In order to bring a machine in for use in Europe it must be CE marked to all applicable directives. Spiers provide CE Marking for machinery services within the UK and Europe. These services include, though are not limited to, CE Marking for compliance with;
Directives are European Law putting a responsibility upon the member states to bring in to law, through issue of their own law, the content of the directive. In the UK this is achieved through the issue of Regulation.
There are many ways a person can become the manufacturer and therefore have to take on the CE Marking of a machine. Not all of these criteria are very obvious. Here are a few plain English examples to get you started with CE Marking machines, however always refer to the Machinery Directive for a full and complete answer.
If you change the machine so that it is performing a function outside of that for which it was originally designed. i.e. outside its intended limits of use.
If you alter speeds, feeds, loads etc beyond that for which it was originally designed.
You can make changes/repairs to many aspects of the machine without becoming the manufacturer however if your changes introduce a new risk and then you must ensure that the controls in place comply with European requirements.
When machines are arranged for a common purpose, share control functions above that of monitoring and there is some risk at their interfaces then they are considered as one machine. If you complete this work or commission it to be done, you are now likely to be the manufacturer of that machine making you the responsible person for CE Marking it using the Machinery Directive and other directives as applicable.
You have a machine that needs to be CE marked before it is brought in to use or put on the market. Perhaps it is a new machine, perhaps it is a modified machine or perhaps it is a number of machines working together for a common purpose such as a production line. You will need to complete the conformity assessment procedure for each applicable directive i.e. Machinery Directive 2006/42/EC (and others as needed).
We provide you with a suite of CE Marking Machinery services to the Machinery Directive designed to support you in achieving CE Machine Certification.
We are Machine Safety Experts with a great knowledge of the Essential Health and Safety Requirements (EHRSs) of the Machinery Directive and harmonised EN standards. Our services include conformity planning for large assemblies of machinery, design risk assessments, CE Audits, CE EMC testing, CE Marking Machinery Certification and acting as the authorised representative. We provide our services both internationally and across the UK, including London, Birmingham, Glasgow, Liverpool, Leeds, Sheffield, Edinburgh, Bristol and Manchester.
Before placing machinery on the market and/or putting it into service, the manufacturer or their authorised representative shall fulfill the duties under article 5 of the Machinery Directive.
Spiers can act as your Authorised Representative. The Authorised Representatitve will be contacted with regards to the machine for enforcement or surveillance activity.
When we sign that Declaration as the authorised representative we are taking on a role that shares the risk and gives you piece of mind. Spiers do not operate with impunity. We are bound by the law of the land and we will stand shoulder to shoulder with our clients if the need were to arise to defend our actions in CE Marking Machinery.
Spiers are highly trained consultants and have substantial experience, across many industries, with projects large and small. By far and away the most common root cause for a problematic process when CE Marking Machines, is the absence of planning and arrangements.
At Spiers we take a communicative, plain speaking approach with our clients. Spiers will consult with the stakeholders to provide a compliance and conformity plan that ensures clarity and efficiency in the CE Marking of Machines.
The output of this phase of work should identify the following in order to improve the likelihood of a successful outcome with minimal confusion:
The Machinery Directive allows a manufacturer of machinery to use an authorised representative during the conformity process. This person may sign the Declaration of Conformity on your behalf as well as contributing to other duties under Article (5) of 2006/42/EC.
As part of our CE Marking of Machinery services we will offer to act as your Authorised Representative upon completion. This does not absolve the manufacturer of their responsibility, instead it spreads the responsibility to an third party who, in the case of Spiers, are an independent UK based Machine Safety Expert.
At Spiers we take this role very seriously and will not act as an authorised representative unless the machine has been audited in detail and found to be in compliance with the applicable Directives and EN standards.
Spiers will hold a copy of your technical construction file (TCF) for 10 years from the date the last unit covered by this Declaration was manufactured. This is a legal requirement of The Machinery Directive, Annex VIIA so Spiers are removing this burden from your organisation.
"In-house machinery does not require CE Marking because I am not selling it and CE Marking of machinery is all about trade"
Sorry to bust the myth but CE marking of Machinery is applicable to in-house machinery. This is due to a term in the Machinery Directive that covers putting machines in to use rather than just making them available.
OK, so what do I do...?
Well in particular, we advise that you make sure your arrangements for change management are up to scratch. This sets out that any modification of machinery will be completed within arrangements for ensuring its continued compliance and conformity with EU Directives and current EN Standards. If the changes being made are substantial then a conformity assessment is required. The scope of that assessment depends on the limits of the substantial change and its effect. Where the change or its effects are not substantial then it is sufficient to simply make certain that the machine continues to conform with the Work Equipment Directive (WED). In the UK the WED is implemented by PUWER 98 so an inspection under this, supported by the resulting machine risk assessments is sufficient.
Where there is a substantial change during its lifetime a machine may require a CE Marking conformity process. A substantial change is one that modifies the performance, function, level or type of risk, or technology used to reduce risk.
Where substantial changes occur within an assembly of machinery then the limits of the conformity assessment can be determined by identifying the parts of the assembly that are not affected by the modification and excluding these from the assessment. Evidence is required for the technical construction file for any conformity assessment.
Substantial changes require a new Declaration to be made.
After any change, it is the duty of the user of the machine to ensure that it continues to conform with PUWER 98 (UK implementation of 2009/104/EC).
If you are in any doubt then give us a call for some free advice...
The application of a CE Mark indicates that ALL applicable directives have been met by the manufacturer. Therefore, it is critical to understand which Directives apply to a any particular machine and the conformity related actions that are required be fore affixing it.
Note: A CE Mark can only be applied to a product if a CE Marking Directive is applicable to the product. A full list of EU Directives can be found on the EU website ec.europa.eu.
Note: A direct link to the page is not provided due to it constantly changing (The irony is not lost on us).
The primary directives for Machinery are:
If you would like to take advantage of our CE Marking for machinery services (whether you are in the UK or Europe), or perhaps you would just like to know more, leave your contact details at the top of the page and we will get back to you shortly.