DEVELOPMENTS IN THE PED AND GUIDELINES Ed Haynes (CEN Consultant)

RHETORICAL QUESTIONS  Do you have access to PED Guidelines in a language that you are familiar with?  Do you understand the status of the Guidelines?  Does your Member State encourage the use of the Guidelines?  Does your National representative circulate debate on guidelines and encourage you to participate in their development?  If you are a manufacturer exporting to a country which does not have strong views on Guidelines, can you ignore them?  Do Market Surveillance Authorities refer to the Guidelines?  Are there any parts of the PED that you consider would benefit from re-drafting?

Guidelines There are some 200 Guidelines to the PED They facilitate coherent and consistent implementation of Community legislation. They are not legally binding but represent interpretation agreed by: Member States and interested parties, for example: Users Manufacturers (via Orgalime) Notified Bodies CEN Consultant Therefore they would be difficult for Member States authorities and the Commission to ignore in Market Surveillance and their monitoring of Notified Bodies

Guidelines (continued) Drafted by the Working Party Guidelines (WPG) Agreed by the Working Group Pressure (WGP) Available in English, French, and German Hyper-text linked to the PED on website ure_equipment/ped/index_en.html ure_equipment/ped/index_en.html

Guidelines (continued) Answer issues that are commonly raised as problems Clarify the intent of the PED Explain the text of the PED where the wording is unclear to some readers Point out differences amongst linguistic versions of the PED Refer to other guidance such as the “Blue Guide” Provide examples (to be read widely for applicability to analogous situations) Try to capture the philosophy of those involved in early stages of the PED

Example of adoption in France Leads to 5 lists readable with Adobe Acrobat in French or English

Index des fiches CLAP Index byList number Serial number1 Guideline number2 Subject3 Clause of PED4 Keyword5

Alternative or parallel thinking Guidance exists for other Directives in a form which is easy to read and assimilate e.g. ATEX If the PED was re-written to address the issues raised as guidelines, would that answer all the issues?

Proposals for further development of the Guidelines Unlikely that the existing Guidelines will be “destroyed” They should be consolidated in a way which makes it easier to understand the philosophy and apply it to situations not yet addressed Encourage those with responsibilities under the PED to answer their own questions

Benefits This is a structured proactive approach The main strategic benefit is transferring the responsibilities to those implementing the PED Long-standing or contentious issues should be identified and separated from routine matters Users should benefit from an easier system which they can interrogate and self-help “instantly” Logistically this should reduce the workload of all involved with drafting and using Guidelines Overall, this should capture the collective memory and essence of the Directive

DISCUSSION Should the result be web-based and updated periodically at intervals of not less than one year? (At present guidelines are added or amended each time the WGP meets, several times a year)

DISCUSSION (continued) Should the result comprise: Text of the PED Articles and Annexes Consolidated guidance related to the Articles and Annexes, referring to principles and the Blue Guide as appropriate Frequently Asked Questions FAQs Examples to illustrate the approach; Links to harmonised standards and other sources of information

Pilot Exercise(s) The next 8 slides consider how revised guidance might help Give your views on which of the following examples would be most help to you

e.g. PED Article 1.3 Exclusions Explain the reasons for the exclusions, focusing on objectives of promoting trade, avoiding duplication in low-risk situations Explain the logic of when something is or is not mentioned as an exclusion. e.g. Should Pipelines exclusion 3.1 acknowledge the state of development of the gas supply infrastructure at the time of writing the PED, the existing coverage within National Legislation and the limited extent of further development of that infrastructure e.g. Should Vehicle exclusion 3.5 explain the differences between equipment mounted on vehicles and equipment necessary for them to function, also in relation to the older Directives cited

e.g. User Inspectorates Guidelines 3/10, 9/14 and 9/15 are referenced from PED Article 14 Is this sufficient with due regard to the optional nature of appointment of User Inspectorate in Member States?

e.g. Specific Guidelines 2/4 Is this clear and/or too long? Is this a case for the text of the PED to be re-negotiated as part of a revision? 8/15 Is this a mis-use of the purpose of guidelines and/or a useful pointer to standardisation?

e.g. Series 6 Manufacturing Why are there so many guidelines on permanent joining? Is the subject of welding not adequately covered in standards?

e.g. Series 5 Design If design is important, why are there so few guidelines on the subject? Are standards sufficiently developed to address the issues adequately?

e.g. Series 7 Material Are these guidelines a consequence of the PED being too onerous or do they impose more than the minimum required by the PED? Is the subject of material completely clear to all parties or is further guidance required?

e.g. Series 3 Assemblies Are the guidelines in this series clear? Do they explain the differences between designation of equipment comprising the assembly for purposes of conformity assessment (PED Annex III) and classification of risk (PED Annexes I &II)?

Horizontal Issues Is there relevant guidance associated with other Directives? Is that guidance in line with the present PED Guidelines?

Possible developments in the PED PUBLIC ENQUIRY REVIEWED User Inspectorates Merger with Simple Pressure Vessels Directive 87/404 INCORPORATE Essence of Guidelines Results of Market Surveillance WHEN?

Links to Standardisation Should use of EN/ EN.ISO be mandatory or optional? Are the risks of not using EN which include guideline concepts clear to those who choose not to use these standards?