and of systems, components and sepa rate technical units intended for such  
vehicles, ; 
(ii) Directive 74/150/EEC  2003/37/EC  of the European Parliament and of the 
Council31 4 March 1974  on the approximation of the laws of the Member 
States relating to the  type-approval of wheeled  agricultural or forestry tractors,  
their trailers and intercha ngeable towed machinery, together with their systems, 
components and separate technical units, ; 
(iii) Directive 92/61/EEC  2002/24/EC  of the European Parliament and of the 
Council32 30 June 1992  relating to the type-appr oval of two or three-wheel 
motor vehicles; 
3.6.(f) equipment classified as no higher than categ ory I under Article 9 of  this Directive and 
covered by one of the following Directives: 
(i) Directive 89/392/EEC  2006/42/EC  of the European Parliament and of the 
Council33 14 June 1989  on the approximation of the laws of the Member States 
relating to  machinery, ; 
                                                 
28 OJ L 264, 8.10.2009, p. 12 .  
29 OJ L 147, 9.6.1975, p. 40. Directive as las t amended by Commission Directive 94/1/EC (OJ No L 23, 
28. 1. 1994, p. 28).  
30 OJ L 263, 9.10.2007, p. 1.  OJ No L 42, 23. 2. 1970, p. 1. Directive as last amended by Commission 
Directive 95/54/EC (OJ No L 266, 8. 11. 1995, p. 1).  
31 OJ L 171, 9.7.2003, p. 1.  OJ No L 84, 28. 3. 1974, p. 10. Directive as last amended by the 1994 Act of 
Accession.  
32 OJ L 124, 9.5.2002, p. 1.  OJ No L 225, 10. 8. 1992, p. 72. Directive as last amended by the 1994 Act of 
Accession.  
33 OJ L 157, 9.6.2006, p. 24.  OJ No L 183, 29. 6. 1989, p. 9. Directive as last amended by Directive 
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).  EN 30   EN (ii) Directive 95/16/EC of 29 June 1995  the European Parliament and of the 
Council34 on the approximation of the laws of the Member States relating to  
lifts,; 
(iii) Directive 73/23/EEC  2006/95/EC  of the European Parliament and of the 
Council35 19 February 1973 on the harmoni sation of the laws of the Member 
States  relating to electrical equipment designed for use within certain voltage 
limits, ; 
(iv) Council Directive 93/42 /EEC of 14 June 1993  concerning medical devices36,; 
(v) Directive 90/396/EEC  2009/142/EC  of the European Parliament and of the 
Council37 29 June 1990  on the approximation of the laws of the Member States  
relating to appliances burning gaseous fuels, ; 
(vi) Directive 94/9/EC of the European Parliament and of the Council38 of 23 
March 1994 on the approximation of the laws of the Memb er States  concerning 
equipment and protective systems inte nded for use in potentially explosive 
atmospheres; 
3.7.(g) equipment covered by Article 223  ⌦ 346 ⌫ (1) (b) of the Treaty; 
3.8.(h) items specifically designed for nuclear use,  failure of which may cause an emission of 
radioactivity; 
3.9.(i) well-control equipment used in the petrol eum, gas or geotherm al exploration and 
extraction industry and in underground storage wh ich is intended to contain and/or control 
well pressure;,  Tthis ⌦ shall ⌫ comprises  the wellhead (Christmas tree), the blow out 
preventers (BOP), the piping manifold s and all their equipment upstream; 
3.10. (j) equipment comprising casings or mach inery where the dimensioning, choice of 
material and manufacturing rule s are based primarily on requirem ents for sufficient strength, 
rigidity and stability to meet the static a nd dynamic operational effects or other operational 
characteristics and for which pressure  is not a significant design factor;,  Ssuch equipment may 
include: 
(i) engines including turbines and internal combustion engines; 
(ii) steam engines, gas/steam turbines, tu rbo-generators, compressors, pumps and 
actuating devices; . 
3.11. (k) blast furnaces including the furnace coo ling system, hot-blast recuperators, dust 
extractors and blast-furnace exhaust-gas scrubb ers and direct reducing cupolas, including the 
                                                 
34 OJ L 213, 7.9.1995, p. 1. 
35 OJ L 374, 27.12.2006, p. 10.  OJ No L 77, 26.3.1973, p. 29. Directive  as last amended by Directive 
93/68/EEC (OJ No L 220, 30. 8. 19 93, p. 1).  
36 OJ L 169, 12.7.1993, p. 1. 
37 OJ L 330, 16.12.2009, p. 10.  OJ N o L 196, 26.7.1990, p. 15. Directive  as last amended by Directive 
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).  
38 OJ L 100, 19.4.1994, p. 1. EN 31   EN furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of 
steel and non-ferrous metals; 
3.12. (l) enclosures for high-voltage electrical e quipment such as switchgear, control gear, 
transformers, and rotating machines; 
3.13. (m) pressurized pipes for the containment of  transmission systems, e.g. for electrical 
power and telephone cables; 
3.14. (n) ships, rockets, aircraft and mobile off-s hore units, as well as equipment specifically 
intended for installation on board  or the propulsion thereof; 
3.15. (o) pressure equipment consisting of a flexible  casing, e.g. tyres, air cushions, balls used 
for play, inflatable craft, and other similar pressure equipment; 
3.16. (p) exhaust and inlet silencers; 
3.17. (q) bottles or cans for carbonated drinks for final consumption; 
3.18. (r)vessels designed for the transport and distri bution of drinks havi ng a PS·V of not more 
than 500 bar·L and a maximum allowable pressure not exceeding 7 bar; 
 
Ð 97/23/EC (adapted) 
3.19. (s) equipment covered by ⌦ Directive 2008/68/EC and  Directive 2010/35/EU and 
equipment covered by ⌫ ADR39, the RID40, the ⌦ International Maritime Dangerous Goods 
Code ⌫ (IMDG)41 and the ⌦ Convention on International Civil Aviation ⌫ (ICAO 
Convention)42; 
 
Ð 97/23/EC 
3.20. (t) radiators and pipes in wa rm water heating systems; 
3.21. (u) vessels designed to contain liquids with a gas pressure above the liquid of not more 
than 0,5 bar. 
 
Ð 97/23/EC (adapted) 
Article 2  
⌦ Definitions  ⌫ 
For the purposes of this Directive ⌦ the following definitions apply ⌫ : 
                                                 
39 ADR  = European Agreement concerning the International Carriage of Dangerous Goods by Road.  
40 RID  = Regulations concerning the International Carriage of Dangerous Goods by Rail.  
41 IMDG  = International Maritime Dangerous Goods Code.  
42 ICAO  = International Civil Aviation Organization.  EN 32   EN 2.1.(1) ‘Ppressure equipment’ means vessels, pi ping, safety accessories and pressure 
accessories. , ⌦ including, ⌫ Wwhere applicable, pressure equipment includes  elements 
attached to pressurized parts, such as fl anges, nozzles, couplings , supports, lifting lugs, etc.; 
 
Ð 97/23/EC 
2.1.1. (2) ‘Vvessel’ means a housing designed and built  to contain fluids under pressure 
including its direct a ttachments up to the coupling point connecting it to other equipment;,  Aa 
vessel may be composed of more than one chamber. ; 
2.1.2. (3) ‘Ppiping’ means piping components intended for the transport of fluids, when 
connected together for integration into a pressure system;,  Ppiping includes in particular a 
pipe or system of pipes, tubing, fittings, e xpansion joints, hoses, or other pressure-bearing 
components as appropriate;,  Hheat exchangers consisting of pi pes for the purpose of cooling 
or heating air shall be  considered as piping. ; 
 
Ð 97/23/EC (adapted) 
2.1.3. (4) ‘Ssafety accessories’ means devices designed to protect pressure equipment against 
the allowable limits being exceeded. , Such dev ices include  ⌦ 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 provi de for shutdown or shutdown and lockout, such as pressure 
switches or temperature switches or fluid le vel switches and «safety related measurement 
control and regulation (SRMCR)» devices. ; 
 
Ð 97/23/EC 
2.1.4. (5) ‘Ppressure accessories’ means devices with  an operational function and having 
pressure-bearing housings. ; 
2.1.5. (6) ‘Aassemblies’ means several pieces of pressure equipment assembled by a 
manufacturer to constitute an integrated and functional whole. ; 
2.2.(7) ‘Ppressure» means pressure relative to atmosphe ric pressure, i.e. ga uge pressure. As a 
consequence, vacuum is desi gnated by a negative value. ; 
2.3.(8) ‘Mmaximum allowable pressure PS’ means the maximum pressure for which the 
equipment is designed, as sp ecified by the manufacturer. , 
 
Ð 97/23/EC (adapted) 
It is ⌦ and ⌫ defined at a location sp ecified by the manufacturer  ⌦ him, being either ⌫ . 
This must be the location of  ⌦ the ⌫ connection of protective and/or limiting devices,  or 
the top of equipment or,  if not appropriate,  any point specified. 
 
Ð 97/23/EC 
2.4.(9) ‘Mmaximum/minimum allowable temperature TS’ means the maximum/minimum 
temperatures for which the equipment is designed, as specified by the manufacturer. ; EN 33   EN 2.5.(10) ‘Vvolume (V)’ means the internal volume of a chamber, including the volume of 
nozzles to the first connection or weld and excl uding the volume of pe rmanent internal parts. ; 
2.6.(11) ‘Nnominal size (DN)’ means a numerical desi gnation of size whic h is common to all 
components in a piping system other than co mponents indicated by outsi de diameters or by 
thread size;,  Iit is a convenient round number for refe rence purposes and is only loosely 
related to manufacturing dimensions;,  Tthe nominal size is designated by DN followed by a 
number. ; 
2.7.(12) ‘Ffluids’ means gases, liquids and vapours in pure phase as well as mixtures thereof. 
A fluid may contain a suspension of solids. ; 
2.8.(13) ‘Ppermanent joints’ means joints which ca nnot be disconnected except by destructive 
methods. ; 
2.9.(14) ‘European approval for materials’ m eans 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.
; 
 
Ø new 
(15) ‘making available on the market’ m eans any supply of pressure equipment for 
distribution or use on the Union market in the course of a commercial activity, whether in 
return for payment or free of charge; 
(16) ‘placing on the market’ means the first making available of pressure equipment on the 
Union market; 
(17) ‘manufacturer’ means any natural or  legal person who manufactures pressure 
equipment or has such equipment designed or  manufactured, and markets that product under 
his name or trademark; 
(18) ‘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; 
(19) ‘importer’ means any natural or legal pe rson established within the Union who places 
pressure equipment from a third country on the Union market; 
(20) ‘distributor’ means any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes pr essure equipment available on the market; 
(21) ‘economic operators’ means the manufact urer, the authorised representative, the 
importer and the distributor; 
(22) ‘technical specification’ m eans a document that prescribes technical requirements to 
be fulfilled by pressure equipment, process or service; 
(23) ‘harmonised standard’ means harmonised st andard as defined in  Article 2(1)(c) of 
Regulation (EU) No 1025/2012; EN 34   EN (24) ‘accreditation’ means accreditation as defi ned in Article 2(10) of Regulation (EC) No 
765/2008; 
(25) ‘national accreditation body’ means national accreditati on body as defined in Article 
2(11) of Regulation (EC) No 765/2008; 
(26) ‘conformity assessment’ means the pro cess demonstrating whether the requirements 
of this Directive relating to pressure equipmen t, process, service, or a system have been 
fulfilled; 
(27) ‘conformity assessment body’ means a body that performs conformity assessment 
activities including calib ration, testing, certification and inspection; 
(28) ‘recall’ means any measure aimed at achie ving the return of pre ssure equipment that 
has already been made available to the user; 
(29) ‘withdrawal’ means any measure aimed at preventing pressure equipment in the 
supply chain from being made available on the market; 
(30) ‘CE marking’ means a marking by which th e manufacturer indicate s that the pressure 
equipment and/or the assembly is in conformity with the applicable requirements set out in 
Union harmonisation legislation providing for its affixing; 
(31) ‘Union harmonisation legi slation’ means any Union legislation harmonising the 
conditions for the marketing of products. 
 
Ð 97/23/EC (adapted) 
Ö new 
Article 2 3 
Market surveillance  ⌦ Making available on the mark et and putting into service ⌫ 
1. Member States shall take all appropr iate measures to ensure that the  pressure equipment 
and the assemblies referred to in Article 1  may be placed  Ö made available  on the market 
and put into service only if,  when properly installed and maintained and used for their 
intended purpose, they do not endanger the h ealth and safety of persons and, where 
appropriate, domestic animals or property  Ö they satisfy the requirements of this Directive  
. 
2. The provisions of  Tthis Directive shall not affect Member  States' entitlement to lay down, 
with due regard to the provisions of the Treaty,  such requirements as they may deem 
necessary to ensure that pers ons and, in particular, workers are protected during use of the 
pressure equipment or assemblies  in question provided that th is does not mean modifications 
to such equipment or assemblies  in a way not specified in this Directive. 
3. At trade fairs, exhibitions, demonstrations, etc.,  ⌦ and other similar events, ⌫ Member 
States shall not prevent the show ing of pressure equipment or as semblies as defined in Article 
1 not in conformity  ⌦ which do not comply ⌫ with the provisions of  this Directive, 
provided that a visible sign clea rly indicates their non-conform ity and their non-availability EN 35   EN for sale until ⌦ they are ⌫ brought into conformity by the manufacturer or by his 
authorized representative established within the Community . During demonstrations, 
appropriate safety measures shall be taken in accordance with any re quirements laid down by 
the competent authority of the Member State c oncerned in order to ensure the safety of 
persons. 
Article 3 4 
Technical requirements 
1. The ⌦ following ⌫ pressure equipment refe rred to in 1.1, 1.2, 1.3 and 1.4  must satisfy 
the essential ⌦ safety ⌫ requirements set out in Annex I: 
 
Ð 97/23/EC 
Î1 Corrigendum 97/23/EC 
1.1.(a) Vvessels, except those referred to in 1.2  point (b)  for: 
(ai) gases, liquefied gases, gases dissolved  under pressure, vapours and also those 
liquids whose vapour pressure at th e maximum allowable temperature is 
greater than 0,5 bar above normal atmo spheric pressure, (1013 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 1000 
bar, and all portable extinguishers and bottles for breathing apparatus (Annex II, table 2); 
(b
ii) liquids having a vapour pressure at th e maximum allowable temperature of not 
more than 0,5 bar above normal atmos pheric pressure (1013 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 10000 bar·L, or  with a pressure PS greater than 
1000 bar (Annex II, table 4). 
1.2.(b) Ffired or otherwise heated pressure equipm ent with the risk of overheating intended 
for generation of steam or super-heate d water at temperatures higher than 
Î1 110 °C  having a volume greater than 2 L, and a ll pressure cookers (Annex II, table 5). 
1.3.(c) Ppiping intended for: EN 36   EN (ai) gases, liquefied gases, gases disso lved under pressure, vapours and those 
liquids whose vapour pressure at th e maximum allowable temperature is 
greater than 0,5 bar above normal atmosphe ric pressure (1013 mbar) within the 
following limits: 
– for fluids in Group 1 with a DN gr eater than 25 (Annex II, table 6), ; 
– for fluids in Group 2 with a DN gr eater than 32 and a product of PS and 
DN greater than 1000 bar (Annex II, table 7); 
(bii) liquids having a vapour pressure at th e maximum allowable temperature of not 
more than 0,5 bar above normal atmospheric pressure (1013 mbar), within the following limits: 
– for fluids in Group 1 with a DN gr eater than 25 and a product of PS and 
DN greater than 2000 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 5000 bar (Annex II, table 9). 
 
Ð 97/23/EC (adapted) 
1.4.(d) Ssafety and pressure accesso ries intended for equipment covered by 1.1, 1.2 and 1.3  
subparagraphs (a), (b), and (c)  including where such equipment is incorporated into an 
assembly. 
2. The ⌦ following ⌫ assemblies defined in Article 1, s ection 2.1.5,  which include at least 
one item of pressure equipment covered by section  paragraph  1 of this Article and which are 
listed in 2.1, 2.2 and 2.3 of this Article  must satisfy the essential ⌦ safety ⌫ requirements 
set out in Annex I. 
 
Ð 97/23/EC 
Î1 Corrigendum 97/23/EC 
Ö new 
2.1.(a) Aassemblies intended for generating steam or superheated water at a temperature 
higher than Î1 110 °C  comprising at least one item of fi red or otherwise heated pressure 
equipment presenting a risk of overheating. 
2.2.(b) Aassemblies other than those referred to in 2.1  point (a) , if the manufacturer intends 
them to be placed  Ö made available  on the market and put into service as assemblies. 
 
Ð 97/23/EC (adapted) 
Ö new 
2.3. By way of derogation from the first subparagraph  introductory paragraph to this 
section , assemblies intended for generating warm wa ter at temperatures not greater than 
110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L must 
comply with the essential ⌦ safety ⌫ requirements referred to in points  2.10, 2.11, 3.4, 5 
(a) and 5 (d) of Annex I. EN 37   EN 3. Pressure equipment and/or assemblies  below or equal to the limits ⌦ set out ⌫ in 
sections 1.1, 1.2  points (a), (b) and (c) of paragraph 1 and in paragraph 2  and 1.3 and section 2  
respectively must  ⌦ 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/or 
assemblies  must be accompanied by adequate instructions for use and must bear markings to 
perm it identification of the manufactur er or of his authorized repr esentative established within 
the Community . Such equipment and/or assemblies must  ⌦ shall ⌫ not bear the CE 
marking referred to in Article 15 18. 
Article 4 5 
Free movement 
1. 1.1 . Member States shall not, on grounds of the hazards  ⌦ risks ⌫ due to pressure, 
prohibit, restrict or impede the placing  Ö making available  on the market or ⌦ the ⌫ 
putting into service under the cond itions specified by the manufacturer of pressure equipment 
or assemblies referred to in Article 1  which comply with this Directive and bear the CE 
marking indicating that they have  undergone conformity assessment i n accordance with 
Article 10 . 
1.2. Member States shall not, on grounds of the hazards  ⌦ risks ⌫ due to pressure, 
prohibit, restrict or impede the placing  Ö making available  on the market or ⌦ the ⌫ 
putting into service of pressure equipment or assemblies  which comply with Article 3 4(3). 
2. 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 Annex I  sections  points  3.3 
and 3.4 of Annex I  to be provided in the offici al language(s) of the Community  ⌦ Union ⌫ 
which may be determined in accordance with the  Treaty  by the Member State in which the 
equipment or assembly  reaches the final  user. 
14.2.3. When a Member State has designated a user inspectorate in accordance with the 
criteria  ⌦ requirements ⌫ set out in this  Article Ö 25  , it may not, on grounds of the 
hazards  ⌦ risks ⌫ due to pressure, prohibit, restrict or  impede the placing on the market or 
putting into service under the c onditions provided for in this  Article 16 , of pressure equipment 
or assemblies  the conformity of which has been assesse d by a user inspectorate designated by 
another Member State in accordance with the criteria  ⌦ requirements ⌫ set out in this  
Article Ö 25  . EN 38   EN  
Ø new 
CHAPTER 2 
OBLIGATIONS OF ECONOMIC OPERATORS 
Article 6 [Article R2 of Decision No 768/2008/EC] 
Obligations of manufacturers 
1. When placing their pressure equipment refe rred to in Article 4(1) and (2) on the 
market, 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 referred to in Article 4(3) on the market, 
manufacturers shall ensure that they have been  designed and manufactured in accordance with 
the sound engineering practice of a Member State. 
2. For pressure equipment referred to in Artic le 4(1) and (2), manufacturers shall draw 
up the technical documentation referred to in  Annex II and carry out the conformity 
assessment procedure referred to in Article 14 or have it carried out. 
Where compliance of pressure equipment referre d to in Article 4(1) and (2), with the 
applicable requirements has been demonstrated by the procedure referred to in the first 
subparagraph,  manufacturers shall draw up an EU declar ation of conformity and affix the CE 
marking. 
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity for 10 years after the pressure equipment has been placed on the market. 
4. Manufacturers shall ensure that procedures are in place for series production to remain 
in conformity. Changes in pressure equipment design or characteristics and changes in the 
harmonised standards or in othe r technical specifications by refe rence to which conformity of 
pressure equipment is declared shal l be adequately taken into account.   
When deemed appropriate with regard to th e risks presented by pressure equipment, 
manufacturers shall, to protect the health and safety of consum ers and other users, carry out 
sample testing of pressure equipment made av ailable on the market, investigate, and, if 
necessary, keep a register of complaints of non-conforming pressure eq uipment and recalls of 
such equipment, and shall keep distri butors informed of any such monitoring. 
5. Manufacturers shall ensure that their pressu re equipment bear a type, batch or serial 
number or other element allowi ng their identification, or, wher e the size or nature of the 
equipment does not allow it,  that the required information is provided on the pa ckaging or in a 
document accompanying the equipment. EN 39   EN 6. Manufacturers shall indicate their name, regi stered trade name or registered trade 
mark, the postal address, and, if available, the website address at which they can be contacted 
on the pressure equipment or, where that is not  possible, on their packaging or in a document 
accompanying the equipment. The address must  indicate a single point at which the 
manufacturer can be contacted. 
7. Manufacturers shall ensure that the pressure equipment 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, understandab le and intelligible. 
Manufacturers shall ensure that the pressure equipment referred to in Article 4(3), is 
accompanied by instructions and safety informa tion in accordance with Article 4(3), in a 
language which can be easily understood by consum ers 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 the pressure equipment 
which they have placed on the market is not in conformity with this Directive shall 
immediately take the necessary  corrective measures necessary to bring that pressure 
equipment into conformity, to withdraw it or r ecall it, if appropriate. Furthermore, where the 
pressure equipment presents a risk, manufactur ers shall immediately inform the competent 
national authorities of the Member States in  which they made the pressure equipment 
available on the market to that effect, giving details, in particular, of the noncompliance 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 do cumentation necessary to demonstrate the 
conformity of the pressure equi pment 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 eq uipment which they have placed on the market.  
Article 7 [Article R3 of Decision No 768/2008/EC] 
Authorised representatives 
1. A manufacturer may, by a written mandate, appoint an authorised representative. 
The obligations laid down in Article 6(1) and the drawing up of technical documentation shall 
not form part of the author ised representative's mandate. 
2. An authorised representative shall perform the tasks specified in the mandate received 
from the manufacturer. The mandate shall allow th e authorised representative to do at least 
the following: 
(a) keep the EU declaration of conform ity and the technical documentation at the 
disposal of national surv eillance authorities for 10 years after the pressure 
equipment has been placed on the market; EN 40   EN (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; 
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks posed by pressure equipment covered by the 
authorised representative’s mandate. 
Article 8 [Article R4 of Decision No 768/2008/EC] 
Obligations of importers 
1. Importers shall place only compliant pressure equipment on the market. 
2. Before placing on the market pressure equipm ent 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 sh all ensure that the 
manufacturer has drawn up the te chnical documentation, that the pressure equipment bears the 
CE marking and is accompanied by instructions and safety information in accordance with 
points 3.3 and 3.4 of Annex I, a nd that the manufacturer has co mplied with the requirements 
set out in Article 6(5) and (6). 
Before placing on the market pressure equipment referred to in Article 4(3), importers shall 
ensure that the manufacturer has drawn up the technical documen tation and that the pressure 
equipment is accompanied by adequate instruct ions 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 pressure equipment is not in 
conformity with the essential safety requiremen ts set out in Annex I, he shall not place the 
pressure equipment on the market until it has been brought into conformity. Furthermore, 
where the pressure equipment presents a risk, the importer shall inform the manufacturer and 
the market surveillance aut horities to that effect. 
3. Importers shall indicate their name, register ed trade name or regi stered trade mark and 
the postal address at which they can be contacted  on the pressure equipment or, where that is 
not possible, on its packaging or in a docum ent accompanying the equipment. The contact 
details shall be in a language  easily understood by users and mark et surveillance authorities. 
4. Importers shall ensure that pressure equipm ent referred to in Ar ticle 4(1) and (2) is 
accompanied by instructions and safety inform ation in accordance with points 3.3 and 3.4 of 
Annex I, in a language which can be easily un derstood by consumers and other users, as 
determined by the Member State concerned. 
Importers shall ensure that the pressure equipm ent 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 determ ined by the Member State concerned. 
5. Importers shall ensure that, while pressure equipment referred to in Article 4(1) and 
(2) is under their responsibility, storage or  transport conditions do not jeopardise its 
compliance with the requirements set out in Annex I. EN 41   EN 6. When deemed appropriate with regard to the risks presented by pressure equipment, 
importers shall, to protect the health and sa fety of consumers and other users, upon a duly 
justified request of the competent authorities, carry out sample testing of pressure equipment 
made available on the market, investigate, and, if necessary, keep a register of complaints, 
non-conforming pressure equipment 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 which they 
have placed on the market is not  in conformity with  this Directive shal l immediately take the 
corrective measures necessary to bring that pressure equipment into conformity, to withdraw 
it or recall it, if appropriate.  Furthermore, where the pressu re equipment presents a risk, 
importers shall immediately inform the competent national authorities of the Member States 
in which they made the pressure equipment av ailable on the market to  that effect, giving 
details, in particular, of the noncomplia nce and of any corrective measures taken. 
8. Importers shall, for 10 years after the pressure equipment has been placed on the 
market, keep a copy of the EU declaration of conformity at the dis posal of the market 
surveillance authorities and ensure that the te chnical 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 do cumentation necessary to demonstrate the 
conformity of pressure equi pment in a language which can be easily understood by that 
authority. That information and documentation ma y 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 whic h they have placed on the market.  
Article 9 [Article R5 of Decision No 768/2008/EC] 
Obligations of distributors 
1. When making pressure equipment available on the market distributors shall act with 
due care in relation to the requi rements of this Directive. 
2. Before making pressure equipment referred to  in Article 4(1) and (2) available on the 
market distributors shall verify that the pressure equipment bear s 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 Stat e in which the pressure equipment is to be 
made available on the market, and that the ma nufacturer and the importer have complied with 
the requirements set out in Article  6(5) and (6) and Article 8(3). 
Where a distributor considers or has reason to believe that pressure equipment is not in 
conformity with the essential safety requirement s set out in Annex I, he shall not make the 
pressure equipment available on the market until it has been brought into conformity. 
Furthermore, where the pressure equipment presents a risk, the distributor shall inform the 
manufacturer or the importer to that effect as well as the ma rket surveillance authorities. 
Before making pressure equipment referred to  in Article 4(3) available on the market 
distributors shall verify that th e pressure equipment is accomp anied by adequate instructions EN 42   EN for use, in a language which can be easily understood by consumers and other users in the 
Member State in which the pressure equipment is to be made available on  the market, and that 
the manufacturer and the importer have complied w ith the requirements set out in Article 6(5) 
and (6) and Article 8(3). 
3. Distributors shall ensure that, while pressure  equipment referred to in Article 4(1) and 
(2) is under their responsibility, storage or tr ansport conditions do not jeopardise their/its 
compliance with the essential safety  requirements set out in Annex I. 
4. Distributors who consider or have reason to believe that pressure equipment which 
they have made available on the market is not in conformity with this Directive shall make 
sure that the corrective measures necessary to  bring that equipment into conformity, to 
withdraw it or recall it, if appropriate, are taken. Furthermor e, where the pressure equipment 
presents a risk, distributors shal l immediately inform the competent national authorities of the 
Member States in which they made the equipmen t available 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 do cumentation necessary to demonstrate the 
conformity of pressure equipment. That info rmation and documentation may be provided in 
paper or electronic form. They shall cooperate with that authority, at it s request, on any action 
taken to eliminate the risks posed by the pressu re equipment which they have made available 
on the market.  
Article 10 [Article R6 of Decision No 768/2008/EC] 
Cases in which obligations of manufactu rers apply to importers and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subjec t to the obligations of the ma nufacturer under Article 6, where 
he places pressure equipment on the market under his name or trademark or modifies pressure 
equipment already placed on the market in such  a way that compliance with the requirements 
of this Directive may be affected. 
Article 11 [Article R7 of Decision No 768/2008/EC] 
Identification of economic operators 
Economic operators shall, on request, identify the following to the market surveillance 
authorities, for 10 years: 
(a) any economic operator who has supp lied them with pressure equipment; 
(b) any economic operator to whom they  have supplied pressure equipment. 
Economic operators shall be able to present the information refe rred to in the first paragraph 
for a period of 10 years after they have been supplied with the pressure equipment and for a 
period of 10 years after they have  supplied the pressure equipment.  EN 43   EN CHAPTER 3 
CONFORMITY AND CLASSIFICATION OF PRESSURE 
EQUIPMENT  
 
Ð 97/23/EC 
Article 5 12 [Article R8 of Decision No 768/2008/EC] 
Presumption of conformity 
 
Ø new 
1. Pressure equipment re ferred to in Article 4(1) and (2) which are in conformity with 
harmonised standards or parts thereof the refe rences 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 st andards or parts thereof,  referred to in Annex 
I.  
 
