Frequently Asked Questions
We have collated a comprehensive list of questions that we are asked. If we have made any omissions and you wish to add to this list, or if you would like to find out more about our services, contact us for more details.
- Are there other European Directives that might apply to my product?
- Do I need to have ISO9001?
- How do I get a CE certificate for my product?
- If I get a certificate from PAC how long will it be valid for?
- What if I want to makes changes to my product after I’ve received a certificate?
- Can my certificate be withdrawn?
- Can I use the PAC or UKAS logo?
- I’ve heard about self-certification, can I self-certify my product?
- Is my product covered by the Machinery Directive?
- Is there a European Standard that applies to my product?
- What do you mean by a technical file?
- What is an EC type-examination?
- What is an EC Notified Body?
- Where can get I get further help or guidance?
- What if I have a complaint?
Are there other European Directives that might apply to my product?
Complying only with the Machinery Directive 2006/42/EC often isn't enough. There are other environmental issues to consider, such as how much noise is emitted from the product, any radio interference it may emit (or be adversely affected by) and whether the machine is intended to be used in an area where explosive atmospheres are present. In this regard, you may need to refer to European Directives 2000/14/EC Noise Emissions for equipment used outdoors, 2014/30/EU Electromagnetic Compatibility (EMC) and 2014/34/EU Equipment for use in potentially explosive atmospheres.
Do I need to have ISO9001?
If you plan on producing several units following your initial prototype, you need to ensure that each subsequent product also complies with the requirements of the EC Directives. This means that you need the relevant internal control measures in place to ensure that, if the specification of the product does change, the product is still compliant. It is usually not essential that you possess ISO9001 certification however, you should ensure that you have adequate quality control procedures, which are documented, that cover for example engineering, manufacturing and purchasing processes.
How do I get a CE certificate for my product?
In order to put the CE mark on your product and sell it in Europe you must ensure that it complies with the requirements of all of the relevant European Directives. If your product is intended to lift goods or persons, or both, then it will likely fall within the scope of the European Machinery Directive.
Please contact PAC if you have a MEWP or other device for lifting persons you want to have certified. We can give you an idea of what will be involved in the process, what we need from you and an idea of costs.
If I get a certificate from PAC how long will it be valid for?
The Machinery Directive stipulates that EC type-examination certificates have a validity period of 5 years. You will therefore see an expiry date on the certification issued by PAC Ltd. Prior to this date, it is the responsibility of the manufacturer to request a review of the certification by the notified body to ensure that it still applies. PAC Ltd will then undertake a review to ensure that the product complies with the latest ‘state of the art’, taking into account any new and revised European harmonised standards. Indeed, PAC Ltd have a duty to inform manufacturers of revisions to standards and new standards, which we usually do via our newsletter ‘PAC Overview’.
What if I want to makes changes to my product after I’ve received a certificate?
The certificate covers all products manufactured to the same specification as the initial representative example. If the manufacturer wishes to make any changes on a product covered by the EC type-examination certificate, the Machinery Directive requires that they notify the Notified body. PAC Ltd can provide guidance on what impact changes will have on the certification - sometimes additional testing may be required, although often a desktop review of documentation will suffice. We encourage manufacturers to contact us in good time if they contemplate making any changes, modifications, additions or limitations to the product. Once we are satisfied that the modified product continues to meet the relevant safety requirements we will issue an addendum to the original EC type-examination certificate.
Can my certificate be withdrawn?
PAC Ltd are within their rights to withdraw an EC type-examination certificate should they have good reason to. We will of course adequately advise manufacturers if we feel that this action is necessary and provide an opportunity to rectify any shortfall in requirements.
Can I use the PAC or UKAS logo?
You may refer to the name Powered Access Certification Ltd, the address, the notified body number 0545 and the EC type-examination certificate number on your EC Declaration of Conformity.
It is not permitted to reproduce the PAC or UKAS logos without specific written permission from PAC Ltd or UKAS, respectively.
I’ve heard about self-certification, can I self-certify my product?
Self-certification is a procedure whereby a manufacturer declares that his product complies with the requirements of the relevant Directive, without the assistance of a notified body. With regard to the Machinery Directive, if the product falls within certain categories of equipment however, the manufacturer must apply all of the requirements of an applicable harmonised European standard. If the requirements are not or cannot be fully met then the manufacturer must involve a notified body, and the product may need to be submitted for an EC type-examination.
Is my product covered by the Machinery Directive?
'Machinery' is roughly defined in the Machinery Directive 2006/42/EC as 'an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application'. This assembly may be stand-alone or be connected on site for its power source, be permanently installed on a means of transport or in a building or structure, or may even be only partly completed. If the product is intended for lifting loads by direct human effort this is also covered by the Directive.
Is there a European Standard that applies to my product?
European standards are being developed and revised on a continual basis by technical committees throughout Europe. It can often be difficult to identify which standard or standards are applicable to your product. The European Union publish what is termed an 'Official Journal', in which all harmonised standards are listed, that is those which may be used in order to comply with the relevant EC Directives. With regard to lifting equipment there are many standards already published which cover many different types of equipment. However, if your product does not directly fall within the scope of a European standard, it may be necessary to apply the requirements of one or more standards.
What do you mean by a technical file?
A technical file is a document, which can either be held in a hard copy format or files on your computer, which is used to demonstrate that the product complies with the relevant European Directive. Normally, a file would contain documentation such as drawings, calculations, risk assessment, test reports and user instructions. The nature and extent of the documentation depends very much on the type and complexity of the product. The manufacturer is responsible for creating the technical file, which must be retained for at least 15 years following the date of manufacturing, or after the last unit has been produced.
What is an EC type-examination?
An EC type-examination is a process undertaken by an EC Notified Body in order to verify that the manufacturer's product does indeed comply with the relevant European Directive(s). The notified body will review the manufacturer's technical file and must retain a copy for at least 15 years following the date of manufacturing, or after the last unit has been produced. The notified body will, normally, also wish to witness tests of the product and undertake a physical inspection. If it is deemed that the product in question meets the relevant requirements of the European Directive(s) then an EC type-examination certificate will be issued.
What is an EC Notified Body?
An EC notified body is an organisation that has been designated by the government of a European country as being an expert in that particular product field. The organisation must be able to demonstrate that they have the necessary expertise, impartiality and procedures to enable them to undertake EC type examinations for certain types of products. Some notified bodies are appointed to undertake type examinations on many different types of equipment, whereas other specialise in certain types of product.
Where can get I get further help or guidance?
Hopefully, the information on this page will have answered some of your questions. If you require further guidance please do not hesitate to get in touch with us. Feel free to give us a call or use our Contact page.
What if I have a complaint?
Any complaints or appeals against certification decisions should be made in writing to the Managing Director at the above address. All complaints and appeals will be duly considered and individually answered.