EUROLAB, which has helped to document thousands of products for compliance with European directives including the machinery directive for years, can perform the evaluations and tests required for your product, either on site or in our laboratory.
The Machinery Directive is a European law and requires that its equipment comply with the applicable technical requirements listed in Annex I. These technical requirements are called Primary Health and Safety Requirements (EHSRs).
The first step in accordance with Annex I is to conduct a risk assessment on the equipment to determine which Annex I EHSRs apply to the equipment and therefore must be met. The process at this point is point-to-point, to prove and document how the equipment is compatible with the selected EHSRs, or to determine which compatible EN standards can be applied to the equipment and then apply the applicable parts. harmonized standards with valid EHSRs.
This technically means that you have the option to demonstrate the compliance of each applicable EHSR or to apply the applicable part of an EN standard. The most practical method is to evaluate and test using harmonized EN standards; because compliance with this provides the “conformity assumption” defined in Article 7 of the Machinery Directive. This is what we do, and if there is a risk that is not covered by a harmonized EN standard, we will consider it specially and technically.
EN ISO 12100: 2010 is the only harmonized Machinery Directive standard for non-explosive atmosphere equipment risk assessment and is the first step mentioned above. EUROLAB can make an assessment of your equipment regarding EN ISO 12100: 2010 and any other compatible EN standards that may apply.
The next step after your machine is evaluated, tested (if necessary) and harmonized is to complete and sign the EC declaration of conformity. This is a one-page document listing the machine and specific details about the machine, as well as the EN standards used to evaluate it and the relevant directives that you claim conformity to the machine. The EU declaration of conformity must accompany every machine sent to the EU and keep a copy of each for ten years. The document must match a particular machine via its serial number. We can prepare the EC declaration of conformity for you.
You also need to quickly put together the technical file containing the information needed to prove compliance with any directive that applies to the machine. This file is used by European authorities to evaluate the compatibility of the machine, but you should not send it to Europe with your machine. The Requirement Machine Directive is described in detail in Annex VII, and your customer is not entitled to this file unless otherwise agreed. This requirement is ten years from the date you send the machine to Europe. We can help you with this and keep it safe for you
The Machinery Directive also requires your EC declaration of conformity to list an address about the community land (EU) that the authorities can write to make a formal request for the technical file. This is a responsibility that the authorized EU Representative may legally assume for you.
You can contact us immediately to discuss your European CE mark project.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