Ð 97/23/EC (adapted) 
1.2. Member States shall regard pressure equipment and assemblies  bearing the CE marking 
provided for in Article 15 18 and the EC  ⌦ EU ⌫ declaration of conformity provided for in 
Annex V II Article 17  as conforming to all the provisions of  this Directive, including the 
conformity assessment provided for in Article 10 . 
 
Ð 97/23/EC 
2. Press ure equipment and assemblies which confor m to the national standards transposing 
the harmonized standards the reference numbers of  which have been published in the Official 
Journal of the European Communities shall be presumed to conform to the essential 
requirements referred to in Article 3. Member States shall publish the reference numbers of 
the national standards referred to above.  
3. Member States shall ensure that appropriate  measures are taken to enable both sides of 
industry to have an input at nati onal level in the process of  preparing and monitoring the 
harmonized standards.  
 
Ð 97/23/EC (adapted) 
4.3. The materials used for the manufactur e of pressure equipment conforming  ⌦ which are 
in conformity ⌫ with European approvals for materials, the references of which have been 
published in the Official Journal of the European Communities  ⌦ Union  in accordance with 
Article 15(4), ⌫ shall be presumed to conform to  ⌦ be in conformity with ⌫ the 
applicable essential ⌦ safety ⌫ requirements of  ⌦ set out in ⌫ Annex I.  EN 44   EN Article 9 13 
Classification of pressure equipment 
1. Pressure equipment referred to in Article 3 4(1) shall be classified by category in 
accordance with Annex II, accordin g to ascending level of hazard  ⌦ risk ⌫ . 
For the purposes of such classifica tion fluids shall be divided into ⌦ the following ⌫ two 
groups:  in accordance with 2.1 and 2.2.  
 
Ð 97/23/EC 
2.1. Group 1 comprises dangerous fluids. A danger ous fluid is a substa nce or preparation 
covered by the definitions in Article 2 (2) of Council Directive 67/548/EEC of 27 June 1967 
on the approximation of the laws , regulations and administrativ e provisions relating to the 
classification, packaging and labelling of dangerous substances43. 
 Group 1 comprises fluids defined as:  
– explosive,  
– extremely flammable,  
– highly flammable,  
– flammable (where the maximum allowable temperature is above flashpoint),  
– very toxic,  
– toxic,  
– oxidizing.  
 
Ø new 
(a) group 1 that comprises fluids  consisting of substa nces 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 physi cal or health hazard classes laid down in Parts 2 and 3 of 
Annex I to that Regulation:  
(i) unstable explosives or explosiv es of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5; 
(ii) flammable gases, category 1 and 2; 
(iii) oxidising gases, category 1; 
(iv) flammable liquids, categories 1 and 2; 
                                                 
43 OJ No  196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 94/69/EC (OJ No L 
381, 31. 12. 1994, p. 1).  EN 45   EN (v) flammable liquids, category 3 where the maximum allowable temperature is 
above the flashpoint; 
(vi) flammable solids, category 1 and 2; 
(vii) self-reactive substances and mixtures, type A to F; 
(viii) pyrophoric liquids, category 1; 
(ix) pyrophoric solids, category 1; 
(x) substances and mixtures which in c ontact with water emit flammable gases, 
category 1, 2 and 3; 
(xi) oxidising liquids, category 1, 2 and 3; 
(xii) oxidising solids, category 1, 2 and 3; 
(xiii) organic peroxides types A to F; 
(xiv) acute oral toxicity: category 1 and 2; 
(xv) acute dermal toxicity: category 1 and 2; 
(xvi) acute inhalation toxi city: category 1, 2 and 3; 
(xvii) specific target organ toxi city – single exposure: category 1. 
 
Ð 97/23/EC (adapted) 
2.2.(b) Ggroup 2 ⌦ that ⌫ comprises all other fluids  not referred to in 2.1  point (a) . 
 
Ð 97/23/EC 
3.2. Where a vessel is composed of  a number of chambers, it shall be classified in the highest 
category applicable to the individual chambe rs. Where a chamber contains several fluids, 
classification shall be on the basis of th e fluid which requires the highest category. 
 
Ð 97/23/EC (adapted) 
Article 10 14 
Conformity assessment 
1. 1.1. Before placing pressure equipment on th e market, the manufacturer shall subject 
each item of equipment to one of the conformi ty assessment procedures described in Annex 
III, according  to the conditions given in this Article.  
1.2.1. The conformity assessment procedures to be  applied to an item of pressure equipment 
with a view to affixing the CE marking  shall be determined by the category, as defined  ⌦ set 
out ⌫ in Article 9 13, in which the equipment is classified. EN 46   EN 1.3.2. The conformity assessment procedures to be  applied for the vari ous categories are as 
follows  ⌦ the following ⌫ : 
 
Ð 97/23/EC 
(a) category I:  
– Module A 
(b) category II:  
– Module A1 2 
– Module D1 
– Module E1 
(c) category III:  
 
Ð 97/23/EC (adapted) 
– Module B1  ⌦ (design type) ⌫ + D 
– Module B1  ⌦ (design type) ⌫ + F 
– Module B ⌦ (combination of producti on type and design type) ⌫ + E 
– Module B ⌦ (combination of producti on type and design type) ⌫ + C1 2 
 
Ð 97/23/EC 
– Module H 
(d) category IV:  
 
Ð 97/23/EC (adapted) 
– Module B ⌦ (combination of producti on type and design type) ⌫ + D 
– Module B ⌦ (combination of producti on type and design type) ⌫ + F 
 
Ð 97/23/EC (adapted) 
– Module G 
– Module H1 
⌦ The conformity assessment procedures are set out in Annex III. ⌫ 
1.4.3. Pressure equipment shall be subjected  to one of the conformity assessment procedures 
which may be chosen by the manufacturer among those laid down for the category in which it EN 47   EN is classified. The manuf acturer may also choose to apply one of the procedures which apply to 
a higher category, if available. 
1.5.4. In the framework of quality assurance procedures for ⌦ pressure ⌫ equipment in 
categories III and IV referred to in Article 3 4(1)(a)(i) , section 1.1 (a), section1  first indent of 
Article 4(1) (ba)(ii) and 3  Article 4(1)(b)  section 1.2 , the notified body shall, when performing 
unexpected visits, take a sample of equipment fr om the manufacturing or storage premises in 
order to perform, or have perfor med, the final assessment as refe rred to in Annex I, section  
point  3.2.2. To this end, the manufacturer sha ll inform the notified body of the intended 
schedule of production. The notified body shall carry  out at least two vi sits during the first 
year of manufacturing. The freque ncy of subsequent visits shall be determined by the notified 
body on the basis of the crit eria set out in section  point  4.4 of the relevant modules. 
1.6.5. In the case of one-off production of vessels and ⌦ pressure ⌫ equipment in 
Category III referred to in Article 3 4(1)(b), section 1.2  under the module H procedure, the 
notified body shall perform or ha ve performed the final assessm ent, as referred to in Anne x I, 
section  point  3.2.2 of Annex I , for each unit. To this end, the manufacturer shall communicate 
the intended schedule of pr oduction to the notified body. 
 
Ð 97/23/EC (adapted) 
2.6. Assemblies referred to in Article 3 4(2) shall be subjecte d to a global conformity 
assessment procedure comprising ⌦ the following assessments ⌫ : 
 
Ð 97/23/EC (adapted) 
Ö new 
(a) ⌦ the ⌫ assessment of each item of pressure equipment making up the assembly 
and referred to in Article 3 4(1) which has not been previous ly subjected to a conformit y 
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 th e various components of the assembly as 
referred to in section s 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 section s points  2.10 and 3.2.3 of Annex I shall be conducted 
in the light of the highest cat egory applicable to the items of equipment to be protected. 
3.7. By way of derogation from paragraphs 1 and 2, the competent authorities may, where 
justified, allow the placing  Ö 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 1 2(2), in respect of which the procedures referred to in 
paragraphs 1 and 2 of this Ar ticle have not been applied a nd the use of which is in the 
interests of experimentation. EN 48   EN  
Ð 97/23/EC (adapted) 
4. Records and correspondence re lating to conformity assessment shall be drawn up in the 
official language(s) of the Community  ⌦ Union ⌫ which may be determined in accordance 
with the Treaty  by the Member State where the body responsible for carrying out these 
procedures is established, or in a language accepted by that body. 
 
Ð 97/23/EC (adapted) 
Article 11 15 
European approval for materials 
1. European approval for materials, as defined in Article 1, section 2.9,  shall be issued at the 
request of one or more manufact urers of materials or equipment, by one of the notified bodies 
referred to in Article 12 20 specifically designated for that task. The notified body shall 
determine and perform, or arrange for the pe rformance of, the appropriate inspections and 
tests to certify the conformity of the types of material with the corresponding requirements of 
this Directive; . iIn the case of materials recogniz sed as being safe to use before 29 November 
1999, the notified body shall take account of the existing data when certifying such 
conformity. 
 
Ð 97/23/EC (adapted) 
Ö new 
2. Before issuing ⌦ a ⌫ European approval for materials, the notified body shall inform  
⌦ notify ⌫ the Member States and the Commission by sending them  the appropriate 
information. Within three months, a Member State or the Commission may refer the matter to 
the Standing Committee set up by Ar ticle 5 of Directive 83/189/EEC,  Ö provide 
comments  giving its reasons. In that  case, the Committee shall issue an opinion as a matter 
of urgency.  
The notified body shall  ⌦ may ⌫ issue the European approval for materials taking into 
account, where appropriate, the opinion of the Committee and  the comments submitted. 
 
Ð 97/23/EC (adapted) 
3. A copy of the European approval for pressure equipment  materials shall be sent to the 
Member States, the notified bodies and the Commission. 
 
Ð 97/23/EC (adapted) 
4. ⌦ When the European approval for materials satisfies the requirements which it covers 
and which are set out in Annex I, ⌫ tThe Commission shall publish ⌦ the references of that 
approval. ⌫ and  ⌦ The Commission shall ⌫ keep up to date a list of ⌦ such ⌫ 
European  approvals for mat erials  in the Official Journal of the European Communitie s 
⌦ Union  ⌫.  EN 49   EN  
Ð 97/23/EC (adapted) 
Î1 Corrigendum, OJ L 265, 
27.9.1997, p. 110 
5. The notified body which issued the European approval for pre ssure equipment  materials 
shall withdraw that approval if it finds that it should not have been Î1 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 Comm ission of any withdrawal of an approval. 
 
Ø new 
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 th e essential safety requirement s which it covers and which 
are set out in Annex I, the Commission shall decide by 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 shall be ad opted in accordance 
with the examination procedure referred to in Article 39(3).  
 
Ð 97/23/EC (adapted) 
Ö new 
Article 14 16 
User inspectorates 
1. By way of derogation from the provisions re lating to the tasks carried out by the notified 
bodies, Member States may authorize in  ⌦ on ⌫ their territory the placing  Ö making 
available  on the market, and the putting into servi ce by users, of pressure equipment or 
assemblies referred to in Article 1  of which conformity with the essential ⌦ safety ⌫ 
requirements has been assessed by a user in spectorate designated in accordance with the 
criteria referred to in  paragraph 8 7. 
 
Ð 97/23/EC (adapted) 
3.2. Pressure equipment and assemblies  the conformity of which has been assessed by a user 
inspectorate shall not bear the CE marking. 
 
Ð 97/23/EC (adapted) 
4.3. The pressure equipment and assemblies  referred to in paragraph 1  may be used only in 
establishments operated by the group of which th e inspectorate is part . The group shall apply 
a common safety policy as regards the technica l specifications for the design, manufacture, 
inspection, maintenance and use of pressure equipment and assemblies . EN 50   EN  
Ð 97/23/EC (adapted) 
54. The user inspectorates sha ll act exclusively for the group  of which they are part. 
65. The conformity assessment procedures appli cable by user inspectora tes shall be modules 
A12, C12, F and G, as described  ⌦ set out ⌫ in Annex III. 
 
Ð 97/23/EC (adapted) 
76. Member States shall inform  ⌦ notify ⌫ the other Member Stat es and the Commission 
which user inspectorates they ha ve authorised, the tasks for wh ich they have been designated 
and, for each inspectorate, a list of the establis hments satisfying the provisions of paragraph 
43. 
87. In designating the user inspectorates, the Member States shall apply the criteria l isted  
⌦ requirements set out ⌫ in Annex V  Article 25  and ensure that the group of which the 
inspectorate is part applies the criteria referr ed to in the second sentence of paragraph 4 3. 
 
Ð 97/23/EC 
9. A Member State that has author ized a user inspectorate shall w ithdraw that authorization if 
it finds that the user inspector ate no longer meets the criteria referred to in paragraph 8. It 
shall  inform the other Member Stat es and the Commission thereof.  
10. The effects of this Article shall be m onitored by the Commission and evaluated three 
years after the date specified in Article 20 (3). To th is end, Member States shall forward to the 
Commissio n any useful information on the implementa tion of this Article. If necessary the 
evaluation shall be accompanied by a propos al for amendment of the Directive.  
 
Ø new 
Article 17 [Article R10 of Decision No 768/2008/EC] 
EU declaration of conformity 
1. The EU declaration of conformity shall st ate that the fulfilment of essential safety 
requirements set out in Anne x I has been demonstrated. 
2. The EU declaration of conformity shall have  the model structure set out in Annex III and 
shall contain the elements specified in the rele vant conformity assessm ent procedures set out 
in Annex II 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 is placed or 
made available on the market. 
3. Where pressure equipment is subject to more than one Union act requiring an EU 
declaration of conformity, a single EU declaratio n of conformity shall be drawn up in respect 
of all such Union acts. That declaration shall contain the identification of the acts concerned 
including the publication references.  EN 51   EN 4. By drawing up the EU declaration of c onformity, the manufacturer shall assume 
responsibility for the compliance of the pressu re equipment with the requirements laid down 
in this Directive.  
Article 18  [Article R11 of Decision No 768/2008/EC] 
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. 
 
Ð 97/23/EC (adapted) 
Article 15 19 [Article R12 of Decision No 768/2008/EC] 
⌦ Rules and conditions for affixing the ⌫ CE marking 
 
Ð 97/23/EC 
1. The CE marking consists of the initials «C E» in accordance with the model in Annex VI . 
The CE marking shall be accompanied by the iden tification number, as re ferred to in Article 
12 (1), of the notified body involve d at the production control phase.  
 
Ð 97/23/EC (adapted) 
Ö new 
2.1. The CE marking shall be affixed in a vi sible, easily legible and indelible fashion  
⌦ visibly, legibly and indelibly ⌫ to ⌦ any of the following: ⌫ 
(a) each item of pressure equi pment referred to in Article 3 4(1), or  
(b) assembly referred to in Article 3 4(2).  
which is  ⌦ The item or assembly referred to in point s (a) and (b) of the first subparagraph 
shall be ⌫ complete or is  ⌦ shall be ⌫ in a state permitting final assessment as described 
in section  point  3.2 of Annex I Ö , or to its data plate. Wher e the affixing of the CE marking 
is not possible or not warranted on account of th e nature of the equipment or assembly, it shall 
be affixed to the packaging and to the accompanying documents . 
3.2. It is not necessary for the CE marking to be affixed to each individual item of pressure 
equipment making up an assembly as referred to in Article 3 (2) . Individual items of pressure 
equipment already bearing the CE marking wh en incorporated into the assembly shall 
continue to bear that marking. EN 52   EN  
Ð 97/23/EC 
4. Where the pressure equipment or assembly is  subject to other Dire ctives covering other 
aspects which provide for the affixing of the CE ma rking, the latter shall indicate that the 
pressure equipment or assembly in question is also presumed to conform to the provisions of 
those other Directives.  
However, should one or more of those Di rectives allow the ma nufacturer, during a 
transitional peri od, to choose which arrangem ents to apply, the CE marking shall indicate 
conformity only with the Directiv es applied by the ma nufacturer. In this case, the particulars 
of the said Directives, as published in the Official Journal of the European Communities , 
must be given in the documents, notices or instructions required by the Directives and 
accompanying the pressure equipment or assembly.  
5. The affixing of markings on pressure equipm ent or assemblies which are likely to mislead 
third parties as to the me aning or form of the CE marki ng shall be prohibited. Any other 
marking may be affixed to pressure equipment or assemblies provided that the visibility and 
legibility of the CE mark ing is not thereby reduced.  
 
Ø new 
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 iden tification number of the notified body, where 
that body is involved in the production control phase. 
The identification number of the notified body sh all 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 id entification number referre d to in paragraph 4 
may be followed by any other mark indicating a special risk or use. 
CHAPTER 4 
NOTIFICATION OF CONFORMI TY ASSESSMENT BODIES 
 
Ð 97/23/EC 
Article 12  
Notified bodies  
1. Member States shall notify the Commission a nd the other Member States of the bodies 
which they  have appointed to carry out the procedur es referred to in Article 10 and Article 11, 
together with the specific tasks which those bodi es have been appointed to carry out and the 
identification numbers assigned to them beforehand by the Commission.  EN 53   EN The Com mission shall publish in the Official Journal of the European Communities  a list of 
the notified bodies, with their id entification numbers and the tasks for which they have been 
notified. The Commission shall ensure that this list is kept up to date.  
2. Member States shall apply the criteria se t out in Annex IV for the designation of 
bodies. Bodies meeting the criteria laid down in  the relevant harmonized standards shall be 
presumed to fulfil the corres ponding criteria in Annex IV.  
3. A Member State which h as notified a body must withdraw such notification if it finds 
that the body no longer meets the crit eria referred to in paragraph 2.  
It shall forthwith inform the other Member  States and the Commission of any such 
withdrawal of a notification.  
Article 13  
Recognized third -party organizations  
1. Member States shall notify the Commission and the other Member States of the third -party 
organizations which they have recognized for th e purposes of the tasks referred to in Annex I, 
sections 3.2.2 and 3.1.3.  
The Co mmission shall publish in the Official Journal of the European Communities  a list of 
the recognized organizations with the task s for which they have been recognized. The 
Commission shall ensure that th is list is kept up to date.  
2. Member States shall appl y the criteria set out in Anne x IV for the recognition of 
organizations. Organizations meeting the crite ria laid down in the relevant harmonized 
standards shall be presumed to fulfil the corresponding crite ria in Annex IV.  
3. A Member State which has recog nized an organization must w ithdraw such recognition if it 
finds that the organization no longer meets the criteria re ferred to in paragraph 2.  
It shall forthwith inform the other Member  States and the Commission of any such 
withdrawal of a recognition.  
 
