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Notes · hardware

The CE mark is self-issued. That doesn’t make it easy.

Whether you sell one unit to one customer or ten million to companies, a product on the EU market needs to meet every EU rule that applies to it. For most products you declare that yourself and put the CE mark on. Working out which rules and standards apply is your job too.

This is an overview and not legal advice. Standards get new editions and dates move, so check the current list of harmonised standards in the Official Journal, and talk to a test lab early.

  1. 01

    Every product

    • REACH restricts substances in anything made of physical material, not only electronics.
    • General Product Safety Regulation (EU) 2023/988, for consumer products, since December 2024. It covers safety risks no specific rule covers, and asks for traceability and an EU-based responsible person.
  2. 02

    If it contains electronics

    • RoHS (2011/65/EU): no lead, mercury and the rest of the list in electrical and electronic equipment.
    • EMC Directive (2014/30/EU). The standard depends on the product family: EN 55032 and EN 55035 for IT and multimedia, EN 55014 for household appliances and tools.
    • Low Voltage Directive (2014/35/EU), for 50–1000 V AC or 75–1500 V DC. Safety standards such as EN 62368-1 for IT and audio-video equipment, EN 60335-1 for household appliances. Below those voltages, safety is still required, through the GPSR or the radio directive.
    • WEEE: register as a producer in each country you sell to, and finance take-back.
  3. 03

    If it has a radio

    • Radio Equipment Directive (2014/53/EU) replaces the EMC and Low Voltage directives for the whole product. Radio standards by band: EN 300 328 for 2.4 GHz Wi-Fi and Bluetooth, EN 300 220 for sub-GHz short-range devices. EN 301 489 for EMC, EN 62368-1 for safety, and an RF exposure assessment.
    • Cybersecurity, since 1 August 2025, for radio equipment that connects to the internet: the EN 18031 series. The harmonised listing has restrictions, so read it before you count on self-assessment.
    • A certified radio module helps, but the product still needs its own assessment. Your antenna, enclosure and firmware are part of what gets tested. An FCC ID is for the US market and doesn’t count in the EU.
  4. 04

    If it has a battery

    • Battery Regulation (EU) 2023/1542, since February 2024. Batteries need their own CE mark and labelling. More duties phase in over the next years, including removability and a digital battery passport for e-bike and EV batteries, so check what applies on the date you ship.
    • IEC 62133-2 for portable lithium cells and batteries, ideally with a CB certificate. Buying cells that already have one saves a lot. EN 50604-1 for light electric vehicle batteries.
    • UN 38.3 is not part of CE, but without it you can’t ship lithium batteries by any carrier. The test destroys samples, so build them into the prototype run. IEC 62281 covers safe transport.
  5. 05

    If it plugs into the wall

    • Use a certified external power supply if you can. Then the supplier has already done most of the mains safety work. External supplies also have their own efficiency rules (EU 2019/1782).
    • Battery chargers you build yourself: EN 60335-1 with EN 60335-2-29.
    • Common charger rules (EU 2022/2380): many small portable devices must charge over USB-C and be sold without a charger as an option.
  6. 06

    If it’s an e-bike

    • EN 15194 for pedal-assisted bikes (EPAC): assistance up to 25 km/h and 250 W. Above that it’s a moped and needs type approval under Regulation (EU) 168/2013.
    • Machinery: EPACs fall under the Machinery Directive (2006/42/EC), which the Machinery Regulation (EU) 2023/1230 replaces from 20 January 2027.
    • ISO 4210, the general safety standard for bicycles, for the mechanical parts. Read it before you start designing.
    • Lights are national. In Germany they need StVZO approval (Straßenverkehrs-Zulassungs-Ordnung), and other countries have their own rules.

    From experience Over three years on the Noordung Boombox e-bike: regulation, a team from several disciplines, and a production run too small for the hardware world to take seriously. Reading the general bicycle standard, ISO 4210, at the start would have saved us a month.

Nabla, Samo Fortuna s.p.