The Pressure Equipment Directive (97/23/EC) is due to be replaced by a brand new Directive that has been aligned to the New Legislative Framework. The arrival of the new Directive (2014/68/EU) will mean that manufacturers will need to review their CE marking procedures and documentation for pressure equipment. The Directive will be implemented into force in two stages;
– Article 13 on Classification shall enter into force on the 1st June 2015
– The remainder of the Directive will enter into force on the 19th July 2016
To help manufacturers prepare for this forthcoming change and to help them understand their requirements, we have compared the current Directive to the new and listed the mains changes between the two.
Whilst the new Directive has been re-formatted and there are a lot of changes, most of these changes related to how sections have been reworded and/or re-numbered and/or re-ordered. There are actually very few changes in terms of conformity requirements and it should be easy to prepare for the change in 2016. The most significant changes are likely to evolve around updating documentation. I have given an overview of the key sections of the new Directive below:
The scope remains the same, however the Directive is now supported with additional definitions. The new definitions cover generic terms and they are unlikely to have any significant impact for manufacturers already CE marking under the current PED.
The Directive has been rewritten to make the requirements much clearer for the different types of economic operators. The Directive now identifies the 4 types of operators (Manufacturers, Importers, Distributors and Authorised Representatives). For manufacturer’s there are no real changes and the process is the same as what is understood for the current Directive.
Classification & Assessment Modules:
The groups remain, but there is further information on group 1 (to align PED with the CPL Regs (Classification, Labelling & Packaging of Substances and Mixtures Regulation – Reg (EC) No. 1272/2008). This is Article 13, which comes into force on the 1st June 2015, which will be in advance of the rest of the Directive, which is due to come in on the 19th July 2016.
The classification charts remain the same.
The modules have had slight tweaks:
- Module A1 has been renamed to A2
- Module B1 has been incorporated into Module B
- Module C1 has been renamed to C2
All modules have very subtle changes. The main changes are around updating references, adjusting the order of the requirements and giving slightly more guidance (for example giving a more detailed list of what should be included with the technical documentation).
The most significant change is around the quality system requirements mentioned in modules, D, D1, E, E1, G, H and H1.
The new Directive requires:
- some additional basic additional information to be included with applications
- the member of auditing team shall also have knowledge about the application of PED.
- the auditing team should also audit the technical documentation.
The other change is the that module B and B1 have been combined into one module. The terms ‘EC Type-Examination’ and ‘EC Design-Examination’ have been replaced with the term ‘EU-Type Examination
Essential Health & Safety Requirements:
No real changes and the wording predominately remains the same. The changes:
- 2.2.3 (b) Under the calculation for pressure containment: Material Characteristics to be considered – ‘impact strength’ has been replaced by ‘bending rupture strength’
- 3.3 (b) Under markings: The requirement to provide ‘the product group’ has been changed to ‘the fluid group’ (understood to be the same thing)
The Declaration has changed, as follows:
- The title has been slightly altered to ‘EU Declaration of Conformity’
- It is optional to choose to assign a number to the Declaration
- Further information has been given on the type of information that required to be provided to enable to the product to be identified (suggest that an image could be used)
- A statement must be included to say that the Declaration has been issued under the sole responsibility of the manufacturer
- Another statement is required to be included to say that the object being declared is in conformity with the relevant Legislation
- And finally the Directive number has been changed, so the new Directive number (2014/68/EC) must be declared.
Any other changes?
In short no, all of the other changes can be summarised by the comments in the overview.
Link to the Directive: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:189:FULL&from=EN
If you need any help with the Pressure Equipment Directive, then please get in contact.
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