Ø new 
Article 20 [Article R13 of Decision No 768/2008/EC] 
Notification 
Member States shall notify the Commission and the other Member States of the notified 
bodies and the user inspectorates authorised to  carry out third-party conformity assessment 
tasks in accordance with Article 15, Artic le 16 or Annex III  and of the third-party 
organisations they have recognised, for the pur poses of the tasks referred to in points 3.1.2 
and 3.1.3 of Annex I.  EN 54   EN Article 21 [Article R14 of Decision No 768/2008/EC] 
Notifying authorities 
1. Member States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary proce dures for the assessment  and notification of 
conformity assessment bodies and the monitori ng of notified bodies, recognised third-party 
organisations and user inspectorates, including compliance with Article 26. 
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 para graph 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(1) to (6). In addition it sh all have arrangements to cover 
liabilities arising out of its activities. 
4. The notifying authority sha ll take full responsibility for the tasks performed by the 
body referred to in paragraph 3.  
Article 22 [Article R15 of Decision No 768/2008/EC] 
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 sa feguard 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 shal l 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 c onfidentiality of the information it obtains. 
6. A notifying authority shall have a sufficie nt number of competent personnel at its 
disposal for the proper performance of its tasks. EN 55   EN Article 23 [Article R16 of Decision No 768/2008/EC] 
Information obligation on  notifying authorities 
Member States shall inform the Commission of their proce dures for the assessment and 
notification of conformity assessment bodi es and the monitoring of notified bodies, 
recognised third-party organisa tions and user inspectorates, and of any changes thereto. 
The Commission shall make that information publicly available. 
Article 24 [Article R17 of Decision No 768/2008/EC] 
Requirements relating to notified bodies and recognised third-party organisations 
1. For the purposes of notification, a notifie d body or recognised thir d party organisation 
shall meet the requirements laid  down in paragraphs 2 to 11. 
2. A conformity assessment body shall be established under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body independent of the 
organisation or the pressu re equipment it assesses. 
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufactur ing, provision, assembly, use or maintenance 
of pressure equipment which it assesses, ma y, 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, installe r, purchaser, owner, user or maintainer of the pressure 
equipment which they assess, nor the representa tive of any of those parties. This shall not 
preclude the use of assessed pressure equipment 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 sh all not be directly involved in the design, 
manufacture or construction, the marketing, installation, use or maintenance of that pressure 
equipment, or represent the parties engaged in those activities. They shall not engage in any 
activity that may conflic t with their independence of judgeme nt or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 
Conformity assessment bodies sh all ensure that the activitie s of their subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities. 
5. Conformity assessment bodies and their pe rsonnel 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 EN 56   EN 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 15, Annex III or points 3.1.2 and 3.1.3 of Annex I 
and in relation to which it ha s been notified, whether thos e 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 assessm ent procedure and each  kind or category of 
pressure equipment in relation to which it ha s been notified, a conf ormity assessment body 
shall have at its disposal the necessary: 
(a) personnel with technical knowledge a nd sufficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accord ance with which conformity assessment is 
carried out, ensuring the transparency a nd the ability of reproduction of those 
procedures. It shall have appropriate policies and procedur es in place that 
distinguish between tasks it carries out  as a conformity assessement body and 
other activities; 
(c) procedures for the performance of activ ities 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. 
It 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 fo r carrying out conformity asse ssment activities shall have 
the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in rela tion to which the conform ity assessment body has been 
notified; 
(b) satisfactory knowledge of the requireme nts 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 harmoni sation 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 asse ssment bodies, their top level management and 
of the assessment pers onnel shall be guaranteed. EN 57   EN The remuneration of the top level management  and assessment personnel 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 la w, or the Member Stat e itself is directly 
responsible for the conformity assessment. 
10. The personnel of a conformity assessm ent body shall observe professional secrecy 
with regard to all information obtained in carrying out their tasks under Article 15, Annex III 
or under points 3.1.2 and 3.1.3 of Annex I or any provision of national la w giving effect to 
them, except in relation to the competent aut horities of the Member State in which its 
activities are carried out. Proprieta ry rights shall be protected. 
11. Conformity assessment bodies shall particip ate in, or ensure that their assessment 
personnel are informed of, the relevant standard isation activities and th e activities of the 
notified body coordination group establishe d under the relevant Union harmonisation 
legislation and shall apply as general guidan ce the administrative decisions and documents 
produced as a result of the work of that group. 
Article 25  
Requirements relating to user inspectorates   
1. For the purposes of notification, a user insp ectorate shall meet the requirements laid 
down in paragraphs 2 to 11. 
2. A user inspectorate shall be established under national law and ha ve legal personality. 
3. A user inspectorate shall be organisationa lly 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 assess ment tasks shall not be the de signer, manufacturer, supplier, 
installer, purchaser, owner, us er or maintainer of the pressure equipment which they assess, 
nor the authorised representative of any of those parties. This  shall not preclude the use of 
assessed pressure equipment that is necessary fo r the operations of the user inspectorate or the 
use of such equipment for personal purposes. 
A user inspectorate, its top le vel management and the personne l responsible for carrying out 
the conformity assessment tasks shall not be di rectly involved in the design, manufacture or 
construction, the marketing, installation, use or maintenance of that pressure equipment, or 
represent the parties engaged in those activities.  They shall not engage in any activity that 
may conflict with their independe nce of judgement or integrit y 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 profe ssional integrity and the requisite technical 
competence in the specific field and shall be free from all pre ssures and inducements, EN 58   EN particularly financial, which might influence thei r judgement or the results of their conformity 
assessment activities, esp ecially 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 assessm ent procedure and each  kind or category of 
pressure equipment in relation to which it has be en notified, the user insp ectorate shall have at 
its disposal the necessary: 
(a) personnel with technical knowledge a nd sufficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accord ance with which conformity assessment is 
carried out, ensuring the transparency a nd the ability of reproduction of those 
procedures. It shall have appropriate policies and procedur es in place that 
distinguish between tasks it carries out  as a user inspectorate and other 
activities; 
(c) procedures for the performance of activ ities 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. 
It 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 fo r carrying out conformity asse ssment activities shall have 
the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in rela tion to which the conform ity assessment body has been 
notified; 
(b) satisfactory knowledge of the requireme nts 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 harmoni sation 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 
assessment personnel shall be guaranteed. User  inspectorates must not engage in any 
activities that might conf lict with its independence of judgement and integr ity in relation to its 
inspection activities. EN 59   EN The remuneration of the top level management and assessment personnel 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 obs erve professional secrecy with regard to 
all information obtained in carrying out thei r 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 activ ities are carried out. Proprieta ry rights shall be protected. 
11. User inspectorates sh all participate in, or  ensure that their assessment personnel are 
informed of, the relevant st andardisation activities and th e activities of the notified body 
coordination group established under the relevant  Union harmonisation le gislation and apply 
as general guidance the administrative decisions  and documents produced as a result of the 
work of that group. 
Article 26  [Article R18 of Decision No 768/2008/EC] 
Presumption of conformity 
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 Articles 24 or 25 in  so far as the applicable harmonised standards 
cover those requirements.  
Article 27  [Article R20 of Decision No 768/2008/EC] 
Subsidiaries of and subcontracting by no tified bodies and recognised third-party 
organisations 
1. Where a notified body or a recognised thir d-party organisation subcontracts specific 
tasks connected with conformity assessment or has recourse to a subs idiary, it shall ensure 
that the subcontractor or the subsidiary meets the requirements set out in  Article 24 and shall 
inform the notifying authority accordingly. 
2. Notified bodies and recognised third-party or ganisations shall take  full responsibility 
for the tasks performed by subcontractors or su bsidiaries wherever these are established. 
3. Activities may be subcontracted or carried out by a subsidiary onl y with the agreement 
of the client. 
4. Notified bodies and recognised third-party orga nisations 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 th e work carried out by them under Article 15, 
Annex III or points 3.1.2 and 3.1.3 of Annex I. EN 60   EN Article 28 [Article R22 of Decision No 768/2008/EC] 
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. That application shall be accompanied by a description of the conformity assessment 
activities, the confor mity assessment module or modules and the pressure equipment for 
which that body claims to be competent, as we ll as by an accreditation certificate, where one 
exists, issued by a national accr editation body attesting that the conformity assessment body 
fulfils the requirements laid  down in Article 24 or 25. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and re gular monitoring of its compliance with the 
requirements laid down in Article 24 or 25. 
Article 29 [Article R23 of Decision No 768/2008/EC] 
Notification procedure 
1. Notifying authorities may notify only c onformity assessment bodies which have 
satisfied the requirements laid  down in Article 24 or 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 not ifying authority shall provide th e 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 re quirements laid down in Article 24 or 25. 
5. The body concerned may perform the activit ies 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 with in two weeks of a notification where an 
accreditation certificate is used or  within two months of a notification wh ere 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 Commission and the other Member Stat es shall be notified of any subsequent 
relevant changes to the notification.  EN 61   EN Article 30 [Article R24 of Decision No 768/2008/EC] 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single such number even wh ere the body is notified under several Union acts. 
2. The Commission shall make publicly available the list of the notif ied bodies under this 
Directive, including the identification numbers that have been allocated to them and the 
activities for which they have been notified. 
The Commission shall ensure that that list is kept up to date. 
Article 31  
Lists of recognised third-party or ganisations and user inspectorates 
The Commission shall make publicly availabl e the list of the re cognised third-party 
organisations and of the user inspectorates unde r this Directive and the tasks for which they 
have been recognised.  
The Commission shall ensure that that list is kept up to date. 
Article 32 [Article R25 of Decision No 768/2008/EC] 
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed  that a notified body 
or a recognised third-party or ganisation no longer meets the requi rements 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 seriousn ess of the failure to 
meet those requirements or fulfil those oblig ations. It shall immediately inform the 
Commission and the other Me mber States accordingly. 
Where a notifying authority has ascertained or ha s been informed that a user inspectorate no 
longer meets the requirements laid down in Artic le 25, or that it is  failing to fulfil its 
obligations, the notifying authority  shall as appropriate, restri ct, 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 organisa tion 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 th e responsible notifying a nd market surveillance 
authorities at their request. EN 62   EN Article 33 [Article R26 of Decision No 768/2008/EC] 
Challenge of the competence of notified bodi es, 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 notif ied body, a recognised thir d-party organisation 
or a user inspectorate, or the continued fu lfilment by a notified body, a recognised third-party 
organisation or a user inspectorate of the re quirements and responsibi lities to which it is 
subject. 
2. The notifying Member State shall provi de the Commission, on request, with all 
information relating to the basis for the notific ation or the maintenance of the competence of 
the body concerned. 
3. The Commission shall ensure that all sens itive 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 me et 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 notific ation if necessary. 
The implementing act referred to in the first s ubparagraph shall be adopted in accordance with 
the advisory procedure refe rred to in Article 39(2). 
Article 34 [Article R27 of Decision No 768/2008/EC] 
Operational obligations of notified bodies, user inspectorates and recognised third party 
organisations 
1. Notified bodies, user inspectorates and rec ognised third-party orga nisations shall carry 
out conformity assessments in accordance with the conformity assessment tasks provided for 
in Article 15, Article 16, Annex III 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 acc ount of the size of 
an undertaking, the sector in whic h it operates, its structure, the degree of complexity of the 
pressure equipment or assembly technology in que stion and the mass or serial nature of the 
production process. 
In so doing they shall nevertheless respect th e degree of rigour and the level of protection 
required for the compliance of the pressure equi pment with the provisions of this Directive. 
3. Where a conformity assessment body finds that  essential safety requirements set out in 
Annex I or corresponding harmoni sed standards have not been met by a manufacturer, it shall 
require that manufacturer to take appropriate  corrective measures and shall not issue a 
conformity certificate. EN 63   EN 4. Where, in the course of the monitori ng of conformity following the issue of a 
certificate, a conformity assessment body finds th at pressure equipment no longer complies, it 
shall require the manufacturer to  take appropriate corrective measures and shall suspend or 
withdraw the certific ate if necessary.  
5. Where corrective measures are not taken or do not have the re quired effect, the 
conformity assessment body shall restrict, su spend or withdraw any certificates, as 
appropriate. 
Article 35 
Appeal against decisions of notified bodies , recognised third party organisations and 
user inspectorates 
Member States shall ensure that an appeal procedure against decisi ons of notified bodies, 
recognised third-party orga nisations or user inspec torates is available. 
Article 36 [Article R28 of Decision No 768/2008/EC] 
Information obligation on notified bodies, recognised third party organisations and user 
inspectorates 
1. Notified bodies, recognised third-party or ganisations and user inspectorates shall 
inform the notifying authority of the following: 
(a) any refusal, restriction, suspensi on or withdrawal of a certificate; 
(b) any circumstances affecting the scop e of and conditions for notification; 
(c) any request for information which they have received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activ ities performed within the scope of 
their notification and a ny other activity performe d, including cross-border 
activities and subcontracting. 
2. Notified bodies, recognised third-party or ganisations and user inspectorates shall 
provide the other bodies notified under this Directive carrying out similar conformity 
assessment activities covering the same pressu re equipment with relevant information on 
issues relating to negative and, on request , positive conformity  assessment results. 
Article 37 [Article R29 of Decision No 768/2008/EC] 
Exchange of experience 
The Commission shall provide for the organisati on of exchange of experience between the 
Member States' national authorities responsible for notification policy. EN 64   EN Article 38 [Article R30 of Decision No 768/2008/EC] 
Coordination of notified bodies, recogn ized third-party organisations and user 
inspectorates  
The Commission shall ensure that appropria te 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 conf ormity assessment bodies notified by them 
participate in the work of that or those gr oup or groups, directly or by means of designated 
representatives. 
 
Ð 97/23/EC 
Article 8  
Safeguard clause  
1. Where a Member State ascertains that pressure equipment or assemblies referred to in 
Article 1, bearing the CE marking and us ed in accordance with their intended u se are liable to 
endanger the safety of persons and, where approp riate, domestic animals or property, it shall 
take all appropriate measures to withdraw su ch equipment or assemblies from the market, 
prohibit the placing on the market, putting into service or use thereof, or restrict free 
movement thereof.  
The Member State shall immediately inform th e Commission of any such measure, indicating 
the reasons for its decision and, in particular, whether non -conformity is due to:  
(a) failure to satisfy the essent ial requirements referred to in Article 3;  
(b) incorrect application of the standa rds referred to in Article 5 (2);  
(c) shortcomings in the standards referred to in Article 5 (2);  
(d) shortcomings in the European approval  of pressure equipment materials as  referred to 
in Article 11.  
2. The Commission shall enter into consultatio n with the parties concerned without delay. 
Where the Commission considers, after this cons ultation, that the measur e is justified, it shall 
immediately so inform the Member State wh ich took the initiative and the other Member 
States.  
Where the Commission considers, after this consulta tion, that the measur e is unjustified, it 
shall immediately so inform the Member Stat e which took the initiativ e and the manufacturer, 
or his authorized  representative established within the Community. Where the decision 
referred to in paragraph 1 is based on a shortcom ing in the standards or in European approvals 
for materials and where the Member State at th e origin of the decision maintains its positio n 
the Commission shall immediately inform the Comm ittee referred to in Article 6 in order to 
initiate the procedure referred to in  the first paragraph of Article 6.  EN 65   EN 3. Where pressure equipment or an assembly which does not comply bears the CE marking, 
the competent Member State shall take appropriate  action against the person(s) having affixed 
the CE marking and shall so inform the Co mmission and the other Member S ates. 
4. The Commission shall ensure that the Member Sates  are kept informed of the progress a nd 
outcome of this procedure . 
Article 16  
Unduly affixed CE marking  
Without prejudice to Article 8:  
(a) where a Member State establishes that th e CE marking has been affixed unduly, the 
manufacturer, or his authorized repr esentative established within the C ommunity, shall be 
obliged to make the product conform as regard s the provisions concerning the CE marking 
and to end the infringement under the conditions imposed by the Member State;  
(b) should non -conformity persist, the Member State must take all appro priate measures 
to restrict or prohibit the placing on the market of the product in question or to ensure that it is 
withdrawn from the market in accordance w ith the procedures laid down in Article 8.  
Article 17 
Member States shall take appropriate measure s in order to encourage the authorities 
responsible for implementing this Directive to  cooperate with each other and provide each 
other and the Commission with information in orde r to assist the functioning of this Directive.  
Article 18  
Decisions entailing  refusal or restriction  
Any decision taken pursuant to this Directive which restricts the placing on the market and 
the putting into service or require s the withdrawal from the market of pressure equipment or 
assemblies shall state the exact grounds on whi ch it is based. Such decision shall be notified 
forthwith to the party co ncerned, who shall at the same time be informed of the legal remedies 
available to him under the laws in  force in the Member State co ncerned and of the time limits 
to which such remed ies are subject.  EN 66   EN  
Ð 97/23/EC (adapted) 
CHAPTER 5  
⌦ COMMITTEE PROCEDURE AND DELEGATED ACTS ⌫ 
Article 7  39 
Committee on Pressure Equipment  ⌦ procedure ⌫ 
 
Ð 1882/2003 Art. 1 and Annex 
I.13 (adapted) 
Ö new 
21. The Commission shall be assisted by a standing  committee (hereinafter referred to as «the 
Committee»)  ⌦ the Committee on Pressure Equipm ent established by Directive 
97/23/EC ⌫. Ö That committee shall be a committee wi thin the meaning of Regulation (EU) 
No 182/2011.  
The Committee shall draw up its rules of procedure.  
3 2. Where reference is made to this paragraph,  Article 4 , Articles 3 and 7 of Decision 
1999/468/EC44 Ö of Regulation (EU) No 182/2011  shall apply, having regard to the 
provisions of Article 8 thereof . 
 
Ø new 
3. Where reference is made to this paragra ph, Article 5 of Regulation (EU) No 182/2011 shall 
apply. 
Where the opinion of the committee is to be ob tained by written procedure, that procedure 
shall be terminated without result when, within  the time-limit for delivery of the opinion, the 
chair of the committee so decides or a simple  majority of committee members so request. 
 
Ð 97/23/EC 
4. The Committee may furthermore examin e any other matter relating to the  implementation 
and practical application of this Directive and raised by its chairman  either on his own 
initiative or at the reque st of a Member State.  
                                                 
44 Council Decision 1999/468/EC of 28  June 1999 laying down the procedures for the exercise of 
implementing powers conferred on the Commission  (OJ L 184, 17.7.1999, p.  23). EN 67   EN  
Ø new 
Article 40 
Amendments of Annexes  
The Commission shall be empowered to adopt delegated acts in accordance with Article 41 
concerning the reclassification of pressure equipment when it has any of the following 
considerations: 
 
Ð 97/23/EC  
1. The Commission may take any appropriate m easure to implement the following provisions:  
Where a Member State considers that , for very serious safety reasons,  
 
Ð 97/23/EC (adapted) 
(a) an item or family of pressure equipment referred to in Article 3 4(3) should be 
subject to the require ments of Article 3 4(1),; or 
(b) an assembly or family of assemblies referred to in Article 3 4(3) should be 
subject to the require ments of Article 3 4(2),; or 
 
Ð 97/23/EC  
(c) an item or family of pressure equi pment should be classified, by way of 
derogation from the requirements of  Annex II, in another category, . 
it shall submit a duly substantiated request to th e Commission and ask it to take the necessary 
meas ures. Those measures shall be adopted in accordance with the procedure laid down in 
paragraph 3 .  
 
Ø new 
Article 41 
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 delegation of power referred to in Article 40 shall be conferred  for an 
indeterminate period of time from 1 June 2015. 
3. The delegation of powers refe rred to in Article 40 may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the EN 68   EN 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 valid ity of any delegated act s 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  40 shall enter into force only if no 
objection has been expressed either by the Eur opean Parliament or the Council within a 
period of two months of notifica tion of that act to the European  Parliament and the Council or 
if, before the expiry of that period, the European Parliament a nd 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 Eur opean Parliament or of the Council. 
CHAPTER 6 
TRANSITIONAL AND FINAL PROVISIONS 
Article 42 
Penalties 
Member States shall lay down rules on penalt ies applicable to infringements by economic 
operators of the national provis ions 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 subpa ragraph must be effec tive, proportionate and 
dissuasive. 
 
Ð 97/23/EC (adapted) 
Ö new 
Article 43  
⌦ Transitional provisions  ⌫ 
31. Member States must  permit  ⌦ shall not impede ⌫ the placing on the market  Ö putting 
into service  of pressure equipment and assemblies which comply with the regulations in 
force in their territory at the date of application of this  Directive 97/23/EC  Ö and were placed 
on the market  until 29 May 2002, and permit such equi pment and assemblies to be put into 
service beyond  that date . EN 69   EN  
Ø new 
2. Member States shall not impede the making available on the market and/or the putting 
into service of pressure equi pment 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 issued under Di rective 97/23/EC shall be va lid under this Directive.  
 
Ð 97/23/EC (adapted) 
Article 20 44 
Transposition and transition al provisions  
1. Before 29 May 1999  Member States shall adopt and publish ⌦ by 1 March 2015 at the 
latest, ⌫ the laws, regulations and administrative pr ovisions necessary to comply with this 
Directive  ⌦ Articles 2(15) to (31), 6, 7, 8, 9, 10, 11, 12, 17, 18, 19(3) to (5), 20, 21, 22, 23, 
24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 42, 43 and Annexes III and IV  ⌫. 
They shall forthwith inform  ⌦ communicate to ⌫ the Commission thereof  ⌦ the text of 
those measures ⌫ . 
Member States  ⌦ They ⌫ shall apply such  ⌦ those measures ⌫ provisions as  from 29 
November 1999  ⌦ 1 June 2015 ⌫ . 
When Member States adopt these  ⌦ those ⌫ measures referred  to in the first subparagraph , 
they shall contain a reference to this Directive or shall  be accompanied by such reference on 
the occasion of their official publicati on. The methods of making such reference s hall be laid 
down by Member States.  ⌦ They shall also include a statem ent that references in existing 
laws, regulations and administra tive provisions to Directive 97/ 23/EC shall be construed as 
references to this Directive. Member States sh all determine how such re ference is to be made 
and how that statement is to be formulated. ⌫ 
2. Member States shall communicat e to the Commission the texts  of the ⌦ main ⌫ 
provisions of national law which they adopt in the field governed by this Directive. 
Article 19  45 
Repeal 
Article 22 of Directive 76/767/EEC shall cease to apply as from 29 November 1999 in respect 
of pressure equipment and assemb lies covered by this Directive.  
 
Ð  
Directive 97/23/EC, as amended by th e acts listed in Annex V, Part  A, is repealed with effect 
from 1 June 2015, without prejudice to the obliga tions of the Member St ates relating to the EN 70   EN time-limits for transposition into national law and application of that Directive, set out in Part 
B of Annex V.  
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 46 
Entry into force 
This Directive shall enter into force on the tw entieth day following that  of its publication in 
the Official Journal of  the European Union . 
Articles 1, 2(1) to (14), 3, 4, 5, 13, 14, 15, 16, 19( 1) and (2), 39, 40 and 41 and Annexes I and 
II shall apply from 1 June 2015.  
 
Ð 97/23/EC 
Article 47  
Addressees of the Directive 
This Directive is addressed to the Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President EN 71   EN  
 
Ð 97/23/EC 
ANNEX I  
ESSENTIAL SAFETY REQUIREMENTS 
PRELIMINARY  OBSERVATIONS 
 
Ð 97/23/EC (adapted) 
1. The obligations arising from the essential ⌦ safety ⌫ requirements listed in this Annex 
for pressure equipment also apply to assemblies where the corresponding hazard  ⌦ risk ⌫ 
exists. 
2. The essential ⌦ safety ⌫ requirements laid down in the  ⌦ this ⌫ Directive are 
compulsory. The obligations laid down  ⌦ following from ⌫ in these  ⌦ those ⌫ essential 
⌦ safety ⌫ requirements apply only if the corresponding hazard  ⌦ risk ⌫ exists for the 
pressure equipment in question when it is  used under conditions which are reasonably 
foreseeable by the manufacturer. 
3. The manufacturer is under an ob ligation to analyse the hazards  ⌦ risks ⌫ in order to 
identify those which apply to his equi pment on account of pressure; he must  ⌦ shall ⌫ then 
design and construct it taki ng account of his analysis. 
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 a nd 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. 
1. GENERAL 
1.1. Pressure equipment must  ⌦ 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 instructio ns, or in reasonably foreseeable conditions. 
1.2. In choosing the most appropriate solutions, the manufacturer must  ⌦ shall ⌫ apply the 
principles set out below in the following order: 
– eliminate or reduce hazards  ⌦ risks ⌫ as far as is reasonably practicable, ; 
– apply appropriate protection measures against hazards  ⌦ risks ⌫ which cannot be 
eliminated, ; 
– where appropriate, inform users of residual hazards  ⌦ risks ⌫ 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 must  ⌦ shall ⌫ be designed to prevent danger from such misuse or, if that is not EN 72   EN possible, adequate warning given that the pressure equipment must  ⌦ shall ⌫ not be used in 
that way. 
2. DESIGN 
2.1. General The pressure equipment must
 ⌦ shall ⌫ be properly designed taki ng all relevant factors 
into account in order to ensure that the e quipment will be safe throughout its intended life. 
The design must  ⌦ 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 
2.2.1. The pressure equipment must  ⌦ shall ⌫ be designed for loadings appropriate to its 
intended use and other reasonably foreseeable operating conditions. In particular, the following factors must
 ⌦ shall ⌫ be taken into account: 
 
Ð 97/23/EC 
– internal/external pressure, ; 
– ambient and operational temperatures, ; 
– static pressure and mass of conten ts 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. 
 
Ð 97/23/EC (adapted) 
Various loadings which can occur at the same time must  ⌦ shall ⌫ be considered, taking 
into account the probability of  their simultaneous occurrence. 
2.2.2. Design for adequate strength must  ⌦ shall ⌫ be based on ⌦ either of the 
following ⌫: 
– as a general rule, a calculation method, as  described in 2.2.3, and supplemented if 
necessary by an experimental de sign method as described in 2.2.4, ; or EN 73   EN  
Ð 97/23/EC 
– an experimental design method without cal culation, as described in 2.2.4, when the 
product of the maximum allowable pressure PS and the volume V is less than 6000 bar·L or the product PS·DN less than 3000 bar. 
2.2.3. Calculation method (a) Pressure containment and other loading aspects 
 
Ð 97/23/EC (adapted) 
The allowable stresses for pressure equipment must  ⌦ shall ⌫ be limited having regard to 
reasonably foreseeable failure modes under opera ting conditions. To this end, safety factors 
must  ⌦ shall ⌫ be applied to eliminate fully any unc ertainty arising out of manufacture, 
actual operational conditions, stresse s, calculation models and th e properties and behaviour of 
the material. 
These calculation methods must  ⌦ shall ⌫ provide sufficient safety margins consistent, 
where applicable, with the requirements of section  point  7. 
 
Ð 97/23/EC 
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 
 
Ð 97/23/EC (adapted) 
Appropriate design calculations must  ⌦ shall ⌫ be used to establish the resistance of the 
pressure equipment concerned. 
In particular: 
– the calculation pressures must  ⌦ 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 chambe rs, the partition wall must  ⌦ shall ⌫ be designed on 
the basis of the highest possible chamber pr essure relative to the lowest pressure 
possible in the adjoining chamber, 
– the calculation temperatures must  ⌦ shall ⌫ allow for appropriate safety margins, EN 74   EN – the design must  ⌦ shall ⌫ take appropriate account of all possible combinations of 
temperature and pressure which might aris e under reasonably foreseeable operating 
conditions for the equipment, 
– the maximum stresses and peak  stress concentrations must  ⌦ shall ⌫ be kept 
within safe limits, 
– the calculation for pressure containment must  ⌦ shall ⌫ utiliz se the values 
appropriate to the properti es of the material, based on documented data, having 
regard to the provisions  set out in section  point  4 together with appropriate safety 
factors. Material characteristics to be  considered, where applicable, include: 
 
Ð 97/23/EC 
– yield strength, 0,2 % or 1,0 % proof stre ngth as appropriat e at calculation 
temperature, ; 
– tensile strength, ; 
– time-dependent strength, i.e. creep strength, ; 
– fatigue data, ; 
– Young's modulus (modu lus of elasticity), ; 
– appropriate amount of plastic strain, ; 
 
Ð 97/23/EC (adapted) 
– impact strength  ⌦ bending rupture energy ⌫ ,; 
 
Ð 97/23/EC 
– fracture toughness, . 
 
Ð 97/23/EC  (adapted) 
– appropriate joint factors must  ⌦ shall ⌫ be applied to the material properties 
depending, for example, on the type of non-de structive testing, the materials joined 
and the operating conditions envisaged, ; 
– the design must  ⌦ shall ⌫ take appropriate account of  all reasonably foreseeable 
degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the 
intended use of the equi pment. Attention must  ⌦ shall ⌫ be drawn, in the 
instructions referred to in section  point  3.4, to particular features of the design which 
are relevant to the life of the equipment, for example: 
 
Ð 97/23/EC 
– for creep: design hours of operation at specified temperatures, ; EN 75   EN – for fatigue: design number of cycles  at specified stress levels, ; 
– for corrosion: design corrosion allowance; . 
(c) Stability aspects 
 
Ð 97/23/EC  (adapted) 
Where the calculated thickness does not allow for adequate structural st ability, the necessary 
measures must  ⌦ shall ⌫ be taken to remedy the situat ion taking into account the risks 
from transport and handling. 
 
Ð 97/23/EC 
2.2.4. Experimental design method 
The design of the equipment ma y be validated, in all or in part, by an appropriate test 
programme carried out on a sample representa tive of the equipment or the category of 
equipment. 
 
Ð 97/23/EC  (adapted) 
The test programme must  ⌦ shall ⌫ be clearly defined prior to  testing and accepted by the 
notified body responsible for the design conf ormity assessment module, where it exists. 
This programme must  ⌦ shall ⌫ define test conditions and criteria for acceptance or 
refusal. The actual values of the essential di mensions and characteristics of the materials 
which constitute the equipment tested shall be measured before the test. 
Where appropriate, during tests, it must  ⌦ shall ⌫ be possible to obser ve the critical zones 
of the pressure equipment with adequate inst rumentation capable of registering strains and 
stresses with sufficient precision. 
The test programme must  ⌦ shall ⌫ include: 
 
Ð 97/23/EC 
(a) A pressure strength test, th e purpose of which is to check  that, at a pressure with a 
defined safety margin in relation to the maxi mum allowable pressure, the equipment does not 
exhibit significant leaks or deforma tion exceeding a determined threshold. 
 
Ð 97/23/EC  (adapted) 
The test pressure must  ⌦ shall ⌫ be determined on the basis of the differences between the 
values of the geometrical and material charact eristics measures under test conditions and the 
values used for design purposes; it must  ⌦ shall ⌫ take into account the differences 
between the test and design temperatures; EN 76   EN (b) where the risk of creep or fatigue exists , appropriate tests dete rmined on the basis of 
the service conditions laid down for the equi pment, for instance hold time at specified 
temperatures, number of cycles at specified stress-levels,  etc.; 
(c) where necessary, additional tests concerning other factors referred to in 2.2.1 such as 
corrosion, external damage,  etc. 
2.3. Provisions to ensure safe handling and operation 
The method of operation specified  for pressure equipment must  ⌦ shall ⌫ b e  s u c h  a s  t o  
preclude any reasonably foreseeable risk in oper ation of the equipment. Particular attention 
must  ⌦ shall ⌫ be paid, where appropriate, to: 
 
Ð 97/23/EC 
– closures and openings, ; 
– dangerous discharge of pressure relief blow-off, ; 
– devices to prevent physical access wh ilst pressure or a vacuum exists, ; 
– surface temperature taking into consideration the intended use, ; 
– decomposition of unstable fluids. 
 
