To sell electronics and electrical equipment in the European Union, manufacturers need to identify the correct legislation for their products.
Overall, electronics can fall under at least one of these Directives:
- Electromagnetic Compatibility (EMC) Directive
- Radio Equipment Directive (RED)
- Low Voltage Directive (LVD)
After identifying the applicable law, manufacturers must be sure that their products are compliant before selling them in the European Union. The European Union has some of the highest safety and health requirements, which all manufacturers – EU and non-EU – must meet.
What are the RED, EMC, and LVD Directives?
Electromagnetic Compatibility (EMC) Directive
Electronics and electrical devices emit electromagnetic waves, influencing each other when interconnected or close to each other. The Electromagnetic Compatibility (EMC) Directive ensures that side effects generated by such interactions are under control. The EMC Directive does not cover safety requirements, which are mandatory in the EU. Therefore, products falling under the scope of the EMC Directive must comply with the safety requirements of another directive as well, typically the Low Voltage Directive (LVD) or General Product Safety Directive (GPSD). Some examples of EMC products are computer monitor, AC adapters, certain batteries, electronic circuits, etc.
Radio Equipment Directive (RED)
If your electronic devices intentionally transmit radio waves, they likely fall under the Radio Equipment Directive (RED) scope. Some examples of RED products are devices with GPS, Bluetooth, and Wi-Fi, such as smartphones, televisions, remote controls, routers, laptops, etc. The obligations described in the Radio Equipment Directive (RED) cover safety and health as well as electromagnetic compatibility requirements.
Low Voltage Directive (LVD)
Lastly, the Low Voltage Directive (LVD) covers electrical equipment operating with an input or output voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current. Some examples of LVD products are household appliances, cables, lamps, chargers, and similar. The obligations indicated in the LVD cover safety and health requirements.
European Authorised Representative and Technical Documentation for electronics
Firstly, appointing a European Authorised Representative (EAR) is highly recommended. Among others, an EAR keeps your documentation available to Competent Authorities, accommodates their requests, and fulfils related post-market surveillance activities.
Secondly, every product should have a complaint Technical Documentation that must contain the elements listed in the respective Directive(s) that apply to your product. Some key components of the Documentation are test reports, Declaration of Conformity, design calculations, manufacturing drawings, and harmonised standards.
Once your file is compliant and you have distributors based in the EU, you can place your products on the Union market.
EU economic operator mandatory since July 2021
According to the Market Surveillance Regulation, non-EU manufacturers must have an economic operator based in a EU country. This applies also to online sellers. When the importer will not act as an economic operator under this Regulation, non-EU manufacturers are obliged to appoint an authorised representative. The authorised representative will fulfil the responsibility under the post-market surveillance.
Obelis can act as your authorised representative and regulatory consultant for your products in the European Union and United Kingdom. Contact us today!
References:
Eur-Lex. (2014). Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility. Retrieved on 15/12/2022.
Eur-Lex. (2014). Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment. Retrieved on 15/12/2022.
Eur-Lex. (2014). Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits. Retrieved on 15/12/2022.
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