Being aware of the compliance path for each type of device is paramount when trying to bring a wide range of products to the European market. It is down to the manufacturer to determine the applicable standards and directives that apply to a given product before identifying the appropriate conformity assessment modules relating to the product classification. After this, a ‘quality system’ of post-market surveillance, vigilance, and traceability must be conducted continuously, along with risk analysis and safety assessment reports. In short, it is a rigorous process, and one that must be given due diligence. That is why, in this blog, we are going to try to clarify the compliance process for two product categories in particular – Electromagnetic Compatibility devices and Low Voltage Devices.
I. Low Voltage Devices
Under article 8 and annex IV of Low Voltage Directive 2009/95/EC, the compliance path for low voltage devices (LVD) is as follows:
- Technical Documentation: Before a product can be brought onto the European market, the manufacturer must first compile the correct technical documentation (the Technical File) in order to ensure the product is in line with each of the directive’s requirements.
- Appointing European Authorized Representative: Brand Owners (legally claimed manufacturer) located outside of the EU are obligated to appoint an EU entity to ensure compliance prior to market entry, to serve as the ongoing vigilance contact point, to provide the manufacturer with ongoing regulatory updates as the laws evolve for as long as the products remain available on the market.
- Declaration of Conformity: The manufacturer (or their appointed Authorized Representative) must also provide a Declaration of Conformity before an LVD product can be placed on the market.
- CE Marking: To be placed on the European market, a LVD device must also be affixed with a CE Marking. This process can only be carried out by the manufacturer or the designated Authorized Representative.
II. Electromagnetic Compatibility Devices
The compliance path for electromagnetic compatibility devices (EMC) follows the same first four steps as the LVC process (Technical Documentation, European Authorized Representative, Declaration of Conformity, and CE Marking) with two additional steps. Under directive EMC 2004/108/EC, products of this kind must also:
- Meet Protection Requirements for All Equipment: Under the directive, electromagnetic disturbance generated by products must not exceed the level above which radio and telecommunications equipment cannot operate as intended. Also, the level of immunity to electromagnetic disturbance of the product must operate without a significant level of degradation over time.
- Specific Requirements for Fixed Installations: Fixed installations are to be installed using best engineering practices, with due respect paid to the information on the intended use of its components.
It is extremely important to note, for both EMC and LVD devices, that failure to comply with directives and regulations under European law inside of the European Economic Area (EEA) can result in the removal of the product in question from the market, and possibly the revoking of the product’s CE marking.
For more information about the compliance path for Electromagnetic or Low Voltage devices, or to get a quote for our Authorized Representative/CE Marking services, please contact us today. Our team of regulatory, compliance, and legislative experts are always on hand to provide useful and knowledgeable advice.