Ð 97/23/EC (adapted) 
In particular, pressure equipm ent fitted with an access door must  ⌦ shall ⌫ be equipped 
with an automatic or manual device enabling the user easily to ascertai n that the opening will 
not present any hazard  ⌦ risk ⌫ . Furthermore, where the opening can be operated quickly, 
the pressure equipment must  ⌦ shall ⌫ be fitted with a device to prevent it being opened 
whenever the pressure or temperature of the fluid presents a hazard  ⌦ risk ⌫ . 
2.4. Means of examination 
(a) Pressure equipment must  ⌦ shall ⌫ be designed and constructed so that all 
necessary examinations to ensu re safety can be carried out; 
(b) Means of determining the internal condition of the equipment must  ⌦ shall ⌫ be 
available, where it is necessary to ensure the continued safety of the equipment, such as 
access openings allowing physical access to the in side of the pressure  equipment so that 
appropriate examinations can be ca rried out safely and ergonomically; 
(c) Other means of ensuring the safe condition of the pressure equipment may be applied 
⌦ in any of the following situations ⌫ : 
– where it is too small for physical internal access,  or; 
– where opening the pressure equipment would adversely affect the inside,  or; EN 77   EN  
Ð 97/23/EC 
– where the substance contained has been s hown 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 
 
Ð 97/23/EC (adapted) 
Adequate means must  ⌦ shall ⌫ be provided for the draini ng and venting of pressure 
equipment where necessary: 
– to avoid harmful effects such as wate r hammer, vacuum collapse, corrosion and 
uncontrolled chemical reactions. All stages  of operation and testing, particularly 
pressure testing, must  ⌦ shall ⌫ be considered, ; 
 
Ð 97/23/EC 
– to permit cleaning, inspection and maintenance in a safe manner. 
2.6. Corrosion or other chemical attack 
 
Ð 97/23/EC (adapted) 
Where necessary, adequate allowance or protecti on against corrosion or other chemical attack 
must  ⌦ shall ⌫ be provided, taking due account of the intended and reasonably foreseeable 
use. 
2.7. Wear 
Where severe conditions of erosion or ab rasion may arise, adequate measures must  
⌦ shall ⌫ be taken to: 
 
Ð 97/23/EC 
– minimize 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 instru ctions referre d to in point  3.4, to measures necessary for 
continued safe use. 
2.8. Assemblies 
 
Ð 97/23/EC (adapted) 
Assemblies must  ⌦ shall ⌫ be so designed that: EN 78   EN  
Ð 97/23/EC 
– 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 
 
Ð 97/23/EC (adapted) 
Where appropriate, the pressure equipment must  ⌦ shall ⌫ be so designe d and provided 
with accessories, or provision made for their fitt ing, as to ensure safe filling and discharge in 
particular with respect to hazard s ⌦ risks ⌫ such as: 
 
Ð 97/23/EC 
(a) on filling: 
– overfilling or overpressu rization having regard in partic ular to the filling ratio and 
to vapour pressure at the reference temperature, ; 
– instability of the pressure equipment; 
(b) on discharge: the uncontrolled re lease of the pressurized fluid; 
(c) on filling or discharge: unsafe connection and disconnection. 
2.10. Protection against exceeding the allow able limits of pressure equipment 
 
Ð 97/23/EC (adapted) 
Where, under reasonably foreseeable conditions, th e allowable limits could be exceeded, the 
pressure equipment must  ⌦ 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 comb ination of such devices must
 ⌦ shall ⌫ be determined on the 
basis of the particular characteristics of the equipment or assembly. 
 
Ð 97/23/EC 
Suitable protective devices and combinations thereof comprise: 
(a) safety accessories as defined in Article 1 2(4), section 2.1.3,  
(b) where appropriate, adequate monitoring de vices such as indica tors and/or alarms 
which enable adequate action to  be taken either automatically or manually to keep the 
pressure equipment within the allowable limits. EN 79   EN 2.11. Safety accessories 
 
Ð 97/23/EC (adapted) 
2.11.1. Safety accessories must  ⌦ shall ⌫: 
 
Ð 97/23/EC 
– be so designed and construc ted 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 th eir 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 
 
Ð 97/23/EC (adapted) 
These devices must  ⌦ shall ⌫ be so designed that the pressure will not permanently exceed 
the maximum allowable pressure PS; however a s hort duration pressure su rge in keeping with 
the specifications laid down in 7.3 is allowable, where appropriate. 
2.11.3. Temperature monitoring devices These devices must
 ⌦ shall ⌫ have an adequate response time on safety grounds, consistent 
with the measurement function. 
2.12. External fire 
Where necessary, pressure equipment must  ⌦ 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 par ticular regard to its 
intended use. 
3. MANUFACTURING 
3.1. Manufacturing procedures The manufacturer must
 ⌦ shall ⌫ ensure the competent executio n 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 Preparation of the component part s (e.g. forming and chamfering) must
 ⌦ shall ⌫ not give 
rise to defects or cracks or cha nges in the mechanical characteristics likely to be detrimental 
to the safety of the pressure equipment. EN 80   EN 3.1.2. Permanent joining 
Permanent joints and adjacent zones must  ⌦ shall ⌫ be free of any surface or internal 
defects detrimental to the safety of the equipment. 
The properties of permanent joints must  ⌦ shall ⌫ meet the minimum properties specified 
for the materials to be joined unless other rele vant property values are specifically taken into 
account in the design calculations. 
For pressure equipment, permanent joining of  components which contri bute to the pressure 
resistance of equipment and components wh ich are directly attached to them must  
⌦ shall ⌫ be carried out by suitably qualified pe rsonnel according to suitable operating 
procedures. 
For pressure equipment in categories II, III and IV, operating procedures and personnel must  
⌦ shall ⌫ be approved by a competent third party which, at the manufacturer's discretion, 
may be: 
 
Ð 97/23/EC 
– a notified body, ; 
– a third-party organization recognized by a Me mber State as provided for in Article 
1320. 
 
Ð 97/23/EC (adapted) 
Ö new 
To carry out these approvals the third party must  perform examinations a nd tests as set out in 
the appropriate harmonised standards or eq uivalent examinations and tests or must  
⌦ shall ⌫ have them performed. 
3.1.3. Non-destructive tests For pressure equipment, non-destruct ive tests of permanent joints must
 ⌦ shall ⌫ be carried 
out by suitable qualified personne l. For pressure equipment in  categories III and IV, the 
personnel must  ⌦ shall ⌫ be approved by a third-party organiz sation recognized by a 
Member State pursuant to Article 13 20. 
3.1.4. Heat treatment Where there is a risk that the manufacturing process will change the material properties to an 
extent which would impair the sa fety of the pressure equipmen t, suitable heat treatment must
 
⌦ shall ⌫ be applied at the appropria te stage of manufacture. 
3.1.5. Traceability Suitable procedures must
 ⌦ shall ⌫ be established and maintained for identifying the 
material making up the components of the equipm ent which contribute to pressure resistance 
by suitable means from receipt,  through production, up to the fina l test of the manufactured 
pressure equipment. EN 81   EN 3.2. Final assessment 
Pressure equipment must  ⌦ shall ⌫ be subjected to final assessment as described below. 
3.2.1. Final inspection Pressure equipment must
 ⌦ shall ⌫ undergo a final inspection to assess visually and by 
examination of the accompanying documents compliance with the requirements of the 
Directive. Test carried out dur ing manufacture may be taken into account. As far as is 
necessary on safety grounds, the final inspection must  ⌦ 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 fina l inspection is no longer possible). 
3.2.2. Proof test Final assessment of pressure equipment must
 ⌦ shall ⌫ include a test for the pressure 
containment aspect, which will normally take th e form of a hydrostatic pressure test at a 
pressure at least equal, where appropriate, to the value laid down in 7.4. 
For category I series-produced pressure equipment,  this test may be pe rformed on a statistical 
basis. 
Where the hydrostatic pressure test  is harmful or impractical, ot her tests of a recognized value 
may be carried out. For tests other than the hy drostatic pressure test, additional measures, 
such as non-destructive tests or othe r methods of equivalent validity, must  ⌦ shall ⌫ be 
applied before those tests are carried out. 
3.2.3. Inspection of safety devices For assemblies, the final assessment must
 ⌦ shall ⌫ also include a check of the safety 
devices intended to check full compliance with the requirements referred to in 2.10. 
3.3. Marking and labelling 
In addition to the CE marking referred to in Articles  15 18 and 19 , the following information 
must  ⌦ shall ⌫ be provided: 
(a) for all pressure equipment: 
– the name and address or other means of identification of the manufacturer and, 
where appropriate, of his authorized re presentative established within the 
Community  Ö the importer  ,; 
 
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– 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; . EN 82   EN (b) depending on the type of pressure equipm ent, further information necessary for safe 
installation, operation or  use and, where applicable, mainte nance and periodic inspection such 
as: 
– the volume V of the pressure equipment in L, ; 
– the nominal size for piping DN, ; 
– the test pressure PT a pplied 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, ; 
 
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Ö new 
– the product  Ö fluid  group; . 
 
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(c) where necessary, warnings fixed to the pressure equipment drawing attention to 
misuse which experience has shown might occur. 
 
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The CE marking and the required information must  ⌦ shall ⌫ be given on the pressure 
equipment or on a dataplate firmly attach ed to it, with the following exceptions: 
 
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– where applicable, appropriate documenta tion may be used to avoid repetitive 
marking of individual parts such as pi ping components, intended for the same 
assembly. This applies to CE marking and other marking and labelling referred to in 
this Annex; 
– where the pressure equipment is too small, e.g. accessories, the information referred 
to in point  (b) may be given on a label attached to that pressure equipment; EN 83   EN – 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 le gible for the appropriate 
period of time. 
3.4. Operating instructions 
 
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Ö new 
(a) When pressure equipment is placed  Ö made available  on the market, it must  
⌦ shall ⌫ be accompanied, as far as relevant, with instructions for the user, containing all 
the necessary safety information relating to: 
 
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– mounting including assembling of differe nt pieces of pressure equipment, ; 
– putting into service, ; 
– use,; 
– maintenance including checks by the user; . 
 
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(b) Instructions must  ⌦ shall ⌫ cover information affixed to  the pressure equipment in 
accordance with 3.3, with the exception of serial identification, and must  ⌦ shall ⌫ be 
accompanied, where appropriate, by the tec hnical documents, drawings and diagrams  
⌦ schemes ⌫ necessary for a full understand ing of these instructions; 
(c) If appropriate, th ese instructions must  ⌦ shall ⌫ also refer to hazards  ⌦ risks ⌫ 
arising from misuse in accordance with 1.3 and pa rticular features of the design in accordance 
with 2.2.3. 
4. MATERIALS 
Materials used for the manufact ure of pressure equipment must  ⌦ shall ⌫ be suitable for 
such application during the scheduled lifetime unless replacement is foreseen. 
 
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Welding consumables and other joining materials need fulfil only the rele vant requirements of 
4.1, 4.2 (a) and the first paragraph of 4.3, in an  appropriate way, both individually and in a 
joined structure. 
 
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4.1. Materials for pressuriz sed parts must  ⌦ shall ⌫: 
(a) have appropriate properties for all operating conditions wh ich are reasonably 
foreseeable and for all test conditions, and in pa rticular they should be sufficiently ductile and EN 84   EN tough. Where appropriate, the characteristics of the materials must  ⌦ shall ⌫ comply with 
the requirements of 7.5. Moreover, due care shoul d be exercised in part icular in selecting 
materials in order to prevent brittle-type fract ure where necessary; where for specific reasons 
brittle material has to be us ed appropriate measures must  ⌦ shall ⌫ be taken; 
(b) be sufficiently chemically resistant to th e fluid contained in the pressure equipment; 
the chemical and physical properties necessary for operational safety must  ⌦ shall ⌫ not be 
significantly affected within the sc heduled lifetime of the equipment; 
 
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(c) not be significantly affected by ageing; 
(d) be suitable for the intended processing procedures; (e) be selected in order to avoid significant  undesirable effects when the various materials 
are put together. 
 
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4.2. ⌦ The pressure equipment manufacturer shall ⌫: 
(a) The pressure equipment manufacturer must  define in an appropriate manner the values 
necessary for the design calculations referred to in 2.2.3 and the essential characteristics of the 
materials and their treatment referred to in 4.1; 
(b) the  manufacturer must  provide in his technical docum entation elements relating to 
compliance with the materials specifications of  the Directive in one of the following forms: 
 
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– by using materials which comply with harmonised standards, ; 
– by using materials covered by a Europ ean approval of pressure equipment 
materials in accordance with Article 11 15,; 
– by a particular material appraisal; . 
 
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(c) for pressure equipment in categories III and IV, ⌦ a specific assessment of the ⌫ 
particular ⌦ material ⌫ appraisal as referred to in the third indent of (b ) must  ⌦ shall ⌫ 
be performed by the notified body in charge of  conformity assessment procedures for the 
pressure equipment. 
4.3. The equipment manufacturer must  ⌦ shall ⌫ take appropriate meas ures to ensure that 
the material used conforms with the requir ed specification. In pa rticular, documentation 
prepared by the material manufacturer affi rming compliance with a specification must  
⌦ shall ⌫ be obtained for all materials. EN 85   EN For the main pressure-bearing parts of equipm ent in categories II, III and IV, this must  
⌦ shall ⌫ take the form of a certificat e of specific product control. 
Where a material manufacturer has an appropriate quality-assurance system, certified by a 
competent body establishe d within the Community  ⌦ Union ⌫ and having undergone a 
specific assessment for materials, certificates issued by the manufacturer are presumed to 
certify conformity with the releva nt requirements of this section  point . 
 
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SPECIFIC  PRESSURE  EQUIPMENT  REQUIREMENTS 
In addition to the applicable requirements of sections  points  1 to 4, the following 
requirements apply to the pressu re equipment covered by sections  points  5 and 6. 
5. FIRED OR OTHERWISE HEATED PRE SSURE EQUIPMENT WITH A RISK OF 
OVERHEATING AS REFERR ED TO IN ARTICLE 3 4 (1) 
This pressure equipment includes: 
 
Ð 97/23/EC (adapted) 
– steam and hot-water generators as referred to in Article 3 4(b), section 1.2,  such as 
fired steam and hot-water boilers, superhea ters and reheaters, waste-heat boilers, 
waste incineration boilers, electrode or im mersion-type electrically heated boilers, 
pressure cookers, together with their accesso ries and where applicable their systems 
for treatment of feedwater and for fuel supply, ; and 
– process-heating equipment for other than  steam and hot water generation falling 
under Article 3 4(a), section 1.1,  such as heaters for chemical and other similar 
processes and pressuriz sed food-processing equipment. 
This pressure equipment must  ⌦ shall ⌫ be calculated, designed and constructed so as to 
avoid to  ⌦ or ⌫ minimize risks of a significant loss of containment from overheating. In 
particular it must  ⌦ shall ⌫ be ensured, where applicable, that: 
 
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(a) appropriate means of protection are provide d to restrict operating parameters such as 
heat input, heat take-off and, where applicable, fl uid level so as to avoid any risk of local and 
general overheating, ; 
(b) sampling points are provided where require d to allow evaluation of the properties of 
the fluid so as to avoid risks re lated to deposits and/or corrosion, ; 
(c) adequate provisions are made to e liminate risks of damage from deposits, ; 
(d) means of safe removal of residual heat after shutdown are provided, ; EN 86   EN (e) steps are taken to avoid a dangerous accumulation of igni table mixtures of 
combustible substances and air, or flame blowback. 
 
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6. PIPING AS REFERRED TO IN ARTICLE 3 4 (c), SECTION 1.3  
Design and construction must  ⌦ shall ⌫ ensure: 
 
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(a) that the risk of overstressing from inad missible free movement or excessive forces 
being produced, e.g. on flanges, connections, bellows or hoses, is adequately controlled by means such as support, constraint, an choring, alignment and pre-tension; 
(b) that where there is a possi bility of condensation occurr ing 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; 
(c) that due consideration is given to the pot ential damage from turbulence and formation 
of vortices; the relevant pa rts of 2.7 are applicable; 
(d) that due consideration is given to the ri sk of fatigue due to vibrations in pipes; 
(e) that, where fluids of Group 1 are cont ained in the piping, appropriate means are 
provided to isolate «take-off» pipes the si ze of which represents a significant risk; 
 
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(f) that the risk of inad vertent discharge is minimi zed; the take-off points must  
⌦ shall ⌫ be clearly marked on the permanent side, indicating the fluid contained; 
 
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(g) that the position and route of underground piping is at leas t recorded in the technical 
documentation to facilitate safe maintenance, inspection or repair. 
7. SPECIFIC QUANTITATIVE REQUIR EMENTS FOR CERTAIN PRESSURE 
EQUIPMENT 
 
Ð 97/23/EC (adapted) 
The following provisions apply as a general ru le. However, where th ey are not applied, 
including in cases where materials are not  specifically referred to and no harmonised 
standards are applied, the manufacturer must  ⌦ shall ⌫ demonstrate that appropriate 
measures have been taken to achieve an equivalent overall level of safety. 
This section is an inte gral part of Annex I.  The provisions laid down in this section 
supplement the essential ⌦ safety ⌫ requirements of sections  points  1 to 6 for the pressure 
equipment to which they apply. EN 87   EN  
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7.1. Allowable stresses 
7.1.1. Symbols 
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. 
 
Ð 97/23/EC (adapted) 
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 must  ⌦ shall ⌫ not exceed the 
smaller of the following values, according to the material used: 
 
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– in the case of ferritic steel including normalized (normalized 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 elonga tion 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 
 
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For welded joints, the joint coefficient must  ⌦ shall ⌫ not exceed the following values: EN 88   EN  
Ð 97/23/EC 
– for equipment subject to destructive and non- destructive tests which confirm that the 
whole series of joints sh ow 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. 
 
Ð 97/23/EC (adapted) 
If necessary, the type of stress and the mechan ical and technological pr operties of the joint 
must  ⌦ shall ⌫ also be taken into account. 
7.3. Pressure limiting devices, parti cularly for pressure vessels 
The momentary pressure surg e referred to in 2.11.2 must  ⌦ shall ⌫ be kept to 10 % of the 
maximum allowable pressure. 
7.4. Hydrostatic test pressure 
For pressure vessels, the hydrostatic te st pressure referred to in 3.2.2 must  ⌦ shall ⌫ be no 
less than ⌦ either of the following ⌫: 
– that corresponding to th e maximum loading to which th e 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,
; or 
– the maximum allowable pressure multiplied by the coefficient 1,43, whichever is the 
greater. 
7.5. Material characteristics 
Unless other values are required in acco rdance with other criteria that must  ⌦ shall ⌫ be 
taken into account, a steel is considered as suffi ciently ductile to satisfy 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.EN 89   EN  
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ANNEX II  
CONFORMITY ASSESSMENT TABLES 
1. The references in the tables to ca tegories of modules are the following: 
 
Ð 97/23/EC (adapted) 
I = Module A 
II = Module A1 2, D1, E1 
III = Modules B1  ⌦ (design type) ⌫ + D, 
B1 ⌦ (design type) ⌫ + F, B 
⌦ (combination of production type and 
design type) ⌫ + E, B ⌦ (combination 
of production type and design type) ⌫ 
+ C1 2, H 
IV = Modules B ⌦ (combination of 
production type and design type) ⌫ + 
D, B ⌦ (combination of production 
type and design type) ⌫ + F, G, H1 
 
2. The safety accessories defined in Article 1 2(4), Section 2.1.3,  and referred to in Article 
34(1)(d) , Section 1.4,  are classified in ca tegory IV. However, by way of exception, safety 
accessories manufactured for specific equipment ma y be classified in the same category as the 
equipment they protect. 
3. The pressure accessories defined in Article 1 2(5), Section 2.1.4,  and referred to in Article 
34(1)(d) , Section 1.4,  are classified on the basis of: 
– their maximum allowable pressure PS, ; and 
– their volume V or their nomina l size DN, as appropriate, ; and 
– the group of fluids for which they are intended, . 
and tThe 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 c onsidered appropriate in  the second indent 
⌦ of the first subparagraph ⌫, the pressure accessory must  ⌦ shall ⌫ be classified in the 
highest category. EN 90   EN  
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4. The demarcation lines in the following conf ormity assessment tables indicate the upper 
limit for each category. 
 
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⌦ 
  ⌫ 
Table 1 
Vessels referred to in Article 3 4, Section 1.1  (1)(a)(i) , first indent 
Exceptionally, vessels intended to contain an unst able gas and falling within categories I or II 
on the basis of table 1 must  ⌦ shall ⌫ be classified in category III. EN 91   EN ⌦ 
  ⌫ 
Table 2 
Vessels referred to in Article 3 4, Section 1 .1 (1)(a)(i) , second indent 
Exceptionally, portable extinguishers and bottles for breathing equipment must  ⌦ shall ⌫ 
be classified at le ast in category III. EN 92   EN ⌦ 
  ⌫ 
Table 3 
Vessels referred to in Article 3 4, Section 1.1  (1)(ba)(ii), first indentEN 93   EN ⌦ 
  ⌫ 
Table 4 
Vessels referred to in Article 3 4(1)(a)(ii) , Section 1.1 (b) , second indent 
Exceptionally, assemblies intended for generating warm water as referred to in Article 3 4 
(2)(c) , Section 2.3,  must  ⌦ shall ⌫ b e  s u b j e c t  e i t h e r  t o  a n  E C  design  ⌦ EU-type ⌫ 
examination (Module B1  ⌦ - design type ⌫ ) with respect to their conformity with the 
essential requirements referred to in Sections  points  2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I, 
or to full quality assurance (Module H). EN 94   EN ⌦ 
  ⌫ 
Table 5 
Pressure equipment ref erred to in Article 3 4(1)(b), Section 1.2  
Exceptionally, the design of pressure-cookers must  ⌦ shall ⌫ be subject to a conformity 
assessment procedure equivalent to at least one of the cat egory III modules. EN 95   EN ⌦ 
  ⌫  
 
Table 6 
Piping referred to in Article 3 4(1)(c)(i) , Section 1.3 (a),  first indent 
Exceptionally, piping intended for unstable gases and falling within categories I or II on the 
basis of Table 6 must  ⌦ shall ⌫ be classified in category III. EN 96   EN ⌦ 
  ⌫ 
Table 7 
Piping referred to in Article 3 4(1)(c)(i) , Section 1.3 (a),  second indent 
Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling 
within category II on the basis of Table 7 must  ⌦ shall ⌫ be classified in category III. EN 97   EN ⌦ 
  ⌫ 
Table 8 
Piping referred to in Article 3 4(1)(c)(ii) , Section 1.3 (b),  first indentEN 98   EN ⌦ 
  ⌫  
 
Table 9 
Piping referred to in Article 3 4(1)(c)(ii) , Section 1.3 (b),  second indentEN 99   EN  
Ð 97/23/EC 
ANNEX III  
CONFORMITY ASSESSMENT PROCEDURES 
The obligations arising from the provisions on pr essure equipment in this Annex also apply to 
assemblies. 
1. MODULE A: (INTERNAL PRODUCTION CONTROL ) 
1. This module describes  the procedure whereby the manu facturer or his authorized 
representative established within the Community  who carries out the obl igations laid down in 
section 2 ensures and declares that pressure  equipment satisfies the requirements of the 
Directive which apply to it.  
The manufacturer, or his authorized represen tative established within the Community, must 
affix the CE marking to each item of pressure equipment and draw up a written declaration of 
conformity.  
 
Ø new 
1. Internal production control is the conf ormity assessment procedure whereby the 
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares 
on his sole responsibilit y that the pressure equipment conc erned satisfy the requirements of 
this Directive. 
 
Ð 97/23/EC (adapted) 
2. ⌦ Technical documentation ⌫ 
The manufacturer must draw up  ⌦ shall establish ⌫ the technical documentation.  described 
in section 3 and eith er the manufacturer or his authorized representa tive established within the 
Community must keep it at the disposal of the relevant national authorities for inspection 
purposes for a period of ten years after the last of the pressure equipment has been 
manufactured.  
 
Ð 97/23/EC 
Where neither the manufacturer nor his authori zed representative is established within the 
Community, the obligation to keep the technical documentation available is the responsibility 
of the person who places the pressure equipment on the Community market.  
 
Ð 97/23/EC (adapted) 
Ö new 
3. The technical documentation must enable  ⌦ shall make it possible to ⌫ an assessment  to 
be made of  the conformity of the pressure equipment with  ⌦ to ⌫ the ⌦ relevant ⌫ 
requirements Ö, and shall include an adequate anal ysis and assessment of the risk(s).  EN 100   EN ⌦ The technical documentation shall specify the applicable requirements and cover, ⌫ of 
the Directive which apply to it. It must,  as far as is  relevant for such  ⌦ the ⌫ assessment, 
cover  the design, manufacture and operati on of the pressure equipment. ⌦ The technical 
documentation shall, wherever applicable, ⌫ and  contain ⌦ at least the following 
elements ⌫ : 
 
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– a general description of the pressure equipment, ; 
 
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Ö new 
– conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ of 
components, sub-assemblies, circuits, etc., ; 
– descriptions and explanations nece ssary for an understanding of the said 
⌦ those ⌫ drawings and diagrams  ⌦ schemes ⌫ and the operation of the 
pressure equipment, ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5  ⌦ the references of 
which have been published in the Official Journal of the European Union  ⌫, 
applied in full or in part, and a descrip tion of the solutions adopted to meet the 
essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ Directive where the  ⌦ those 
harmonised ⌫ standards referred to in Article 5  have not been applied, . Ö In the 
event of partly applied harmonised standa rds, the technical documentation shall 
specify the parts which have been applied;  
 
Ð 97/23/EC 
– results of design calculations made , examinations carried out, etc., ; 
– test reports. 
4. The manufacturer, or his authorized repr esentative established within the Communi ty, must 
keep a copy of the declaration of conf ormity with the technical documentation.  
 
Ð 97/23/EC (adapted) 
Ö new 
53. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ take all measures necessary to ensure  ⌦ so ⌫ that the 
manufacturing process Ö and its monitoring  ⌦ ensure compliance of ⌫ requires  the 
manufactured pressure equipment to co mply  with the technical documentation referred to in 
section  point  2 and with the requirements of the  ⌦ this ⌫ Directive which apply to it . 
⌦ 4. CE marking and EU d eclaration of conformity ⌫ 
4.1. The manufacturer, or his au thorized representative established within the Community,  
must  ⌦ shall ⌫ affix the CE marking to each item  ⌦ individual ⌫ of pressure equipment EN 101   EN and draw up a written declaration  of conformity  ⌦ that satisfies the applicable requirements 
of this Directive ⌫ . 
 
Ø new 
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 year s after the pressure equipment has been placed 
on the market. The EU declaration of conformi ty shall identify the pressure equipment for 
which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request. 
5. Authorised representative 
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised 
representative, on his behalf and under his respons ibility, provided that th ey are specified in 
the mandate. 
 
