When manufacturers of machinery and electronics equipment and products in Latvia are able to export with their technology, they must be able to ensure technical compliance with the regulated market requirements.
How to do it? What is CE marking and will it be enough? How to prepare it? Who can request it? When to start thinking about certification?
The purpose of this article is to briefly answer these questions by introducing the most important processes for adapting equipment to the export market.
What is CE marking?
The CE mark is not just a sticker, in EU member states and the EEA it serves as a safety guarantor that indicates compliance with safety requirements and ensures free circulation of products in the EU.
CE marking is a mandatory requirement in the EU market, which is controlled by market surveillance authorities. Equipment that meets the minimum safety and health protection requirements set by the directives applicable to a specific product can be CE marked.
The minimum safety and health protection requirements are determined by the applicable EU directives, the compliance of which can be demonstrated by the harmonized standards of the directive, but the use of the standards is not mandatory to demonstrate compliance. The EU stipulates that the conformity of products can be demonstrated by a method as good as or even better than that specified in the harmonized standards.
The CE marking is confirmed by the accompanying documentation, which proves the conformity of the products. Often this is a voluminous technical file on the construction of the product, sometimes a test inspection report prepared by the manufacturer.
The punishment for not having a CE mark and not complying with the relevant directives ranged from a ban on the use of the product and a fine, to imprisonment.
Will the CE mark be enough?
It depends on the chosen market. It will be enough for the European market, but here it is important to remember that the CE mark is not just a sticker, because legally the consumer of the product must make sure or request CE mark compliance documents when importing the product. In practice, this is rarely followed, but with a growing trend, especially in the public sector. The consumer often engages an instance of a notified body that monitors product compliance and can request declarations of compliance with specific directives or harmonized standards. Thus ensuring against potential risks using technology that does not meet local safety standards.
The most critical situation can arise when equipment compliance is requested after an accident involving the equipment. In such situations, the judiciary will request technical documents that would certify the authenticity of the CE marking.
Can the manufacturer prepare the CE marking himself?
Manufacturers of mechanical engineering and electronic equipment to which the product applies:
- Machinery Directives (2006/42/EU)
- Electromagnetic Compatibility Directives (2014/30/EU)
- Low Voltage Directives (2014/35/EU)
- Radio Directives (2014/53/EU)
can prepare the CE marking for the equipment themselves, but with the exceptions described in each directive separately, for example, in the Machinery Directive, such an exception is the list of equipment in Annex 4, whose certification must involve notified bodies.
In order to practically outline the path to the preparation of the CE marking, the necessary steps are listed below:
Step 1. Identify EU directives applicable to the product, they can be Machinery (2006/42/EC), EMC (2014/30/EU), Low Voltage (2014/35/EU), Radio (2014/53/EU), etc.
Step 2. Identify the harmonized standards applicable to the product. Harmonized standards are technical specifications designed to enable manufacturers to comply with applicable directives with their technology.
Step 3. Carry out a conformity assessment for your product by preparing conformity documentation for each directive and harmonized standard applicable to the technology. Including – test documentation, calculations, risk analysis to assess potential risks and indicate appropriate risk mitigation methods.
Step 4. Provide a declaration of conformity with the signature of an authorized person of the company, indicating compliance with directives and harmonized standards.
Step 5. Place the CE mark on the equipment in a visible place, indicating the identity of the manufacturer, the address of the manufacturer or its representatives.
When to start thinking about certification?
The short answer is the sooner the better. For example, if the appropriate directives and applicable standards are not followed during the design process of the equipment, then there is a very high possibility that the equipment is not safe for operation, its accompanying technical documentation is incomplete and the financial calculations related to the equipment are incorrect. Therefore, the device cannot be marked with the "CE" mark and it is not valid for the European Union market. It is relatively more expensive to repair the equipment when it has already been exported at the request of consumers. In addition, corrections are not always possible, so for example, based on experience, we can recall cases where the EMC conformity assessment for a specific electronic solution requires 2 years, because its design was not carried out in accordance with the requirements of the directive.
By following the applicable standards during the design process, you can be sure that the equipment can be safely marked with the "CE" mark and that there will be no unforeseen complications when it is exported. You will also be a more reliable partner for customers if the accompanying technical documentation is prepared in accordance with the requirements of the directives, which is a seal of high quality.
Depending on the complexity of the equipment, such a process may be too resource-intensive and complicated for a manufacturer without experience. Working with directives and standards requires a certain approach, which allows you to work effectively with the wide range of standards and at the same time to quickly recognize the potential risks of the equipment and to be widely familiar with the technological solutions with which to reduce the risks.
For this reason, we recommend that you start thinking about certification right away and ask for help!
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