Ð 97/23/EC 
MODULE A1 (INTERNAL MANUFACTURI NG CHECKS WITH MONIT ORING OF THE FINAL 
ASSESSMENT ) 
In addition to the requirements of module A, the following applies.  
Final assessment must be performed by the manufacturer and monitored by means of 
unexpected visits by a notified body chosen by the manufacturer.  
During such visits, the notified body must:  
– establish that the manufacturer actually performs final assessment in  accordance with 
section 3.2 of Annex I,  
– take samples of pressure e quipment 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, o r have performed, all or part of the 
final assessment of the pressure equipment samples.  
Should one or more of the items of pressure  equipment not conform, the notified body must 
take appropriate measures.  
On the responsibility of  the notified body, the ma nufacturer must affix the former's 
identification number on each item of pressure equipment.  EN 102   EN  
Ø new 
2. MODULE A2:  INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT 
CHECKS AT RANDOM INTERVALS  
1. Internal production control plus final a ssessment performed by the manufacturer and 
monitored by means of unexpected visits by a notified body chosen by th e manufacturer is the 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in points 2, 3, 4, and 5, and ensure s and declares on his sole res ponsibility that the pressure 
equipment concerned satisfy the re quirements of this Directive. 
2. Technical documentation 
The manufacturer shall estab lish the technical documentation. The documentation shall make 
it possible to assess the conformity of the pressu re equipment with the relevant requirements, 
and shall include an adequate analysis and assessment of the risk(s). The technical 
documentation shall specify the applicable require ments and cover, as far as relevant for the 
assessment, the design, manufact ure and operation of the pressure equipment. The technical 
documentation shall contain, wherever appl icable, at least the following elements: 
– a general description of the pressure equipment; 
– conceptual design and manufacturing dr awings and schemes of components, 
sub-assemblies, circuits, etc.; 
– descriptions and explanations necessary for the understanding of those drawings 
and schemes and the operation of the pressure equipment; 
– a list of the harmonised standards the refe rences 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 st andards 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 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure compliance of  the manufactured pressure e quipment with the technical 
documentation referred to in point 2 and with the requirements of this Di rective that apply to 
it. 
4. Final assessment and pressure equipment checks 
The manufacturer shall perform a final assessmen t of the pressure equipment, monitored by 
means of unexpected visits by a notif ied body chosen by the manufacturer.  EN 103   EN The notified body shall carry out product checks or have them ca rried out at random intervals 
determined by the body, in order to verify the quali ty of the internal checks of the pressure 
equipment, taking into account inter alia the tec hnological 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 equipmen t performs within accept able limits, with a 
view to ensuring conformity of the pressure equipment. 
Should one or more of the items of pressure eq uipment or assembly not conform, the notified 
body shall take appropriate measures. 
The manufacturer shall, under the responsibility of the notif ied body, affix the notified body's 
identification number during th e manufacturing process.  
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affi x the CE marking to each individual pressure equipment 
that satisfies the applicable requirements of this Directive. 
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 year s after the pressure equipment has been placed 
on the market. The EU declaration of conformi ty shall identify the pressure equipment for 
which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request. 
6. Authorised representative 
The manufacturer's obligations set out in point 5 may be fulfilled by his authorised 
representative, on his behalf and under his respons ibility, provided that th ey are specified in 
the mandate. 
 
Ð 97/23/EC (adapted) 
3. MODULE B: (EC TYPE - ⌦ EU- TYPE  ⌫ EXAMINATION ) 
⌦ 3.1. EU-type examination – combination of  production type and design type ⌫ EN 104   EN  
Ð 97/23/EC 
1. This module describes the part of the procedure by which a notified body ascertains and 
attests that a representative ex ample of the production in questi on meets the provisions of the 
Directive which apply to it.  
2. The application for EC type -examination must be lodged by the manufacturer or by his 
authorized representative established within the Community with a single no tified body of his 
choice.  
 
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1. EU-type examination - combination of productio n type and 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 attest s that the technical design of the pressure 
equipment meets the requirements of this Directive. 
2. EU-type examination - combination of pr oduction type and design type shall consist 
of an assessment of the adequacy of the tec hnical design of the pressure equipment through 
examination of the technical documentation an d supporting evidence re ferred to in point 3, 
plus examination of specimens, representative of the production envisaged, of one or more 
critical parts of the pressure equipment. 
3. The manufacturer shall lodge an application for EU-type examination with a single 
notified body of his choice. 
 
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The application must  ⌦ shall ⌫ include: 
 
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– the name and address of the manufacturer and, if the application is lodged by the 
authorized representative, hi s name and address as well, ; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body, ; 
 
Ð 97/23/EC (adapted) 
– the technical documentation described in section 3.  
 
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The applicant must place at the disposal of the notified body a representative example of the 
production envisaged, hereinafter calle d «type». The notified body may reque st further 
examples should the test programme so require.  EN 105   EN A type may cover several versions of pressu re equipment provided that the differences 
between the versions do not a ffect the level of safety.  
 
Ð 97/23/EC (adapted) 
Ö new 
– 3. ⌦ the technical documentation. ⌫ The technical documentation must enable  
⌦ shall make it possible to ⌫ an assessment to be made of  the conformity of the 
pressure equipment with the ⌦ applicable ⌫ requirements of th e ⌦ this ⌫ 
Directive Ö and shall include an adequate analysis and assessment of the 
risk(s).  which apply to it. It must  ⌦ The technical documentation shall specify 
the applicable requirements and cover ⌫, as far as is  relevant for such  ⌦ the ⌫ 
assessment, cover  the design, manufacture and operat ion of the pressure equipment.  
⌦ The technical doc umentation shall ⌫ and contain ⌦ , wherever applicable, at 
least the following elements ⌫ : 
– a general description of the type  ⌦ pressure equipment ⌫ ,; 
– conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ 
of components, sub-assemblies, circuits, etc., ; 
 
Ð 97/23/EC (adapted) 
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– descriptions and explan ations necessary for an  ⌦ the ⌫ understanding of the  
⌦ those ⌫ said  drawings and diagrams  ⌦ schemes ⌫ and the operation of 
the pressure equipment, ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5  ⌦ the 
references of which have been published in the Official Journal of the 
European Union  ⌫, applied in full or in part, a nd descriptions of the solutions 
adopted to meet the essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ 
Directive where the  ⌦ those harmonised ⌫ standards referred to in Article 5  
have not been applied, . Ö In the event of partly a pplied harmonised standards, 
the technical documentation shall specify the parts which have been applied;  
 
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– 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 sections  
points  3.1.2 and 3.1.3 of Annex I. ; 
 
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– the specimens representative of the production envisaged;  EN 106   EN 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 specimen s 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 necessa ry, 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. 
 
Ð 97/23/EC (adapted) 
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4. The notified body must  ⌦ shall ⌫ : 
4.1. examine the technical documentation, verify  that the type has been manufactured in 
conformity with it and identify the component s designed in accordance with the relevant 
provisions of the stand ards referred to in Article 5, as we ll as those design ed without applying 
the provisions of  those standards  Ö and supporting evidence to assess the adequacy of the 
technical design of the pressure equipm ent and the manufacturing procedures  . 
In particular, the notified body must  ⌦ 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 a pproval for pressure equipment materials, 
and check the certificate issued by the material manufacturer in accordance with 
section  point  4.3 of Annex I, ; 
 
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– approve the procedures for the permanent jo ining of pressure equipment parts, or 
check that they have been previously  approved in accordan ce with section  point  3.1.2 
of Annex I, ; 
– verify that the personnel undertaking the pe rmanent joining of pressure equipment 
parts and the non-destructive tests are qualified or appr oved in accordance with 
sections  points  3.1.2 or 3.1.3 of Annex I. 
4.2. perform or have performed th e appropriate examinations and necessary tests to establish 
whether the solutions adopted  by the manufacturer meet th e essential requirements of the 
Directive where the standards referred to in Article 5 have not been applied.  EN 107   EN  
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4.2. verify that the specimen(s) have been manu factured in conformity with the technical 
documentation and identify the elements which ha ve been designed in accordance with the 
applicable provisions of the rele vant harmonised standards as we ll as the elements which have 
been designed using other relevant technical  specifications without applying the relevant 
provisions of those standards. 
 
Ð 97/23/EC (adapted) 
4.3. perform  or have performed the  ⌦ carry out ⌫ appropriate examinations and necessary 
tests to establish whether,  ⌦ to check ⌫ where  ⌦ whether when ⌫ the manufacturer has 
chosen to apply ⌦ the solutions in ⌫ the relevant ⌦ harmonised ⌫ standards, these have 
actually  been applied ⌦ correctly ⌫ . 
 
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4.4. carry out appropriate examinations to ch eck whether, where th e solutions in the 
relevant harmonised standards have not be en applied, the solutions adopted by the 
manufacturer applying other rele vant technical specifications meet the corresponding essential 
safety requirements of this Directive. 
4.5. agree with the manufacturer on a location where the examin ations and tests will be 
carried out.  
 
Ð 97/23/EC 
4.4. agree with the applicant th e location where the examinat ions and necessary tests are to be 
carried out.  
5. Where the type satisfies the provisions of th e Directive which apply to it, the notified body 
must issue an EC type -examination certificate to the applicant. The certificate, which should 
be valid for ten years and be renewable, must cont ain the name and address of the 
manufacturer, the conclusions of  the examination and the necessary data for identification of 
the approved type.  
A list of the relevant parts of the te chnical documentation must be annexed to  the certificate 
and a copy kept by the notified body.  
If the notified body refuses to issue an EC type -examination certificate to the manufacturer or 
to his authorized representative establishe d within the Community, that body must provide 
detailed reason s for such refusal. Provision must be made for an appeals procedure.  
6. The applicant must inform the notified body that holds the technical documentation 
concerning the EC type -examination certificate of all modifi cations to the approved pressure 
equipmen t; these are subject to additional approval wh ere they may affect conformity with the 
essential requirements or the prescribed conditio ns for use of the pressure equipment. This 
additional approval must be given in the form of an addition to the original E C type -
examination certificate.  EN 108   EN 7. Each notified body must communicate to the Member States the relevant information 
concerning EC type -examination certificates which it has withdrawn, and, on request, those it 
has issued.  
Each notified body must also comm unicate to the other notified bodies the relevant 
information concerning the EC type -examination certificates it has withdrawn or refused.  
8. The other notified bodies may receive copies of the EC type -examination certificates and/or 
their additions. The a nnexes to the certificates must be held at the disposal of the other 
notified bodies.  
9. The manufacturer, or his authorized represen tative established within the Community, must 
keep with the technical documentation copies of EC type -examination certifica tes and their 
additions for a period of ten years after th e last of the pressure  equipment has been 
manufactured.  
Where neither the manufacturer nor his authori zed representative is established within the 
Community, the obligation to keep the technical doc umentation available is the responsibility 
of the person who places the product on the Community market.  
 
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5. The notified body shall draw up an evalua tion report that r ecords the activities 
undertaken in accordance with point 4 and th eir outcomes. Without prejudice to its 
obligations vis-à-vis the notifyi ng authority, the notified body shall release the content of that 
report, in full or in part, only with  the agreement of the manufacturer. 
6. Where the type meets the requirements of this Directive, the no tified body shall issue 
an EU-type examination certificate – combinati on of production type and design type to the 
manufacturer. The certificate, which should be valid for 10 years and be renewable, shall 
contain the name and address of the manufactur er, the conclusions of the examination, the 
conditions (if any) for its validity and the n ecessary data for identif ication of the approved 
type. 
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 a nnexes shall contain all relevant information to allow the conformity 
of manufactured pressure equipment with the ex amined 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 examina tion certificate – comb ination of production 
type and design type and shall inform the applic ant accordingly, giving detailed reasons for its 
refusal. Provision shall be made for an appeals procedure.  
7. The notified body shall keep itself appr ised 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 no tified body shall inform the manufacturer 
accordingly. EN 109   EN The manufacturer shall inform the notified body that holds the technical documentation 
relating to the EU-type examin ation 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 notif ying authority concerning the EU-type 
examination certificates – combination of pr oduction type and desi gn type and/or any 
additions thereto which it has issued or wit hdrawn, and shall, periodically or upon request, 
make available to its notifying authorities the li st of certificates and/or  any additions thereto 
refused, suspended or otherwise restricted. 
Each notified body shall inform the other notif ied bodies concerning the EU-type examination 
certificates – combin ation of production  type and design type and/or any additions thereto 
which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, 
concerning the certificates and/or add itions thereto which it has issued. 
The Commission, the Member States and the ot her notified bodies may, on request, obtain a 
copy of the EU-type examination cert ificates – combination of production  type and design 
type and/or additions thereto. On request, th e Commission and the Member States may obtain 
a copy of the technical documentation and the re sults of the examinatio ns carried out by the 
notified body. The notified body shall keep a c opy of the EU-type examination certificate – 
combination of production  type and design type, its annexes and additions, as well as the 
technical file including the documentation subm itted 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 – 
combination of production  type and design type, its annexes and additions toge ther with the 
technical documentation at the disposal of the national authorities for 10 years after the 
pressure equipment has been placed on the market. 
10. The manufacturer's authorised representativ e may lodge the application referred to in 
point 3 and fulfil the obligations set out in point s 7 and 9, provided that they are specified in 
the mandate. 
 
Ð 97/23/EC (adapted) 
MODULE B1 3.2.  (EC DESIGN - ⌦ EU- TYPE  ⌫ EXAMINATION ) ⌦ – DESIGN TYPE  ⌫  
 
Ð 97/23/EC 
1. This modul e describes the part of the procedur e whereby a notified body ascertains and 
attests that the design of an item of pressure equipment meets the provisions of the Directive 
which apply to it.  
 
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1. EU-type examination – design type is the pa rt of a conformity assessment procedure 
in which a notified body examines the technical design of the pressure equipment and verifies EN 110   EN and attests that the technical design of the pr essure equipment meets the requirements of this 
Directive. 
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.  
 
Ð 97/23/EC (adapted) 
1. The experimental design me thod provided for in section  point  2.2.4 of Annex I may  
⌦ shall ⌫ not be used in the context of this module. 
23. The manufacturer, or his authorized representat ive established within the Community , 
must  ⌦ shall ⌫ lodge an application for EC design  ⌦ EU-type ⌫ examination ⌦ - 
design type ⌫ with a single notified body ⌦ of his choice ⌫ . 
The application must  ⌦ shall ⌫ include: 
 
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– the name and address of the manufacturer and, if the application is lodged by the 
authorized representative, hi s name and address as well, ; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body, ; 
 
Ð 97/23/EC (adapted) 
– the technical documentation described in section 3.  
 
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The application may cover sever al versions of the pressure equipment provided that the 
differences between the versions do not affect the level of safety.  
 
Ð 97/23/EC (adapted) 
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– 3. ⌦ the technical documentation. ⌫ The technical documentation must enable an  
⌦ shall make it possible to ⌫ assessment to be made of  the conformity of the 
pressure equipment with the ⌦ applicable ⌫ requirements of th e Directive which 
apply to it  Ö and shall include an adequate analysis and assessment of the risk(s)  . 
⌦ The technical documentation shall specif y the applicable requirements and cover 
⌫ It must , as far as is  relevant for such  ⌦ the ⌫ assessment, cover  the design, 
manufacture and operation of the pressure equipment.  ⌦ The technical 
documentation shall ⌫ and contain ⌦ , wherever applicable, at least the following 
elements ⌫ : 
– a general description of the pressure equipment, ; EN 111   EN – conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ 
of components, sub-assemblies, circuits, etc., ; 
– descriptions and explan ations necessary for an  ⌦ the ⌫ understanding of the 
said ⌦ those ⌫ drawings and diagrams  ⌦ schemes ⌫ and the operation of 
the pressure equipment, ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5  ⌦ the 
references of which have been published in the Official Journal of the 
European Union  ⌫, applied in full or in part, a nd descriptions of the solutions 
adopted to meet the essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ 
Directive where the  ⌦ those harmonised ⌫ standards referred to in Article 5  
⌦ have ⌫ not been applied. Ö In the event of partly applied harmonised 
standards, the technical doc umentation shall specify the parts which have been 
applied;  
 
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– results of design calculations made , examinations carried out, etc., ; 
– information regarding the qualifications or approva ls required under sections  
points  3.1.2 and 3.1.3 of Annex I. ; 
 
Ð 97/23/EC (adapted) 
Ö new 
– the necessary  supporting evidence for the adequacy of the ⌦ technical ⌫ design 
solution, . Ö This supporting evidence shall men tion any documents that have been 
used,  in particular where the ⌦ relevant harmonised ⌫ standards referred to i n 
Article 5  have not been applied in full; . the ⌦ This ⌫ supporting evidence must  
⌦ 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 ⌫ ,. 
 
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The application may cover several versions of  the pressure equipment provided that the 
differences between the versions do not affect the level of safety. 
 
Ð 97/23/EC (adapted) 
Ö new 
4. The notified body must  ⌦ shall ⌫: 
4.1. examine the technical documentation and identify the components which have been 
designed in accordance with the relevant provisions  of the standards referred to in Article 5, 
as well as those which have been designed with out applying the releva nt provisions of those 
standards.  Ö and supporting evidence to assess the ad equacy of the tec hnical design of the 
product.  EN 112   EN In particular, the notified body must  ⌦ shall ⌫: 
 
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– assess the materials where these are not in  conformity with the relevant harmonised 
standards or with a European approv al for pressure equipment materials, ; 
– approve the procedures for the permanent jo ining of pressure equipment parts, or 
check that they have been previously  approved in accordan ce with section  point  3.1.2 
of Annex I, . 
– verify that the personnel undertaking the pe rmanent joining of pressure equipment 
parts and the non -destructive tests are qualified or  approved in accordance with 
sections 3.1.2 and 3.1.3 of Annex I.  
 
Ð 97/23/EC (adapted) 
Ö new 
4.2. perform the necessary  ⌦ carry out appropriate ⌫ examinations to establish  
⌦ check ⌫ whether ⌦ where the manufacturer has chosen to apply ⌫ the solutions 
adopted by the manufacturer meet the essent ial requirements of the Directive where the 
standards referred to in Article 5  ⌦ in the relevant harmonised standards these ⌫ have not  
been applied Ö correctly  . 
4.3. perform the necessary  ⌦ carry out appropriate ⌫ examinations to establish  
⌦ check ⌫ whether, where the manufacturer has c hosen to apply the relevant standards, 
these h ave actually been applied  ⌦ solutions in the relevant harmonised standards have not 
been applied, the solutions adopted by the ma nufacturer meet the co rresponding essential 
safety requirements of this Directive ⌫ . 
 
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5. Where the design meets the prov isions of the Directive which apply to it, the notified body 
must issue an EC design -examination certificate to the applic ant. The certificate must contain 
the name and address of th e applicant, the conclusion s of the examination, conditions for its 
validity and the necessary data for id entification of the approved design.  
A list of the relevant parts of the technical documentation must be annexed to the certificate 
and a copy kept by the notified body.  
If the notified body refuses to issue an EC design -examination certificate to the manufacturer 
or to his authorized representative establishe d within the Community, that body must provide 
detailed reasons for such refusal. Prov ision must be made for an appeals pr ocedure.  
6. The applicant must inform the notified body that holds the technical documentation 
concerning the EC design -examination certificate of all modifi cations to the approved design; 
these are subject to additional approval where such changes may aff ect the conformity of the 
pressure equipment with the essential require ments of the Directiv e or the prescribed 
conditions for use of the equipment. This addition al approval must be given in the form of an 
addition to the original EC design -examination cer tificate.  EN 113   EN 7. Each notified body must communicate to the Member States the relevant information 
concerning EC design -examination certificates which it ha s withdrawn, and, on request, those 
it has issued.  
Each notified body must also  communicate to the other  notified bodies the relevant 
information concerning the EC design -examination certificates it has withdrawn or refused.  
8. The other notified bodies may on request ob tain the relevant information concerning:  
– the EC design -examination certificates and addi tions granted,  
– the EC design -examination certificates and additions withdrawn.  
9. The manufacturer, or his authorized represen tative established within the Community, must 
keep with the technical documentation referr ed to in section 3 copies of EC design -
examination certificates and their additions for a period of ten years after the last of the 
pressure equipment has been manufactured.  
Where neither the manufacturer nor his authori zed representative is established within the 
Community, the obligation to ke ep the technical documentation available is the responsibility 
of the person who places the product on the Community market.  
 
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5. The notified body shall draw up an evalua tion report that r ecords the activities 
undertaken in accordance with point 4 and th eir outcomes. Without prejudice to its 
obligations vis-à-vis the notifyi ng authorities, the notified body shall release the content of 
that report, in full or in part, only with the agreement of the manufacturer. 
6. Where the design meets the requirements of this Directive, the notified body shall 
issue an EU-type examination certificate - design  type to the manufactur er. The certificate, 
which should be valid for 10 years and be renewa ble, shall contain the name and address of 
the manufacturer, the conclusions of the examina tion, the conditions (if any) for its validity 
and the necessary data for iden tification of the approved design. 
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 a nnexes shall contain all relevant information to allow the conformity 
of manufactured pressure equipm ent 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 examinat ion certificate - design t ype and shall inform 
the applicant accordingly, giving detailed reasons for its refusal.  
7. The notified body shall keep itself appr ised 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 no tified body shall inform the manufacturer 
accordingly. EN 114   EN 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 info rm its notifying authoritie s concerning the EU-type 
examination certificates - design type and/or any additions thereto wh ich it has issued or 
withdrawn, and shall, periodically or upon reques t, make available to its notifying authorities 
the list of certificates and/or  any additions thereto refused, su spended or otherwise restricted. 
Each notified body shall inform the other notif ied 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 ot her 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 th e Member States may obtai n a copy of the technical 
documentation and the results of the examin ations 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 ex amination certificate - design  
type, its annexes and additions t ogether with the technical docu mentation at the disposal of 
the national authorities for 10 years after th e pressure equipment has been placed on the 
market. 
10. The manufacturer's authorised representativ e may lodge the application referred to in 
point 3 and fulfil the obligations set out in point s 7 and 9, provided that they are specified in 
the mandate. 
 
Ð 97/23/EC (adapted) 
4. MODULE C12: (CONFORMITY TO TYPE ) ⌦ BASED ON INTERNAL PRODUCTION CONTROL 
PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS ⌫ 
 
Ð 97/23/EC  
1. This module describes that part of the procedure whereby the manufacturer, or his 
authorized representative established within  the Community, ensures and declares that 
pressure equipment is in conformity with the type as described in th e EC type -examination 
certificate and satisfies the requi rements of the Directive which apply to it. The manufacturer, 
or his authorized representative established wi thin the Community, must affix the CE marking 
to each item of pressure equipment and draw up a written declara tion of conformity.  EN 115   EN  
Ø new 
1. Conformity to type based on internal pr oduction 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 are in 
conformity with the type described in the EU -type examination certificate and satisfy the 
requirements of this Directive that apply to it. 
 
Ð 97/23/EC (adapted) 
Ö new 
2. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ take all measures necessary to ensure  ⌦ so ⌫ that the 
manufacturing process Ö and its monitoring ensure conformity of  requires  the 
manufactured pressure equipment to comply  with the type as  described in the EC  type - 
⌦ EU-type ⌫ examination certificate and with the requirements of the  ⌦ this ⌫ Directive 
which  ⌦ that ⌫ apply to it  ⌦ them ⌫ . 
 
Ð 97/23/EC 
3. The manufacturer, or his a uthorized representative established within the Community, must 
keep a copy of the declaration of conformity for a period of ten years af ter the last of the 
pressure equipment has been manufactured.  
Where neither the manufacturer nor his authorized represe ntative is established within the 
Community, the obligation to keep the technical documentation available is the responsibility 
of the person who places the pressure equipment on the Community market.  
4. Final assessment must be subject to monitoring in th e form of unexpected visits by a 
notified body chosen by the manufacturer.  
During such visits, the notified body must:  
– establish that the manufacturer actually pe rforms final assessment in accordance with 
section 3.2 of Annex I,  
– take samples of pressure eq uipment at the manufacturing or storage premises in order 
to conduct checks. The notified body must a ssess the number of items of equipment 
to sample and whether it is necessary to pe rform, or have performed, all or part of 
final assessment on the pressure  equipment samples.  
Should one or more of the items of pressure  equipment not conform, the notified body must 
take appropriate measures.  
On the responsibility of the notified body, the manufactu rer must affix the former's 
identification number on each item  of pressure equipment.  EN 116   EN  
Ø new 
3. Final assessment and pressure equipment checks 
A notified body, chosen by the ma nufacturer, 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 ch ecks on the pressure eq uipment, taking into  account inter alia 
the technological complexity of the pressu re equipment and the quantity of production.  
The notified body shall establish that the manufactur er actually performs final assessment in 
accordance with point 3.2 of Annex I. 
An adequate sample of the final pressure equi pment, taken on site by the notified body before 
the placing on the market, shall be examined and appropriate tests as id entified by the relevant 
parts of the harmonised standards, and/or equivalent tests appl ying other technical 
specifications, shall be carried out to check the conformity of the pressu re 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 a cceptable 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 equipmen t performs within accept able limits, with a 
view to ensuring conformity of the pressure equipment. 
Where the tests are carried out by a notif ied body, the manufacturer shall, under the 
responsibility of the notified body, affix the no tified body's identification number during the 
manufacturing process. 
4. CE marking and EU decl aration of conformity 
4.1. The manufacturer shall affix the CE marking to each indivi dual 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. 
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 mark et. The EU declaration of conformity shall 
identify the pressure equipment mo del for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
5. Authorised representative EN 117   EN The manufacturer's obligations set out in point 4 may be fulfilled by his authorised 
representative, on his behalf and under his respons ibility, provided that th ey are specified in 
the mandate. 
 
Ð 97/23/EC (adapted) 
5. MODULE D: ( ⌦ CONFORMITY TO TYPE BASED ON  ⌫ PRODUCTION  QUALITY 
ASSURANCE ) ⌦ OF THE PRODUCTION PROCESS  ⌫ 
 
Ð 97/23/EC  
1. This module describes the procedure wher eby the manufacturer who satisfies the 
obligations of section 2 ensures and declares that  the pressure equipm ent concerned is in 
conformity with the type described in the EC type -examination certificate or EC design -
examination certificate and satisfies the requirem ents of the Directive which apply to it. The 
manufacturer, or his authorized re presentative established within  the Community, must affix 
the CE marking to each item of pressure eq uipment and draw up a wr itten declaration of 
conformity. The CE marking must be accomp anied by the identification number of the 
notified body responsible fo r surveillance as spec ified in section 4.  
 
Ø new 
1. Conformity to type based on quality assuranc e 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 confor mity with the type described in the EU-type 
examination certificate and satisfies the require ments of this Directive that apply to it. 
 
Ð 97/23/EC (adapted) 
2. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ operate an approved quality system for production, final 
⌦ product ⌫ inspection and testing ⌦ of the pressure equipment concerned ⌫ as 
specified in section  point  3 and ⌦ shall ⌫ be subject to surveillance  as specified in section  
point  4. 
3. Quality system 
3.1. The manufacturer mu st ⌦ shall ⌫ lodge an application for assessment of his quality 
system with a  ⌦ the ⌫ notified body of his choice ⌦ for the pressure equipment 
concerned ⌫ . 
The application must  ⌦ shall ⌫ include: 
 
Ø new 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; EN 118   EN – a written declaration that the same applic ation has not been lodged with any other 
notified body; 
 
Ð 97/23/EC (adapted) 
Ö new 
– all relevant information on the pressure equipment Ö type envisaged  concerned ,; 
– the documentation concerning the quality system, ; 
– the technical documentation for  ⌦ of ⌫ the approved type and a copy of the EC 
type- ⌦ EU-type ⌫ examination certificate or EC design -examination certificate . 
3.2. The quality system mus t ⌦ shall ⌫ ensure ⌦ that ⌫ compliance of  the pressure 
equipment ⌦ is in conformity ⌫ with the type described in the EC type - ⌦ EU-type ⌫ 
examination certificate or EC design -examination certificate and  ⌦ and comply ⌫ with the 
requirements of the  ⌦ this ⌫ Directive which  ⌦ that ⌫ apply to it. 
All the elements, requirements and pr ovisions adopted by the manufacturer must  ⌦ shall ⌫ 
be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must
 ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It must  ⌦ shall ⌫ contain , in particular,  ⌦ contain ⌫ an adequate description of: 
 
Ð 97/23/EC 
– the quality objectives and the organizational structure, responsibi lities and powers of 
the management with regard to the quality of the pressure equipment, ; 
 
Ð 97/23/EC (adapted) 
– the ⌦ corresponding ⌫ manufacturing, quality cont rol and quality assurance 
techniques, processes and systematic measures  ⌦ actions ⌫ t h a t  w i l l  b e  u s e d ,  
particularly the procedures used for the permanent joining of parts as approved in 
accordance with section  point  3.1.2 of Annex I, ; 
 
Ð 97/23/EC 
– the examinations and tests that will be  carried out before, during and after 
manufacture, and the frequency with which they will be carried out, ; 
 
Ð 97/23/EC (adapted) 
– the quality records, such as inspection repor ts and test data, ca libration 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 sections  points  3.1.2 and 3.1.3 of Annex I, 
⌦ etc. and ⌫ EN 119   EN  
Ð 97/23/EC 
– the means of monitoring the achievement of the required quality and the effective 
operation of the quality system. 
 
Ð 97/23/EC (adapted) 
3.3. The notified body must  ⌦ shall ⌫ assess the quality system to determine whether it 
satisfies the requirements referred to in 3.2.  
 
Ø new 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised standard. 
 
Ð 97/23/EC (adapted) 
Ö new 
The elements of the quality system which conform to the relevant harmonized standard are 
presumed to comply with the corres ponding requirements referred to in 3.2.  
⌦ In addition to experience in quality management systems, ⌫ Tthe auditing team must  
⌦ shall ⌫ have at least one member with experience of assessing  ⌦ evaluation in ⌫ the 
⌦ relevant ⌫ pressure equipment ⌦ field and pressure equipment ⌫ technology 
concerned Ö , and knowledge of the applicable  requirements of this Directive  . The 
assessment procedure must  ⌦ audit shall ⌫ include an inspection visit to the manufacturer's 
premises. 
 
Ø new 
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 examin ations with a view to  ensuring compliance of 
the product with those requirements. 
 
Ð 97/23/EC (adapted) 
The decision must  ⌦ shall ⌫ be notified to the manufact urer. The notification must  
⌦ shall ⌫ contain the conclusions of the examination  ⌦ audit ⌫ and the reasoned 
assessment decision. Provision must be  made for an appeals procedure.   
3.4. The manufacturer must  ⌦ shall ⌫ undertake to fulfil the oblig ations arising out of the 
quality system as approved and to ensure  ⌦ maintain it so ⌫ that it remains satisfactory  
⌦ adequate ⌫ and efficient. 
3.5. The manufacturer, or his authorized repres entative established within the Community,  
must inform  ⌦ shall keep ⌫ the notified body that has approved the quality system 
⌦ informed ⌫ of any intended adjustment  ⌦ change ⌫ to the quality system. EN 120   EN The notified body must  ⌦ shall ⌫ assess  ⌦ evaluate ⌫ the proposed changes and decide 
whether the amended  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in point  3.2 or whether a reassessment is required  ⌦ necessary ⌫ . 
It must  ⌦ shall ⌫ notify its decision to  the manufacturer ⌦ of its decision ⌫. The 
notification must  ⌦ shall ⌫ contain the conclusions of the examination and the reasoned 
assessment decision. 
 
Ð 97/23/EC 
4. Surveillance under the responsibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
 
Ð 97/23/EC (adapted) 
4.2. The manufacturer must  ⌦ shall, for assessment purposes, ⌫ allow the notified body 
access for inspection purposes  to the locations of  manufacture, inspecti on, testing and storage 
⌦ sites ⌫ and ⌦ shall ⌫ provide it with all necessary  information, in particular: 
– the quality system documentation, ; 
– the quality records, such as inspection reports and test data, calibration data, 
⌦ qualification ⌫ reports concerning the qualifications  of the personnel concerned, 
etc. 
4.3. The notified body must  ⌦ 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  ⌦ shall ⌫ be such that a full 
reassessment is carried out every three years. 
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 must  
⌦ shall ⌫ be considered in the visit control system: 
– the category of the ⌦ pressure ⌫ equipment, ; 
 
Ð 97/23/EC 
– the results of previous  surveillance visits, ; 
 
Ð 97/23/EC (adapted) 
– the need to follow up corrective action  ⌦ actions ⌫ ,; 
 
Ð 97/23/EC 
– special conditions linked to the approval of the system, where applicable, ; EN 121   EN – significant changes in manufacturing organiz sation, policy or techniques. 
 
Ð 97/23/EC (adapted) 
During such visits the notified body may, if necessary, carry out ⌦ product tests ⌫ or have 
⌦ them ⌫ carried out tests  ⌦ in order ⌫ to verify that the quality system is functioning 
correctly. The notified body must  ⌦ shall ⌫ provide the manufactur er with a visit report 
and, if a test has taken place  ⌦ tests have been carried out ⌫ , with a test report. 
 
Ø new 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 3.1, the latt er'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. 
5.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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 equipmen t model for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
 
Ð 97/23/EC (adapted) 
Ö new 
56. The manufacturer must  ⌦ shall ⌫, for a period of  ⌦ ending ⌫ ten 10 years after the 
last of the  pressure equipment has been manufactured  Ö placed on the market  , hold  
⌦ keep ⌫ at the disposal of the national authorities: 
 
Ð 97/23/EC  
– the documentation referred to in the second indent of  point  3.1; 
 
Ð 97/23/EC (adapted) 
Ö new 
– the adjustments  ⌦ change ⌫ referred to in the second paragraph of  point  3.45 ⌦ , 
as approved ⌫ ;,  
– the decisions and reports from  ⌦ of ⌫ the notified body which are  referred to in 
the last paragraph of  points  3.3, the last paragraph of  3.45, and in  4.3 and 4.4. 
67. Each notified body must  communicate  ⌦ shall inform ⌫ to the Member States the 
relevant information concerning  Ö its notifying authorities of  the quality system approvals 
which it has  ⌦ issued or ⌫ withdrawn, and ⌦ shall ⌫ Ö , periodically or  , on  EN 122   EN ⌦ upon ⌫ request, those it has issued  Ö make available to its notifying authorities the list 
of quality system approvals refused, suspended or otherwise restricted  . 
Each notified body must  ⌦ shall ⌫ also communicate to  ⌦ inform ⌫ the other notified 
bodies the relevant information concerning  ⌦ of ⌫ the quality system approvals 
⌦ which ⌫ it has ⌦ refused, suspended, ⌫ withdrawn or refused  Ö otherwise restricted, 
and, upon request, of quality system approvals which it has issued  . 
 
Ø new 
8. Authorised representative 
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. 
 
Ð 97/23/EC (adapted) 
6. MODULE D1:  (PRODUCTION  QUALITY ASSURANCE ) ⌦ OF THE PRODUCTION PROCESS  ⌫ 
 
Ð 97/23/EC  
1. This module describes the proce dure whereby the manufacturer w ho satisfies the 
obligations of section 3 ensures and declares th at the items of pressure equipment concerned 
satisfy the requirements of the Directive whic h apply to them. The manufacturer, or his 
authorized representative established within the Community , must affix the CE marking to 
each item of pressure equipment and draw up a written declaration of conformity. The CE 
marking must be accompanied by the identifica tion number of the notified body responsible 
for surveillance as specified in section 5.  
 
Ø new 
1. Quality assurance of the production proce ss 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 respons ibility that the pr essure equipment concerned satisfy the 
requirements of this Directive that apply to it. 
 
Ð 97/23/EC (adapted) 
Ö new 
2. The manufacturer must draw up the  tTechnical documentation described below.  
Ö The manufacturer shall establ ish the technical documentation.  The technical  
documentation must  ⌦ shall ⌫ enable  ⌦ make it possible to assess ⌫ an assessment  to be 
made of  the conformity of the pressure equipment with the ⌦ relevant ⌫ requirements of 
the Directive which apply to it  Ö and shall include an adequate analysis and assessment of the 
risk(s)  . It must,  Ö The technical documentation shall specify the applicable 
requirements  ⌦ and cover, ⌫ as far as is  relevant for such  ⌦ the ⌫ assessment, cover  
the design, manufacture and operati on of the pressure equipment  ⌦ product. The technical EN 123   EN documentation shall, wherever applicable, ⌫ and ⌦ contain at least the following 
elements ⌫ : 
 
Ð 97/23/EC 
– a general description of the pressure equipment , ; 
 
Ð 97/23/EC (adapted) 
Ö new 
– conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ of 
components, sub-assemblies, circuits, etc., ; 
– descriptions and explanations necessary for an understanding of the  ⌦ those ⌫ 
said drawings and diagrams  ⌦ schemes ⌫ and the operation of the pressure 
equipment , ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5  ⌦ the references of 
which have been published in the Official Journal of the European Union  ⌫, 
applied in full or in part, and descripti ons of the solutions adopted to meet the 
essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ Directive where the  ⌦ those 
harmonised ⌫ standards referred to in Article 5  have not been applied, . Ö In the 
event of partly applied harmonised sta ndards, the technical documentation shall 
specify the parts which have been applied;  
– results of design calculations made , examinations carried out, etc., ⌦ and ⌫ 
– test reports. 
 
Ø new 
3. The manufacturer shall keep the technica l documentation at th e disposal of the 
relevant national authorities for 10 years after the pressure equipment has been placed on the 
market. 
 
Ð 97/23/EC (adapted) 
34. ⌦ Manufacturing ⌫ 
The manufacturer mu st ⌦ shall ⌫ operate an approved quality system for production, final 
⌦ product ⌫ inspection and testing ⌦ of the pressure equipment concerned ⌫ as 
specified in section 4  point 5 , and ⌦ shall ⌫ be subject to surveillance as specified in 
section 5  point 6 .  
45. Quality system 
45.1. The manufacturer must  ⌦ shall ⌫ lodge an application for assessment of his quality 
system with a  ⌦ the ⌫ notified body of his choice ⌦ for the pressure equipment 
concerned ⌫ . 
The application must  ⌦ shall ⌫ include: EN 124   EN  
Ø new 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body; 
 
Ð 97/23/EC (adapted) 
– all relevant information on the pressure equipment ⌦ type envisaged ⌫ 
concerned ,; 
– the documentation concerning the quality system. ; 
 
Ø new 
– the technical documentation referred to in point 2. 
 
Ð 97/23/EC (adapted) 
45.2. The quality system must  ⌦ shall ⌫ ensure compliance of the pressure equipment with 
the requirements of the  ⌦ this ⌫ Directive which  ⌦ that ⌫ apply to it. 
All the elements, requirements and pr ovisions adopted by the manufacturer must  ⌦ shall ⌫ 
be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation m
ust ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It must  ⌦ shall, in particular, ⌫ contain in particular  an adequate description of: 
 
Ð 97/23/EC 
– the quality objectives and the organizational structure, responsibi lities and powers of 
the management with regard to the quality of the pressure equipment, ; 
 
Ð 97/23/EC (adapted) 
– the ⌦ corresponding ⌫ manufacturing, quality cont rol and quality assurance 
techniques, processes and systematic measur es that will be used, particularly the 
procedures used for the permanent joining of parts as approved in accordance with 
section  point  3.1.2 of Annex I, ;  
 
Ð 97/23/EC 
– the examinations and tests that will be  carried out before, during and after 
manufacture, and the frequency with which they will be carried out, ; EN 125   EN  
Ð 97/23/EC (adapted) 
Ö new 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the qualifications or approvals of the personnel concerned, particularly 
those of the personnel undertaking the perman ent joining of parts in accordance with 
section  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. 
45.3. The notified body must  ⌦ shall ⌫ assess the quality system to determine whether it 
satisfies the requirements referred to in 4 5.2. The elements of the quality system which 
conform to the relevant harmoni sed standard are presumed to comply with the corresponding 
requirements referred to in 4 5.2. 
⌦ In addition to experience in quality management systems, ⌫ Tthe auditing team must  
⌦ shall ⌫ have at least one member with experience of assessing  ⌦ evaluation in ⌫ the 
pressure equipment technology concerned Ö , and the knowledge of the applicable 
requirements of this Directive  . The assessment procedure  ⌦ audit ⌫ must  ⌦ shall ⌫ 
include an inspection  ⌦ assessment ⌫ visit to the manufacturer's premises. 
 
Ø new 
The auditing team shall review the technical docu mentation referred to in  point 2 in order to 
verify the manufacturer's ability to identify the re levant requirements of this Directive and to 
carry out the necessary examinations with a view to ensuring compliance of the pressure 
equipment with those requirements. 
 
Ð 97/23/EC (adapted) 
The decision must  ⌦ shall ⌫ be notified to the manufact urer. The notification must  
⌦ shall ⌫ contain the conclusions of the examination  ⌦ audit ⌫ and the reasoned 
assessment decision. Provision must be ma de for an appeals procedure.   
45.4. The manufacturer must  ⌦ shall ⌫ undertake to fulfil the obligations arising out of the 
quality system as approved and to ensure  ⌦ maintain it so ⌫ that it remains s atisfactory  
⌦ adequate ⌫ and efficient. 
5.5. The manufacturer, or his authorized repres entative established within the Community, 
must  inform  ⌦ shall keep ⌫ the notified body that has approved the quality system 
⌦ informed ⌫ of any intended adjustment  ⌦ change ⌫ to the quality system. 
The notified body must assess  ⌦ shall evaluate ⌫ the ⌦ any ⌫ proposed changes and 
decide whether the amended  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ 
satisfy the requirements referred to in point  45.2 or whether a reas sessment is required  
⌦ necessary ⌫ . EN 126   EN If must  ⌦ shall ⌫ notify its decision to  the manufacturer ⌦ of its decision ⌫ . The 
notification must  ⌦ shall ⌫ contain the conclusions of the examination and the reasoned 
assessment decision. 
 
Ð 97/23/EC 
56. Surveillance under the responsibil ity of the notified body 
56.1. The purpose of surveillance is to make su re that the manufactur er duly fulfils the 
obligations arising out of th e approved quality system. 
 
Ð 97/23/EC (adapted) 
56.2. The manufacturer must  ⌦ shall, for assessment purposes, ⌫ allow the notified body 
access for inspection purposes  to the locations of  manufacture, inspecti on, testing and storage 
⌦ sites ⌫ and ⌦ shall ⌫ provide it with all necessary  information, in particular: 
– the quality system documentation, ; 
 
Ø new 
– the technical documentation re ferred to in point 2; 
 
Ð 97/23/EC (adapted) 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the  qualifications  ⌦ reports ⌫ of the personnel concerned, etc. 
56.3. The notified body must  ⌦ 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  ⌦ shall ⌫ be such that a full 
reassessment is carried out every three years. 
56.4. In addition the notified body may pay unexpect ed visits to the manufacturer. The need 
for such additional visits, and the frequency ther eof, will be determined on the basis of a visit 
control system operated by the notified body. In particular, the following factors must  
⌦ shall ⌫ be considered in the visit control system: 
– the category of the ⌦ pressure ⌫ equipment, ; 
 
Ð 97/23/EC 
– 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 organiz sation, policy or techniques. EN 127   EN  
Ð 97/23/EC (adapted) 
During such visits the notified body may, if necessary, carry out or have carried out  
⌦ product ⌫ tests ⌦ , or have them carried out, in order ⌫ to verify that the quality 
system is functioning corre ctly. The notified body must  ⌦ shall ⌫ provide the manufacturer 
with a visit report and, if a test  has t aken place  ⌦ tests have been carried out ⌫ , with a test 
report. 
 
Ø new 
7. CE marking and EU decl aration of conformity 
7.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 5.1, the latt er's identification number to each individual 
pressure equipment that satisfies the app licable requirements of this Directive. 
7.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
 
Ð 97/23/EC (adapted) 
Ö new 
68. The manufacturer must  ⌦ shall ⌫, for a period of  ⌦ ending ⌫ ten 10 years after the 
last of the  pressure equipment has been manufactured  Ö placed on the market  , hold  
⌦ keep ⌫ at the disposal of the national authorities: 
– the technical documentation referred to in section 2,  
 
Ð 97/23/EC 
– the documentation referred to in the second indent of  point  45.1,; 
 
Ð 97/23/EC (adapted) 
Ö new 
– the adjustments  ⌦ change ⌫ referred to in the second paragraph of  point  4.45.5,; 
– the decisions and reports from  ⌦ of ⌫ the notified body which are  referred to in 
the last paragraph of  points  4.3, the last paragraph of  4.45.5, and in  56.3 and 5 6.4. 
79. Each notified body must  communicate  ⌦ shall inform ⌫ to the Member States the 
relevant information concerning  Ö its notifying authorities of  the quality system approvals 
which it has  ⌦ issued or ⌫ withdrawn, and ⌦ shall ⌫ Ö periodically  , ⌦ or ⌫ on 
⌦ upon ⌫ request, those it has issued  Ö make available to its notifying authorities the list 
of quality system approvals refused, suspended or otherwise restricted  . EN 128   EN Each notified body must also communicate  ⌦ shall inform ⌫ to the other notified bodies 
the relevant information concerning  the ⌦ of ⌫ quality system approvals ⌦ which ⌫ it 
has ⌦ refused, suspended, or ⌫ withdrawn or refused  Ö , and upon request, of quality 
system approvals which it has issued  . 
 
Ø new 
10. Authorised representative 
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. 
 
Ð 97/23/EC (adapted) 
7. MODULE E: (⌦ CONFORMITY TO TYPE BASED ON  ⌫ PRODUCT  ⌦ PRESSURE 
EQUIPMENT  ⌫ QUALITY ASSURANCE ) 
 
Ð 97/23/EC 
1. This module describes the procedure whereby the ma nufacturer who satisfies the 
obligations of section 2 ensures and declares that  the pressure equipment is in conformity with 
the type as described in the EC type -examination certificate and satisfies the requirements of 
the Directive which apply to it. The  manufacturer, or his authori zed representative established 
within the Community, must affix the CE marking to each product and draw up a written 
declaration of conformity. The CE marking must be accompanied by the identification 
number of the notified bod y responsible for surveillance as specified in section 4.  
 
Ø new 
1. Conformity to type based on pressure equi pment quality assurance is that part of a 
conformity assessment procedure whereby the ma nufacturer 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. 
 
Ð 97/23/EC (adapted) 
Ö new 
2. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ operate an approved quality sy stem for the final pressure 
equipment  ⌦ product ⌫ inspection and testing ⌦ of the pressure equipment concerned ⌫ 
as specified in section  point  3 and ⌦ shall ⌫ be subject to surveillance as specified in 
section  point  4. EN 129   EN 3. Quality system 
3.1. The manufacturer must  ⌦ shall ⌫ lodge an application for assessment of his quality 
system for the pressure equipment  with a  ⌦ the ⌫ notified body of his choice ⌦ , for the 
pressure equipment concerned ⌫. 
The application must  ⌦ shall ⌫ include: 
 
Ø new 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body; 
 
Ð 97/23/EC (adapted) 
– all relevant information on the pressure equipment ⌦ type envisaged ⌫ 
concerned ,; 
– the documentation concerning the quality system , ; 
– the technical documentation for  ⌦ of ⌫ the approved type and a copy of the EC 
type- ⌦ EU-type ⌫ examination certificate. 
3.2. Under the quality syst em, each item of pressure equipment must be examined and 
appropriate tests as set out in the relevant stan dard(s) referred to in Article 5, or equivalent 
tests, particularly final assessment as referred to in section 3.2 of Annex I, must be carried out 
in order to ensure its conformity with the requ irements of the Directive which apply to it.   
 
Ø new 
The quality system shall ensure compliance of the products with the type described in the 
EU-type examination certificate and with the ap plicable requirements of this Directive. 
 
Ð 97/23/EC (adapted) 
All the elements, requirements and pr ovisions adopted by the manufacturer must  ⌦ shall ⌫ 
be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must
 ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It must  ⌦ shall, in particular, ⌫ contain in particular  an adequate description of: 
– the quality objectives  and the organiz sational structure, res ponsibilities and powers 
of the management with regard to the  ⌦ product ⌫ quality of the pressure 
equip ment ,; 
– the examinations and tests to  ⌦ that will ⌫ be carried out after manufacture , ; EN 130   EN  
Ð 97/23/EC 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the qualifications or approvals of the personnel concerned, particularly 
those of the personnel unde rtaking the perman ent joining of parts and the non-
destructive tests in accordance with sections  points  3.1.2 and 3.1.3 of Annex I. ; 
– the means of monitoring the effectiv e operation of the quality system, . 
 
Ð 97/23/EC (adapted) 
Ö new 
3.3. The notified body must  ⌦ shall ⌫ assess the quality system to determine whether it 
satisfies the requirements referred to in 3.2. The  elements of the quality system which 
conform to the relevant harmonized standard are presumed to comply with the corresponding 
requirements referred to in 3.2.  Ö It shall presume conformity  with those requirements in 
respect of the elements of  the quality system that comply with the corresponding 
specifications of the national standard that implements the relevant harmonised standard 
and/or technical specification.  
⌦ In addition to experience in quality management systems, ⌫ Tthe auditing team must  
⌦ shall ⌫ have at least one member with experience of assessing  ⌦ evaluation in the 
relevant ⌫ the  pressure equipment ⌦ field and pressure equipment ⌫ technology 
concerned Ö and knowledge of the applicable requirements of this Directive  . The 
assessment procedure  must  ⌦ audit shall ⌫ include an inspection  ⌦ assessment ⌫ visit to 
the manufacturer's premises. 
 
Ø new 
The auditing team shall review the technical documentation referred to in point 3.1, fifth 
indent, in order to verify the manufacturer's abi lity 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. 
 
Ð 97/23/EC (adapted) 
The decision must  ⌦ shall ⌫ be notified to the manufact urer. The notification must  
⌦ shall ⌫ contain the conclusions of the examination  ⌦ audit ⌫ and the reasoned 
assessment decision. 
3.4. The manufacturer must  ⌦ shall ⌫ undertake to discharge  ⌦ fulfil ⌫ the obligations 
arising from  ⌦ out of ⌫ the quality system as approved and to ensure  ⌦ maintain it so ⌫ 
that it remains satisfactory  ⌦ adequate ⌫ and efficient. 
3.5. The manufacturer, or his authorized repres entative established within the Community, 
must inform  ⌦ shall keep ⌫ the notified body which  ⌦ that ⌫ has approved the quality 
system ⌦ informed ⌫ of any intended adjustment  ⌦ change ⌫ to the quality system. EN 131   EN The notified body must assess  ⌦ shall evaluate any ⌫ the proposed changes and decide 
whether the modified quality system will still  ⌦ continue to ⌫ satisfy the requirements 
referred to in point  3.2 or whether a reassessment is required  ⌦ necessary ⌫ . 
It must  ⌦ shall ⌫ notify its decision to  the manufacturer ⌦ of its decision ⌫ . The 
notification must  ⌦ shall ⌫ contain the conclusions of the examination and the reasoned 
assessment decision. 
 
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4. Surveillance under the responsibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
 
Ð 97/23/EC (adapted) 
4.2. The manufacturer must  ⌦ shall, for assessment purposes, ⌫ allow the notified body 
access for inspection purposes to the locations of ⌦ to the manufacture, ⌫ inspection, 
testing and storage ⌦ sites ⌫ and ⌦ shall ⌫ provide it with all ne cessary information, in 
particular: 
 
Ð 97/23/EC 
– the quality system documentation, ; 
– the technical documentation, ; 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the qualifications of  the personnel concerned, etc. 
 
Ð 97/23/EC (adapted) 
4.3. The notified body must  ⌦ 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 mu st be such that a full reassessment is carried 
out every three years. 
 
Ð 97/23/EC 
4.4. In addition the notified body may pay unexpected visits to the manufacturer.  
 
Ð 97/23/EC (adapted) 
The need for such additional visi ts, and the frequency thereof, will be determined on the basis 
of a visit control system operated by the no tified body. In particular, the following factors 
must  ⌦ shall ⌫ be considered in the visit control system: 
– the category of the ⌦ pressure ⌫ equipment, ; EN 132   EN – the results of previous  surveillance visits, ; 
– the need to follow up corrective action  ⌦ actions ⌫ ,; 
 
Ð 97/23/EC 
– special conditions linked to the approval of the system, where applicable, ; 
– significant changes in manufacturing organiz sation, policy or techniques. 
 
Ð 97/23/EC (adapted) 
During such visits, the notified body may, if necessary, carry out or have carried out  
⌦ product ⌫ tests ⌦ , or have them carried out, in order ⌫ to verify that the quality 
system is functioning corre ctly. The notified body must  ⌦ shall ⌫ provide the manufacturer 
with a visit report and, if a test has taken place  ⌦ tests have been carried out ⌫ , with a test 
report. 
 
Ø new 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 3.1, the latt er'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. 
5.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
 
Ð 97/23/EC (adapted) 
Ö new 
56. The manufacturer must  ⌦ shall ⌫, for a period of  ⌦ ending ⌫ ten 10 years after the 
last of the  pressure equipment has been manufactured  Ö placed on the market  , hold  
⌦ keep ⌫ at the disposal of the national authorities: 
– the documentation referred to in the second indent of  point  3.1,; 
– the adjustments  ⌦ change ⌫ referred to in the second paragraph of  point  3.45, 
⌦ as approved, ⌫,; 
– the decisions and reports from the notifie d body which are referred to in the last 
paragraph of  points  3.3, the last paragraph of  3.45, and in  4.3 and 4.4. EN 133   EN 67. Each notified body must  ⌦ shall ⌫ communicate to the Member States the relevant 
informat ion concerning the  Ö inform its notifying authorities of  quality system approvals 
which it has  ⌦ issued or ⌫ withdrawn and ⌦ shall ⌫ Ö , periodically or  , on 
⌦ upon ⌫ request, those it has issued  Ö make available to its notifying authorities the list 
of quality system approvals refused, suspended or otherwise restricted  . 
Each notified body must  ⌦ shall ⌫ also communicate to  ⌦ inform ⌫ the other notified 
bodies the relevant information concerning the  ⌦ of ⌫ quality system approvals 
⌦ which ⌫ it has ⌦ refused, suspended or ⌫ withdrawn Ö , and, upon request, of quality 
system approvals which it has issued  or refused . 
 
Ø new 
8. Authorised representative 
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.  
 
Ð 97/23/EC (adapted) 
8. MODULE E1:  (PRODUCT  QUALITY ASSURANCE ) ⌦ QUALITY ASSURANCE OF 
FINAL  PRESSURE EQUIPMENT  INSPECTION AND TESTING  ⌫ 
 
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1. This module describes the procedure wher eby the manufacturer who satisfies the 
obligations of secti on 3 ensures and declares that the pressure equipment satisfies the 
requirements of the Directive which apply to  it. The manufacturer , or his authorized 
representative established within the Communit y, must affix the CE marking to each item of 
pressure equ ipment and draw up a written  declaration of conformity. The CE marking must 
be accompanied by the identification number of the notified body responsible for surveillance 
as specified in section 5.  
 
Ø new 
1. Quality assurance of final pressure equipm ent 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. 
 
Ð 97/23/EC (adapted) 
Ö new 
2. The manufacturer must draw up the  tTechnical documentation described below.  
⌦ The manufacturer shall establ ish the technical documentation. ⌫ The technical 
documentation must enable  ⌦ shall make it possible to ⌫ an assessment  to be made of  the 
conformity of the pressure equipment with the ⌦ relevant ⌫ requirements Ö , and shall EN 134   EN include an adequate analysis and assessment of the risk(s)  of the Directive which apply to 
it. It must  ⌦ The technical documentation shall specify the applicable requirements and 
cover ⌫ , as far as is  relevant for such  ⌦ the ⌫ assessment, cover  the design, manufacture 
and operation of the pressure equipment.  and ⌦ The technical documentation shall, wherever 
applicable, ⌫ contain ⌦ at least the following elements ⌫ : 
– a general description of the pressure equipment , ; 
– conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ of 
components, sub-assemblies, circuits, etc., ; 
– descriptions and explan ations necessary for an  ⌦ the ⌫ understanding of the  
⌦ those ⌫ said  drawings and diagrams  ⌦ schemes ⌫ and the operation of the 
pressure equipment, ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5 , ⌦ the references 
of which have been published in the Official Journal of the European Union  ⌫, 
applied in full or in part, and descripti ons of the solutions adopted to meet the 
essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ Directive where the  ⌦ those 
harmonised ⌫ standards referred to in Article 5  have not been applied, . Ö In the 
event of partly applied harmonised sta ndards, the technical documentation shall 
specify the parts which have been applied;  
– results of design calculations made , examinations carried out, etc., ⌦ and ⌫ 
– test reports. 
 
Ø new 
3. The manufacturer shall keep the technica l documentation at th e disposal of the 
relevant national authorities for 10 years after the pressure equipment has been placed on the 
market. 
 
Ð 97/23/EC (adapted) 
Ö new 
34. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ operate an approved quality sy stem for the final pressure 
equipment  ⌦ product ⌫ inspection and testing ⌦ of the pressure equipment ⌫ as 
specified in section  point  45 and ⌦ shall ⌫ be subject to surveillance as specified in section  
point  56. 
45. Quality system 
45.1. The manufacturer must  ⌦ shall ⌫ lodge an application for assessment of his quality 
system with a  ⌦ the ⌫ notified body of his choice ⌦ , for the pressure equipment 
concerned ⌫ . 
The application must  ⌦ shall ⌫ include: EN 135   EN  
Ø new 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body; 
 
Ð 97/23/EC (adapted) 
Ö new 
– all relevant information on the pressure equipment ⌦ type envisaged ⌫ concerned  
,; 
– the documentation concerning the quality system. , ⌦ and ⌫ 
– Ö the technical documentation referred to in point 2.  
45.2. Ö The quality system shall ensure compliance of the pressure equipment with the 
requirements of this Directive that apply to it.  
Under the quality system, each item of pressure equipment must  ⌦ shall ⌫ be examined 
and appropriate tests as set out in the relevant standard(s) referred to in Article 5 12, or 
equivalent tests, and particularly final assessment as referred to in section  point  3.2 of Annex 
I, must  ⌦ shall ⌫ be carried out in order to ensure it s conformity with the requirements of 
the ⌦ this ⌫ Directive which apply to it.  
All the elements, requirements and pr ovisions adopted by the manufacturer must  ⌦ shall ⌫ 
be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must
 ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It must  ⌦ shall, in particular, ⌫ contain in particular  an adequate description of: 
 
Ð 97/23/EC 
– the quality objectives  and the organiz sational structure, res ponsibilities and powers 
of the management with regard to th e quality of the pressure equipment , ; 
– the procedures used for the permanent joining of parts as approved in accordance 
with section  point  3.1.2 of Annex I, ; 
 
Ð 97/23/EC (adapted) 
– the examinations and tests to  ⌦ that will ⌫ be carried out after manufacture, ; 
 
Ð 97/23/EC 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the qualifications or approvals of the personnel concerned, particularly EN 136   EN those of the personnel undertaking the perman ent joining of parts in accordance with 
section  point  3.1.2 of Annex I. ; 
– the means of monitoring the effectiv e operation of the quality system, . 
 
Ð 97/23/EC (adapted) 
Ö new 
45.3. The notified body must  ⌦ shall ⌫ assess the quality system to determine whether it 
satisfies the requirements referred to in 4 5.2.  
Ö It shall presume conformity with those requirements in respect of  Tthe elements of the 
quality system which conform to  the relevant harmonized stan dard are presumed to  
⌦ that ⌫ comply with the correspondi ng requirements referred to in  4.2 ⌦ specifications 
of the national standard that implements the relevant harmonised sta ndard and/or technical 
specification ⌫ . 
⌦ In addition to experience in quality management systems, ⌫ Tthe auditing team must  
⌦ shall ⌫ have at least one member with experience of assessing  ⌦ evaluation in the 
relevant ⌫ the  pressure equipment ⌦ field and pressure equipment ⌫ technology 
concerned Ö , and knowledge of the applicable requirements of this Directive  . The 
assessment procedure  must ⌦ audit shall ⌫ include an inspection  ⌦ assessment ⌫ visit to 
the manufacturer's premises. 
 
Ø new 
The auditing team shall review the technical docu mentation referred to in  point 2 in order to 
verify the manufacturer's ability to identify the re levant requirements of this Directive and to 
carry out the necessary examinations with a view to ensuring compliance of the pressure 
equipment with those requirements. 
 
Ð 97/23/EC (adapted) 
Ö new 
The decision must  ⌦ shall ⌫ be notified to the manufact urer. The notification must  
⌦ shall ⌫ contain the conclusions of the examination  ⌦ audit ⌫ and the reasoned 
assessment decision. Provision must be  made for an appeals procedure.   
45.4. The manufacturer must  ⌦ shall ⌫ undertake to discharge  ⌦ fulfil ⌫ the obligations 
arising from  ⌦ out of ⌫ the quality system as approved and to ensure  ⌦ maintain it so ⌫ 
that it remains satisfactory  ⌦ adequate ⌫ and efficient. 
5.5. The manufacturer, or his authorized repres entative established within the Community,  
must inform  ⌦ shall keep ⌫ the notified body which  ⌦ that ⌫ has approved the quality 
system ⌦ informed ⌫ of any intended adjustme nt ⌦ change ⌫ to the quality system. 
The notified body must assess the  ⌦ shall evaluate any ⌫ proposed changes and decide 
whether the modified quality system will still  ⌦ continue to ⌫ satisfy the requirements 
referred to in point  45.2 or whether a reassessment is required. EN 137   EN It must  ⌦ shall ⌫ notify ⌦ the manufacturer of ⌫ its decision to the manufacturer . The 
notification must  ⌦ shall ⌫ contain the conclusions of the examination and the reasoned 
assessment decision. 
 
Ð 97/23/EC 
56. Surveillance under the responsibil ity of the notified body 
56.1. The purpose of surveillance is to make su re that the manufactur er duly fulfils the 
obligations arising out of th e approved quality system. 
 
Ð 97/23/EC (adapted) 
56.2. The manufacturer must  ⌦ shall, for assessment purposes, ⌫ allow the notified body 
access for inspection purposes  to the locations of  ⌦ manufacture, ⌫ inspection, testing and 
storage ⌦ sites ⌫ and ⌦ shall ⌫ provide it with all necessary information, in particular: 
– 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 concerning the qualifications of  ⌦ on ⌫ the personnel 
concerned, etc. 
56.3. The notified body must  ⌦ 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  ⌦ shall ⌫ be such that a full 
reassessment is carried out every three years. 
56.4. In addition the notified body may pay unexpect ed visits to the manufacturer. The need 
for such additional visits, and the frequency ther eof, will be determined on the basis of a visit 
control system operated by the notified body. In particular, the following factors must  
⌦ shall ⌫ be considered in the visit control system: 
 
Ð 97/23/EC 
– 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 organiz sation, policy or techniques. 
 
Ð 97/23/EC (adapted) 
During such visits the notified body may, if necessary, carry out or have carried out  
⌦ product ⌫ tests,  ⌦ or have them carried out, in order ⌫ to verify that the quality EN 138   EN system is functioning corre ctly. The notified body must  ⌦ shall ⌫ provide the manufacturer 
with a visit report and, if a test has taken place  ⌦ tests have been carried out ⌫ , with a test 
report. 
 
Ø new 
7. CE marking and EU decl aration of conformity 
7.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in po int 5.1, the latter's identifica tion number to each individual 
pressure equipment that satisfies the app licable requirements of this Directive. 
7.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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 equipmen t model for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
 
Ð 97/23/EC (adapted) 
Ö new 
68. The manufacturer must  ⌦ shall ⌫, for a period of  ⌦ ending ⌫ ten 10 years after the 
last of the  pressure equipment has been manufactured  Ö placed on the market  , keep at the 
disposal of the national authorities: 
– the technical documentati on referred to in section 2,  
– the documentation referred to in the second indent of  point  45.1,; 
– the adjustments  ⌦ change ⌫ referred to in the second paragraph of  point  4.4 5.5, 
⌦ as approved; ⌫ 
– the decisions and reports from  ⌦ of ⌫ the notified body which are  referred to in 
the last paragraph of  45.3, the last paragraph of  4.45.5, and in  56.3 and 5 6.4. 
79. Each notified body must communicate  ⌦ shall inform ⌫ to the Member States the 
relevant information concerning the  Ö its notifying authorities of  quality system approvals 
which it has  ⌦ issued or ⌫ withdrawn and ⌦ shall ⌫ Ö periodically or  , on 
⌦ upon ⌫ request, those is has issued  Ö make available to its notif ying authorities the list 
of quality system approvals refused, suspended or otherwise restricted  . 
Each notified body must also communicate  ⌦ shall inform ⌫ the other notified bodies the 
relevant information concerning the  ⌦ of ⌫ quality system approvals ⌦ which ⌫ it has 
⌦ refused, suspended or ⌫ withdrawn Ö , and, upon request, of quality system approvals 
which it has issued  or refused . 
 
Ø new 
10. Authorised representative EN 139   EN 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. 
 
Ð 97/23/EC (adapted) 
Ö new 
9. MODULE F: ( ⌦ CONFORMITY TO TYPE BASED ON  ⌫ PRODUCT  ⌦ PRESSURE 
EQUIPMENT  ⌫ VERIFICATION ) 
1. This module describes the  ⌦ Conformity to type based on pressure equipment verification 
is the part of a conformity assessment ⌫ procedure whereby a  ⌦ the ⌫ manufacturer, or 
his authorized representative established within the Community,  Ö 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 section  
point  3, is in conformity with the type described:  in the EC type- ⌦ EU-type ⌫ examination 
certificate, or  
– in the EC design -examination certificate  
and satisfies the requirements of the  ⌦ this ⌫ Directive which apply to it. 
2. ⌦ Manufacturing ⌫ 
The manufacturer must  ⌦ shall ⌫ take all measures necessary to ensure  ⌦ so ⌫ that the 
manufacturing process Ö and its monitoring ensure conform ity of the manufactured products 
 requires the pressure equipment to comply  with the ⌦ approved ⌫ type described in the 
EC type - ⌦ EU-type ⌫ examination certificate, or  
– in the EC design -examination certificate  
and with the requirements of the  ⌦ this ⌫ Directive which apply to it  ⌦ them ⌫ . 
The manufacturer, or his authorized representative established within the Com munity, must 
affix the CE marking to all pr essure equipment and draw up a declaration of conformity.  
3. ⌦ Verification ⌫ 
The ⌦ A ⌫ notified body ⌦ chosen by the manufacturer ⌫ must perform  ⌦ shall carry 
out ⌫ the appropriate examinations and tests in or der to check the conformity of the pressure 
equipment with the relevant  Ö approved type described in the EU-type examination 
certificate and with the appropriate  requirements of the  ⌦ this ⌫ Directive by examining 
and testing every product in accordance with section 4 . 
 
Ð 97/23/EC 
The manufacturer, or his authorized representativ e established within the Community, must 
keep a copy of the declaration of conformity for a period of ten years af ter the last of the 
pressure equipment has been manufactured.  EN 140   EN  
Ø new 
The examinations and tests to check the conf ormity of the pressure equipment with the 
appropriate requirements shall be  carried out by exam ination and testing of every product as 
specified in point 4. 
 
Ð 97/23/EC (adapted) 
Ö new 
4. Verification ⌦ of conformity ⌫ by examination and testing of each item of  ⌦ every ⌫ 
pressure equipment  
4.1. Each item of  ⌦ All ⌫ pressure equipment must  ⌦ shall ⌫ be individually examined 
and must u ndergo  appropriate examinations and  tests as  set out in the relevant 
⌦ harmonised ⌫ standard(s) referred to in Article 5  or equivalent examinations and  tests 
⌦ shall be carried out ⌫ in order to verify  that it conforms to  the ⌦ conformity with the 
approved ⌫ type and Ö described in the EU-type examination certificate and with the 
appropriate  the requirements of the  ⌦ this ⌫ Directive which apply to it . Ö In the 
absence of such a harmonised standard, the notified body concerned shall decide on the 
appropriate tests to be carried out.  
In particular, the notified body must  ⌦ shall ⌫: 
 
Ð 97/23/EC 
– verify that the personnel undertaking the permanent joining of parts and the non-
destructive tests are qualified or ap proved in accordance with sections  points  3.1.2 
and 3.1.3 of Annex I, ; 
– verify the certificate issued by the materi als manufacturer in accordance with section  
point  4.3 of Annex I, ; 
– carry out or have carried out the final inspection and proof test referred to in section  
point  3.2 of Annex I and examine the safety devices, if applicable. 
 
Ð 97/23/EC (adapted) 
Ö new 
4.2. The notified body must  ⌦ shall ⌫ Ö issue a certificate of conformity in respect of the 
examinations and tests carried out, and  ⌦ shall ⌫ affix its identification number or have 
it affixed Ö under its responsibility  to each item of  ⌦ approved ⌫ pressure equipment 
and draw up a written certif icate of conformity relati ng to the tests carried out . 
 
Ø new 
The manufacturer shall keep th e certificates of conformity available for inspection by the 
national authorities for 10 years after the pressure equipment has been placed on the market. EN 141   EN  
Ð 97/23/EC 
4.3. The manufacturer, or his auth orized representative estab lished within the Community, 
must ensure that the certificates of confor mity issued by the notified body can be made 
available on request.  
 
Ø new 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 3, the latter 's identification number to each individual 
pressure equipment that is in conformity with  the approved type de scribed in the EU-type 
examination certificate and satisfies the appl icable requirements of this Directive. 
5.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the disp osal 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 equipmen t model for which it has been drawn up. 
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 agre es and under its responsib ility, 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, th e manufacturer may affix the 
notified body's identification number to the pr essure equipment during the manufacturing 
process. 
7. Authorised representative 
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 points 2.  
 
Ð 97/23/EC (adapted) 
10. MODULE G:  
( ⌦ CONFORMITY BASED ON ⌫ EC UNIT VERIFICATION ) 
 
Ð 97/23/EC  
1. This module describes the procedure whereby the manufacturer ensures and declares that 
pressure equipment which ha s been issued with the  certificate referred to in section 4.1 
satisfies the requirements of the Directive whic h apply to it. The manufacturer must affix the 
CE marking to the pressure equipment a nd draw up a declaration of conformity.  EN 142   EN  
Ø new 
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 respons ibility that the pressure equi pment concerned, which has been 
subject to the provisions of point  4, is in conformity with the requirements of this Directive 
that apply to it. 
 
Ð 97/23/EC 
2. The manufacturer must apply to a notif ied body of his choice for unit verification.  
The application must contain:  
– the name an d address of the manufacturer and the location of the pressure equipment,  
– a written declaration to the e ffect that a similar applica tion has not been lodged with 
another notified body,  
– technical documentation.  
 
Ð 97/23/EC (adapted) 
32. ⌦ Technical documentation ⌫ 
 
Ø new 
The manufacturer shall establish the technica l documentation and make it available to the 
notified body referred to in point 4. 
 
Ð 97/23/EC (adapted) 
Ö new 
The technical  documentation must enable  ⌦ shall make it possible to assess ⌫ the 
conformity of the pressure equipment with the ⌦ relevant ⌫ requirements of the Directive 
which apply to it to be  assesse d and Ö shall include an adequate analysis and assessment of 
the risk(s). The technical documentation shall sp ecify the applicable requirements and cover, 
as far as relevant for the assessment,  the design, manufacture and operation of the pressure 
equipment to be understood . 
The technical documentation must  ⌦ shall, wherever applicable, ⌫ contain ⌦ at least the 
following elements ⌫ : 
 
Ð 97/23/EC 
– a general description of the pressure equipment, ; EN 143   EN  
Ð 97/23/EC (adapted) 
Ö new 
– conceptual design and manufact uring drawings and diagrams  ⌦ schemes ⌫ of 
components, sub-assemblies, circuits, etc., ; 
– descriptions and explanations necessary for an understanding of the  ⌦ those ⌫ 
said drawings and diagrams  ⌦ schemes ⌫ and the operation of the pressure 
equipment, ; 
– a list of the ⌦ harmonised ⌫ standards referred to in Article 5  ⌦ the references of 
which have been published in the Official Journal of the European Union  ⌫, 
applied in full or in part, and descripti ons of the solutions adopted to meet the 
essential ⌦ safety ⌫ requirements of the  ⌦ this ⌫ Directive where the  ⌦ those 
harmonised ⌫ standards,  referred to in Article 5  have not been applied, . Ö In the 
event of partly applied harmonised sta ndards, the technical documentation shall 
specify the parts which have been applied;  
– results of design calculations made , examinations carried out, etc., ; 
 
Ð 97/23/EC 
– test reports, ; 
– appropriate details relating to the approval of the manufacturing and test procedures 
and of the qualifications or approvals of the personnel conc erned in accordance with 
sections  points  3.1.2 and 3.1.3 of Annex I. 
 
Ø new 
The manufacturer shall keep th e technical documentation at th e disposal of the relevant 
national authorities for 10 years after the pressure equipment has been placed on the market. 
3. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactured pressure e quipment with the applicable 
requirements of this Directive. 
 
Ð 97/23/EC (adapted) 
Ö new 
4. ⌦ Verification ⌫ 
The ⌦ A ⌫ notified body ⌦ chosen by the manufacturer ⌫ must  ⌦ shall carry out 
appropriate examinations ⌫ examine the design and construction of each item of pressure 
equipment and during manufacture perfor m appropriate  ⌦ and ⌫ tests,  as set out in the 
relevant ⌦ harmonised ⌫ standard(s) referred to in Articl e 5 of the Directive,  and/or 
equivalent examinations and  tests, to ensure its  ⌦ check the ⌫ conformity ⌦ of the 
pressure equipment ⌫ with the ⌦ applicable ⌫ requirements of the  ⌦ this ⌫ Directive EN 144   EN which apply to it ., Ö or have them carried out. In the ab sence of such a harmonised standard 
the notified body concerned shall decide on the a ppropriate tests to be carried out applying 
other technical specifications.  
In particular the notified body must  ⌦ shall ⌫: 
 
Ð 97/23/EC  
– 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 a pproval for pressure equipment materials, 
and check the certificate issued by the material manufacturer in accordance with 
section  point  4.3 of Annex I, ; 
– approve the procedures for the permanent jo ining of parts or check that they have 
been previously approved in accordance with section  point  3.1.2 of Annex I, ; 
– verify the qualifications or approvals required under sections  points  3.1.2 and 3.1.3 
of Annex I, ; 
– carry out the final inspection referred to in section  point  3.2.1 of Annex I, perform or 
have performed the proof te st referred to in section  point  3.2.2 of Annex I, and 
examine the safety devices, if applicable. 
 
Ð 97/23/EC (adapted) 
Ö new 
4.1. The notified body must  ⌦ shall ⌫ Ö 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 to the pressure equipment and draw 
up a certificate of conform ity for the tests carried out  ⌦ under its responsibility ⌫ . This  
⌦ The ⌫ certificate must be kept for a period of  Ö manufacturer shall keep the certificates 
of conformity at the disposal of the national authorities for  ten 10 years Ö after the 
pressure equipment has been placed on the market  . 
 
Ð 97/23/EC 
4.2. The manufacturer, or his auth orized representative estab lished within the Community, 
must ensure that the declaration of conform ity and certificate of conformity issued by the 
notified body can be made available on request.  
 
Ø new 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 4, the latter 's identification numbe r to each pressure 
equipment that satisfies the applicable requirements of this Directive. EN 145   EN 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 conf ormity shall identify the pressure equipment 
for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request. 
6. Authorised representative 
The manufacturer's obligations set out in points 2 and 5 may be  fulfilled by his authorised 
representative, on his behalf and under his respons ibility, provided that th ey are specified in 
the mandate. 
 
Ð 97/23/EC (adapted) 
11. MODULE H: ( ⌦ CONFORMITY BASED ON  ⌫ FULL QUALITY ASSURANCE ) 
 
Ð 97/23/EC 
1. This module describes the procedure wher eby the manufacturer who satisfies the 
obligations of section 2 ensures and declares th at the pressure equipment in question satisfies 
the requir ements of the Directive which apply to it. The manufacturer, or his authorized 
representative established within the Communit y, must affix the CE marking to each item of 
pressure equipment and draw up a written decl aration of conformity. The CE marking mus t 
be accompanied by the identification number of the notified body responsible for surveillance 
as specified in section 4.  
 
Ø new 
1. Conformity based on full quality assuran ce 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 responsib ility that the pressure equi pment concerned satisfies the 
requirements of this Directive that apply to it. 
 
Ð 97/23/EC (adapted) 
2. ⌦ Manufacturing ⌫ 
The manufacturer must implement  ⌦ shall operate ⌫ an approved quality system for 
design, manufacture, final ⌦ product ⌫ inspection and testing ⌦ of the pressure 
equipment ⌫ as specified in section  point  3 and ⌦ shall ⌫ be subject to surveillance as 
specified in section  point  4. 
3. Quality system 
3.1. The manufacturer must  ⌦ shall ⌫ lodge an application for assessment of his quality 
system with a  ⌦ the ⌫ notified body of his choice,  ⌦ for the pressure equipment 
concerned ⌫. EN 146   EN The application must  ⌦ shall ⌫ include: 
 
Ð 97/23/EC 
– all relevant information concerning the pressure equipment in question,  
 
Ø new 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; 
– the technical documentation for one model of each type of pressure equipment 
intended to be manufactured. The tec hnical documentation shall, wherever 
applicable, contain at least the following elements: 
– a general description of the pressure equipment; 
– conceptual design and manufacturing dr awings and schemes of components, 
sub-assemblies, circuits, etc.; 
– descriptions and explanations nece ssary for the understanding of those 
drawings and schemes and the opera tion of the pressure equipment; 
– a list of the harmonised st andards 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 harmonise d 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; 
 
Ð 97/23/EC (adapted) 
– the documentation concerning the quality system. , ⌦ and ⌫ 
 
Ø new 
– a written declaration that the same applic ation has not been lodged with any other 
notified body. 
 
Ð 97/23/EC (adapted) 
3.2. The quality system must  ⌦ shall ⌫ ensure compliance of the pressure equipment with 
the requirements of the  ⌦ this ⌫ Directive which  ⌦ that ⌫ apply to it. 
All the elements, requirements and pr ovisions adopted by the manufacturer must  ⌦ shall ⌫ 
be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This
 ⌦ That ⌫ quality system documentation must  ⌦ shall ⌫ permit a EN 147   EN consistent interpretation of the procedural and  quality measures such as  programmes, plans, 
manuals and records. 
It must  ⌦ shall ⌫ contain  , in particular,  ⌦ contain ⌫ an adequate description of: 
– the quality objectives  and the organiz sational structure, res ponsibilities and powers 
of the management with rega rd to the quality of the  design and to  product quality, ; 
– the technical design specifications, includi ng standards, that will be applied and, 
where the ⌦ relevant harmonised ⌫ standards referred to in Article 5 are  
⌦ will ⌫ not ⌦ be ⌫ applied in full, the means that  will be used to ensure that 
the essential requirements of the  ⌦ this ⌫ Directive which  ⌦ that ⌫ apply to the 
pressure equipment will be met, ; 
 
Ð 97/23/EC (adapted) 
Ö new 
– the design control and desi gn verification techniques, processes and systematic 
measures  ⌦ actions ⌫ that will be used when de signing the pressure equipment, 
Ö pertaining to the product type covered,  particularly with regard to materials in 
accordance with section  point  4 of Annex I, ; 
– the corresponding manufacturi ng, quality control and qua lity assurance techniques, 
processes and systematic measures  ⌦ actions ⌫ that will be use d, particularly the 
procedures for the permanent joining of part s as approved in accordance with section  
point  3.1.2 of Annex I, ; 
 
Ð 97/23/EC 
– the examinations and tests to be carried out before, during, a nd after manufacture, 
and the frequency with which they will be carried out, ; 
 
Ð 97/23/EC (adapted) 
Ö new 
– the quality records, such as inspection repor ts and test data, ca libration data, reports 
concerning the qualifications or approvals of the personnel concerned, particularly 
those of the personnel unde rtaking the perman ent joining of parts and the non-
destructive tests in accordance with sections  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 design and  quality and the effective oper ation of the quality system. 
3.3. The notified body must  ⌦ shall ⌫ assess the quality system to determine whether it 
satisfies the requirements referred to in point  3.2. The elements of the quality system which 
conform to the relevant harmonized standard are presumed to comply with the corresponding 
requirements r eferred to in 3.2.  Ö It shall presume conformity  with those requirements in 
respect of the elements of  the quality system that comply with the corresponding 
specifications of the national standard that implements the relevant harmonised standard 
and/or technical specification.  EN 148   EN ⌦ In addition to experience in quality management systems, ⌫ Tthe auditing team must  
⌦ shall ⌫ have at least one member with experience of  ⌦ experienced as assessor ⌫ 
assessing  ⌦ in ⌫ the pressure equipm ent technology concerned Ö , and knowledge of the 
applicable requirements of this Directive  . The assessment proced ure must  ⌦ audit 
shall ⌫ include an inspection  ⌦ assessment ⌫ visit to the manufacturer's premises. 
 
Ø new 
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 examin ations with a view to  ensuring compliance of 
the pressure equipment with those requirements. 
 
Ð 97/23/EC (adapted) 
The ⌦ manufacturer or his authorised representative ⌫ decision  must  ⌦ shall ⌫ be 
notified ⌦ of the decision ⌫ to the manufacturer . The notification must  ⌦ shall ⌫ contain 
the conclusions of the examination  ⌦ audit ⌫ and the reasoned assessment decision. 
Provision must  be made for an appeals procedure.  
3.4. The manufacturer must  ⌦ shall ⌫ undertake to fulfil the oblig ations arising out of the 
quality system as approved and to ensure  ⌦ maintain it so ⌫ that it remains satisfactory  
⌦ adequate ⌫ and efficient. 
The manufacturer, or his authorized representative establ ished within the Community,  must  
inform  ⌦ shall keep ⌫ the notified body that has approved the quality system 
⌦ informed ⌫ of any intended adjustment  ⌦ change ⌫ to the quality system. 
The notified body must assess  ⌦ shall evaluate ⌫ the ⌦ any ⌫ proposed changes and 
decide whether the modified  quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in 3.2 or whether a reassessment is required  ⌦ necessary ⌫ . 
It must  ⌦ shall ⌫ notify its decision to  the manufacturer ⌦ of its decision ⌫ . The 
notification must  ⌦ shall ⌫ contain the conclusions of the examination and the reasoned 
assessment decision. 
4. Surveillance under the responsibility of the notified body 
4.1. The purpose of this  surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
4.2. The manufacturer must  ⌦ shall, for assessment purposes, ⌫ allow the notified body 
access for inspection purposes  to the locations of  design, manufacture, inspection, testing and 
storage ⌦ sites ⌫ and ⌦ shall ⌫ provide it with all necessary information, in particular: 
– the quality system documentation, ; 
– the quality records provided for in  ⌦ by ⌫ the design part of the quality system, 
such as results of analyses, calculations, tests, etc., ; EN 149   EN – the quality records provided for in  ⌦ by ⌫ the manufacturing part of the quality 
system, such as inspection reports and test data, calibration data, ⌦ qualification ⌫ 
reports concerning the qualifications of  ⌦ on ⌫ the personnel concerned, etc. 
4.3. The notified body must  ⌦ shall ⌫ carry out periodic audits to make sure that the 
manufacturer maintains and applies the quality system and ⌦ shall ⌫ provide the 
manufacturer with an au dit report. The frequency of periodic audits must  ⌦ shall ⌫ be such 
that a full reassessment is carried out every three years. 
4.4. In addition,  the notified body may pay unexpected visits to the manufacturer.  
The need for such additional visi ts, and the frequency thereof, will be determined on the basis 
of a visit control system operated by the no tified body. In particular, the following factors 
must  ⌦ shall ⌫ be considered in the visit control system: 
 
Ð 97/23/EC 
– 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 organiz sation, policy or techniques. 
 
Ð 97/23/EC (adapted) 
Ö new 
During such visits,  the notified body may, if necessary, carry out or have carried out  
⌦ product ⌫ tests ⌦ , or have them carried out, in order ⌫ to verify that the quality 
system is  ⌦ check the proper ⌫ functioning correctly  ⌦ of the quality system ⌫ . The 
notified body  ⌦ It ⌫ must  ⌦ shall ⌫ provide the manufacturer with  a visit report and, if a 
test has taken place  ⌦ tests have been carried out ⌫ , with a test report. 
 
Ø new 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 3.1, the latt er's identification number to each individual 
pressure equipment that satisfies the app licable requirements of this Directive. 
5.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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 equipmen t model for which it has been drawn up. 
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request. EN 150   EN  
Ð 97/23/EC (adapted) 
Ö new 
56. The manufacturer must  ⌦ shall ⌫, for a period of  ⌦ ending ⌫ ten 10 years after the 
last of the  pressure equipment has been manufactured  Ö placed on the market  , keep at the 
disposal of the national authorities: 
– the ⌦ technical ⌫ documentation referred to in the second indent of the second 
subparagraph of  point  3.1; 
– Ö the documentation concerning the quality  system referred to in point 3.1;  
– the adjustments  ⌦ change ⌫ referred to in the second subparagraph of  point  3.4, 
⌦ as approved ⌫ ; 
– the decisions and reports from  ⌦ of ⌫ the notified body which are  referred to in 
the last subparagraph of  point  3.3, the last subparagraph of  3.4, and in  4.3 and 4.4. 
67. Each notified body must comm unicate to the Member States  Ö shall inform its notifying 
authorities of  the relevant information concerning the  quality system approvals which it 
has ⌦ issued or ⌫ withdrawn, and Ö shall, periodically or  , on ⌦ upon ⌫ request, 
those it has issued  Ö make available to its notifying aut horities the list of quality system 
approvals refused, suspended or otherwise restricted  . 
Each notified body must also communicate to  ⌦ shall inform ⌫ the other notified bodies 
the relevant information concerning the  ⌦ of ⌫ quality system approvals ⌦ which ⌫ it 
has ⌦ refused, suspended or ⌫ withdrawn,  or refused  Ö and, upon request, of quality 
system approvals which it has issued  . 
 
Ø new 
8. Authorised representative 
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. 
 
Ð 97/23/EC (adapted) 
12. MODULE H1:  ( ⌦ CONFORMITY BASED ON  ⌫ FULL QUALITY ASSURANCE WITH  
⌦ PLUS  ⌫ DESIGN EXAMINATION AND SPECIAL SURVEILL ANCE OF THE FINAL 
ASSESSMENT ) 
 
Ð 97/23/EC 
1. In addition to the requirements of module H, the following apply:  
(a) the manufacturer must lodge an application for examinat ion of the design with the 
notified body;  EN 151   EN (b) the application must enable the design, ma nufacture and operation of the pressure 
equipment to be understood, and enable conform ity with the relevant requirements of the 
Directive to be assessed.  
 It must inclu de: 
– the technical design specifications, incl uding standards, which have been 
applied,  
– the necessary supporting evidence for thei r adequacy, in particular where the 
standards referred to in Artic le 5 have not been applie d in full. This supporting 
evidence must include the results of test s carried out by the appropriate 
laboratory of the manufact urer or on his behalf;  
(c) the notified body must examine the applic ation and where the design meets the 
provisions of the Directive whic h apply to it issue an EC de sign-examination certificate to the 
applicant. The certificate must  contain the conclusions of th e examination, the conditions for 
its validity, the necessary data for identification of the approve d design and, if relevant, a 
description of the functioning  of the pressure equipment or accessories;  
(d) the applicant must inform the notifie d body that has issued the EC design -examination 
certificate of all modifications to the approved design. Modifica tions to the approved design 
must receive additional appro val from the notified body th at issued the EC design -
examination certificate where they may affect c onformity with the essential requirements of 
the Directive or the prescribed conditions for us e of the pressure equipment. This additional 
approval must be given in the form of an add ition to the original EC design -examination 
certificate;  
(e) each notified body must also communicate to the other notified bodies the relevant 
information concerning the EC design -examination certificates it has withdrawn or ref used.  
2. 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 must conduct examinations on the pressure equipme nt. 
 
Ø new 
1. Conformity based on full quality assuranc e 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 equi pment concerned satisfy the requirements of the 
Directive that apply to it. 
2. Manufacturing 
The manufacturer shall operate an approved qua lity system for design, manufacture and final 
product inspection and testing of the products concerned as specifi ed 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 EN 152   EN 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. 
The application shall include: 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well; 
– the technical documentation for one model of each type of pressure equipment 
intended to be manufactured. The tec hnical documentation shall, wherever 
applicable, contain at least the following elements: 
– a general description of the pressure equipment; 
– conceptual design and manufactur ing drawings and schemes of 
components, sub-assemb lies, circuits, etc., 
– descriptions and explanations neces sary for the understanding of those 
drawings and schemes and the opera tion of the pressure equipment;  
– a list of the harmonised standards th e references of which have been 
published in the Official Journal of the European Union , applied in full 
or in part, and descriptions of the so lutions adopted to meet the essential 
safety requirements of this Direc tive where those harmonised standards 
have not been applied. In the ev ent 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 applic ation 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. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures 
and instructions. This quality system documenta tion shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of: 
– the quality objectives and the organisational structure, responsibi lities and powers of 
the management with regard to design and product quality; 
– the technical design specifications, includi ng standards, that will be applied and, 
where relevant harmonised standards will not be applied in full, the means that will EN 153   EN 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 desi gn 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 manufacturi ng, quality control and qua lity 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 repor ts and test data, ca libration data, reports 
concerning the qualifications or approvals of the personnel concerned, particularly 
those of the personnel undert aking the permanen t joining of pa rts 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 syst em to determine whether it satisfies the 
requirements referred to in point 3.2. 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised standard and/or technical specifications. 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 equipmen t field and pressure equipment 
technology concerned, and knowledge of the appli cable 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 examin ations with a view to  ensuring compliance of 
the pressure equipment with those requirements. 
The manufacturer or his aut horised representative shall be notified of the decision. 
The notification shall contain the conclusion s of the audit and the reasoned assessment 
decision. 
3.4. The manufacturer shall undertake to fulfil the obligations arisi ng out of the quality 
system as approved and to maintain it so  that it remains adequate and efficient. 
3.5. The manufacturer shall keep  the notified body that has approved the quality system 
informed of any intended change to the quality system. EN 154   EN The notified body shall evaluate any proposed changes and decide whether the modified 
quality system will continue to satisfy the requ irements 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, suspe nded or otherwise restricted. 
Each notified body shall inform the other notifie d bodies of quality system approvals which it 
has refused, suspended or withdrawn, and, upon reque st, of quality system approvals which it 
has issued. 
4. Design examination 
4.1. The manufacturer shall lodge an applica tion 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. 
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: 
– the name and address of the manufacturer; 
– a written declaration that the same applic ation has not been lodged with any other 
notified body; 
– the technical documentation. The documentati on shall make it possible to assess the 
conformity of the pressure equipment w ith the relevant requirements, and shall 
include an adequate analysis and asse ssment of the risk(s). The technical 
documentation shall specify the applicable requ irements and cover, as far as relevant 
for the assessment, the design and operation of the pressure equi pment. The technical 
documentation shall, wherever applicable, contain at least the following elements: 
– a general description of the pressure equipment;  
– conceptual design and manufactur ing drawings and schemes of 
components, sub-assemblies, circuits, etc.; 
– descriptions and explanations neces sary for the understanding of those 
drawings and schemes and the opera tion of the pressure equipment;  
– a list of the harmonised standards th e references of which have been 
published in the Official Journal of the European Union , applied in full 
or in part, and descriptions of the so lutions adopted to meet the essential 
safety requirements of this Direct ive, where those harmonised standards 
have not been applied. In the ev ent of partly applied harmonised 
standards, the technical documentation shall specify the parts which have 
been applied; EN 155   EN – 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 doc uments 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 app lication, 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 cer tificate shall give the name and address of 
the manufacturer, the conclusions of the examina tion, the conditions (if any) for its validity 
and the data necessary for iden tification of the approved design. The certificate may have one 
or more annexes attached. 
The certificate and its a nnexes 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 appr ised 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 no tified body shall inform the manufacturer 
accordingly. 
The manufacturer shall keep th e 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 require ments of this Directive or th e conditions for validity of the 
certificate. Such modifications shall require a dditional 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 additi ons 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. 
Each notified body shall inform the other not ified bodies of the EU design examination 
certificates and/or any additi ons thereto which it has refu sed, withdrawn, suspended or 
otherwise restricted, and, upon re quest, of the certificates and/or  additions thereto which it has 
issued. 
The Commission, the Member States and the ot her notified bodies may, on request, obtain a 
copy of the EU design examination certificate s and/or additions thereto. On request, the EN 156   EN 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 de sign 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 th e 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. 
5. Surveillance under the res ponsibility of the notified body 
5.1. The purpose of surveillance is to make sure that the manufacturer duly  fulfils the 
obligations arising out of th e approved quality system. 
5.2. The manufacturer shall, for assessment pur poses, allow the notified body access to the 
design, manufacture, inspection, te sting and storage sites, a nd shall provide it with all 
necessary information, in particular: 
– the quality system documentation; 
– the quality records as provided for by the de sign part of the quali ty 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, ca libration data, qualific ation reports on the 
personnel concerned, etc. 
5.3. The notified body shall carry out periodic aud its 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. 
5.4. In addition, the notified body may pay unexp ected visits to the manufacturer.  
The need for such additional visi ts, and the frequency thereof, will be determined on the basis 
of a visit control system operated by the no tified 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 approv al of the system, where applicable; 
– significant changes in manufacturing organisation, policy or techniques. 
During such visits, the notified body may, if nece ssary, carry out product tests, or have them 
carried out, in order to check the proper functio ning of the quality system. It shall provide the 
manufacturer with a visit repor t and, if tests have been carri ed out, with a test report. EN 157   EN 5.5 Special surveillance of the final assessment 
Final assessment as referred to in section 3.2 of Annex I is subject to in creased surveillance in 
the form of unexpected visits by the notified bo dy. In the course of such visits, the notified 
body shall conduct examinations on the pressure equipment. 
It shall provide the manufacturer with a visit repo rt and, if tests have been carried out, with a 
test report. 
6. CE marking and EU decl aration of conformity 
6.1. The manufacturer shall affix the CE mark ing and, under the responsibility of the 
notified body referred to in point 3.1, the latt er's identification number to each individual 
pressure equipment that satisfies the app licable requirements of this Directive. 
6.2. The manufacturer shall draw up a written EU declaration of conformity for each 
pressure equipment model and keep it at the di sposal 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. 
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 endi ng 10 years after the pr essure equipment has 
been placed on the market, keep at th e disposal of the national authorities: 
– 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 notifie d body referred to in points 3.5, 5.3 and 5.4. 
8. Authorised representative 
The manufacturer's authorised representative ma y 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. 
 
Ð 97/23/EC 
ANNEX IV  
MINIMUM CRITERIA TO  BE MET WHEN D ESIGNATING THE NOTIFIED 
BODIES REFERRED TO IN ARTI CLE 12 AND THE RECOGNIZED THIRD -
PARTY ORGANIZATIONS REFERRED TO IN ARTICLE 13  
1. The body, its director and the personnel resp onsible for carrying out the assessment and 
verification operations may not be t he designer, manufacturer, supplie r, installer or user of the 
pressure equipment or assemblies which that body inspects, nor the authorized representative 
of any of those parties. They  may not become directly invol ved in the design, construction, 
marketing  or maintenance of the pressure equipmen t or assemblies, nor represent the parties EN 158   EN engaged in these activities. This  does not preclude the possibili ty of exchanges of technical 
information between the manufacturer of pressure equipment or assemblies and th e notified 
body.  
2. The body and its personnel must carry out the assessments and verifications with the 
highest degree of professional integrity and tech nical competence and must be free from all 
pressures and inducements, par ticularly financial, which mi ght influence their judgment or the 
results of the inspection, especially from persons  or groups of persons with an interest in the 
results of verifications.  
3. The body must have at its disposal the ne cessary personnel and possess the necessary 
facilities  to enable it to perform properly the technical and administrative tasks connected 
with the inspection and surveillance operations, it must also have access to the equipment 
required to perform special verifications.  
4. The personnel res ponsible for inspec tion must have:  
– sound technical and vocational training,  
– satisfactory knowledge of the requirements of the inspections they carry out and 
adequate experience of such operations,  
– the ability required to draw up the certi ficates, records and reports to demon strate 
that the inspections have been carried out.  
5. The impartiality of the inspection personnel must be guaranteed. Their remuneration must 
not depend on the number of inspections carried out, nor on the results of such inspections.  
6. The body must tak e out liability insurance unless its lia bility is assumed by the State in 
accordance with national law, or the Member State itself is directly responsible for the 
inspections.  
7. The personnel of the body must observe professional secrecy with regard to al l information 
gained in carrying out their tasks (except vis -à-vis the competent administrative authorities of 
the State in which their activi ties are carried out) under the Directive or any provision of 
national law giving effect to it.  
ANNEX V  
CRITERIA T O BE MET WHEN AUTHORIZING USER INSPECTORATES 
REFERRED TO IN ARTICLE 14  
1. The user inspectorate must be organizatio nally identifiable and have reporting methods 
within the group of which it is part which ensure and demonstr ate its impartiality. It must not  
be responsible for the design, manufacture, s upply, installation, operation or maintenance  of 
the pressure equipment or assemblies, and mu st not engage in any activities that might 
conflict with its independence of judg ment and integrity in relation to it s inspection activities.  
2. The user inspectorate and its personnel must  carry out the assessments and verifications 
with the highest degree of professional integrity  and technical competence and must be free 
from all pressures and inducements, particularl y financial, which might influence their EN 159   EN judgment or the results of the in spection, especially from persons or groups of persons with an 
interest in the results of verifications.  
3. The user inspectorate must have at its disposal the necessary personnel an d possess the 
necessary facilities to enable it to perform properly the tec hnical and administrative tasks 
connected with the inspection and surveillance operations; it must also have access to the 
equipment required to perform special verifications.  
4. Th e personnel responsible fo r inspection must have:  
– sound technical and vocational training,  
– satisfactory knowledge of the requirements of the inspections they carry out and 
adequate experience of such operations,  
– the ability required to draw up the certific ates, records and reports to demonstrate 
that the inspections have been carried out.  
5. The impartiality of inspection personnel must  be guaranteed. Their remuneration must not 
depend on the number of inspections carried  out, nor on the results of such ins pections.  
6. The user inspectorate must ha ve adequate liability insuran ce unless liability is assumed by 
the group of which it is part.  
7. The personnel of the user inspectorate must obs erve professional secrec y with regard to all 
information gained in car rying out their tasks (except vis -à-vis the competent administrative 
authorities of the State in wh ich their activities are carrie d out) under the Directive or any 
provision of national law giving effect to it.  EN 160   EN ANNEX VI  
CE MARKING  
The CE marking consists of the initials «CE» taking the following form:  
 
If the CE marking is reduced  or enlarged the proportions  given in the above graduated 
drawing must be respected.  
The various components of the CE marking mu st have substantially  the same vertical 
dimension, which may not be less than 5  mm. 
 
Ð 97/23/EC (adapted) 
ANNEX VIIIV 
⌦ EU ⌫ DECLARATION OF CONFORMITY 
The EC  ⌦ EU ⌫ declaration of conformity must  ⌦ shall ⌫ contain the following 
particulars : 
 
Ø new 
1. No … (unique identification of the pressure equipment): 
2. Pressure equipment/pressure equipment model (product, batch, type or serial number):  
 
Ð 97/23/EC (adapted) 
2.3 n Name and address of the manufacturer ⌦ and, where applicable, ⌫ or of  his 
authoriz sed representative established within the Community ,: EN 161   EN  
Ø new 
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.  
4. Object of the declaration (ide ntification of pressure equipmen t allowing traceability. It may, 
where necessary for the identification of the pressure equipment, include an image:  
 
Ð 97/23/EC (adapted) 
– description of the pressure equipment or assembly ,; 
 
Ð 97/23/EC (adapted) 
– conformity assessment procedure followed, ; 
– in the case of assemblies, description of  the pressure equipment constituting the 
assembly, and the conformity assessment procedures followed, ; 
– where appropriate, ⌦ the ⌫ name, and address ⌦ and number ⌫ of the 
notified body which carri ed out the inspection ⌦ and the number of the 
certificate issued ⌫ ,; 
 
Ð 97/23/EC (adapted) 
– where appropriate, a reference to the EC type- ⌦ EU-type ⌫ examination 
certificate, EC design - ⌦ EU-design ⌫ examination certificate or EC  
⌦ EU ⌫ certificate of conformity, . 
 
Ø new 
5. The object of the declaration described above is in conformity with the relevant Union 
harmonisation legislation: ……………. (reference to  the other Union Directives applied): 
6. References to the relevant harmonised standards used or references to the specifications in 
relation to which conformity is declared: 
 
Ð 97/23/EC 
– where appropriate, name and addre ss of the notified body monitoring the 
manufacturer's quality assurance system,  
 
Ø new 
8. Additional information: 
Signed for and on behalf of: ……………………. 
(place and date of issue): 
(name, function) (signature): EN 162   EN  
Ð 97/23/EC 
– where appropriate, the references of the harmonized standards applied,  
– where appropriate, other technical standards and specifications used,  
 
Ð 97/23/EC (adapted) 
– And⌦ where appropriate, ⌫ particulars of the signato ry authorized to sign the 
legally binding declaration for th e manufacturer or his authoriz sed representative 
established within the Community . 
– where appropriate, the references of the other Community Directives  applied.  
 
Ï 
ANNEX V  
PART  A 
Repealed Directive with its successive amendments  
(referred to in Article 50) 
Directive 97/23/EC of the Eu ropean Parliament and of 
the Council  (OJ L 181, 9.7.1997, p.1) 
Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) 
Regulation (EU) No 1025/2012 of the European 
Parliament and of the Council (OJ L 316, 14.11.2012, p. 12) 
 
PART  B 
Time-limits for transposition into national law and application  
(referred to in Article 15) 
Directive Time-limit for transposition Date of application 
97/23/EC 29 May 1999 29 November 199945 
 
                                                 
45 In accordance with Article 20(3) of Directive 97/ 23/EC, Member States shall permit 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 the Directive beyond that date. EN 163   EN ANNEX VI  
CORRELATION TABLE  
Directive 97/23/EC This Directive 
  
Article 1(1) Article 1(1) 
Article 1(2) Article 2 (1) to (14) 
___ Article 2 (15) to (31) 
Article 1(3) Article 1(2) 
Article 2 Article 3 
Article 3 Article 4 
Article 4 Article 5 
___ Article 6 
___ Article 7 
___ Article 8 
___ Article 9 
___ Article 10 
___ Article 11 
Article 5(1) Article 12(2) 
Article 5(2) ___ 
Article 5(3)  
___ Article 12(1) 
Article 7(1) Article 40 
Article 7(2) Article 39(1) 
___ Article 39(2) 
Article 7(3) Article 39(3) 
Article 7(4) Article 39(4) 
Article 8 ___ EN 164   EN Article 9(1) Article 13(1)  introductory sentence 
Article 9(2) point 1 ____ 
____ Article 13(1) (a) 
Article 9(2) point 2 Article 13(1) (b) 
Article 9(3) Article 13(2) 
Article 10 Article 14 
Article 11(1) Article 15(1) 
Article 11(2) Article 15(2) 
Article 11(3) Article 15(3) 
Article 11(4) Article 12(3) 
___ Article 15(4) 
Article 11(5) Article 15(5) 
___ Article 15(6) 
Article 12 ___ 
Article 13 ___ 
Article 14(1)  Article 16(1) 
Article 14(2) Article 5(3) 
Article 14(3) to (8) Article 16(2) to (7) 
Article 14(9) and (10) ___ 
___ Article 17 
___ Article 18 
Article 15(1) ___ 
Article 15(2) Article 19(1) 
Article 15(3) Article 19(2) 
Article 15(4) and (5) ___ 
___ Article 19(3) to (5) 
___ Article 20 EN 165   EN ___ Article 21 
___ Article 22 
___ Article 23 
___ Article 24 
___ Article 25 
___ Article 26 
___ Article 27 
___ Article 28 
___ Article 29 
___ Article 30 
___ Article 31 
___ Article 32 
___ Article 33 
___ Article 34 
___ Article 35 
___ Article 36 
___ Article 37 
___ Article 38 
Article 16 ___ 
Article 17 ___ 
Article 18 ___ 
___ Article 41 
___ Article 42 
Article 19 ___ 
Article 20 (1) to (2) ___ 
Article 20(3)  Article 43(1) 
___ Article 43(2) and (3) EN 166   EN ___ Article 44 
___ Article 45 
___ Article 46 
Article 21 Article 47 
Annex I Annex I 
Annex II Annex II 
Annex III, introductory wording Annex III, introductory wording 
Annex III, Module A Annex III, point 1, Module A 
Annex III, Module A1 Annex III, point 2, Module A2  
Annex III, Module B Annex III, point 3.1, Module B, EU-
type examination – combination of production type and design type  
Annex III, Module B1 Annex III, point 3.2, Module B, EU-
type examination – design type 
Annex III, Module C1 Annex III, point 4, Module C2 
Annex III, Module D Annex III, point 5, Module D 
Annex III, Module D1 Annex III, point 6, Module D1 
Annex III, Module E Annex III, point 7, Module E 
Annex III, Module E1 Annex III, point 8, Module E1 
Annex III, Module F Annex III, point 9, Module F 
Annex III, Module G Annex III, point 10, Module G 
Annex III, Module H Annex III, point 11, Module H 
Annex III, Module H1 Annex III, point 12, Module H1 
Annex IV ____ 
Annex V ____ 
Annex VI ____ 
Annex VII Annex IV 
____ Annex V EN 167   EN ____ Annex VI