CE marking

CE marking is not a general requirement for everything sold in the European Union. It applies only to products inside the scope of at least one New Approach directive or regulation, and the CE marking requirements for your product come from that instrument, each with its own threshold. The Low Voltage Directive 2014/35/EU covers electrical equipment rated 50 to 1000 V AC or 75 to 1500 V DC, so a 24 V DC sensor is outside it. The Pressure Equipment Directive 2014/68/EU starts at a maximum allowable pressure above 0.5 bar. A product outside every instrument must not carry the mark, and applying it anyway is itself an infringement.

The common mistake is assuming one directive applies when several do. A mains-powered device with a Wi-Fi module falls under the Radio Equipment Directive 2014/53/EU, which absorbs the safety and electromagnetic compatibility requirements, so it is not separately marked under the LVD and the EMC Directive 2014/30/EU. Take the radio out and the opposite is true. A machine with a motor sits under the Machinery Directive 2006/42/EC and the EMC Directive, and the electrical safety objectives of the LVD reach it through the Machinery Directive, so a machine is not declared under the LVD separately. Getting the list wrong produces a genuine test report against the wrong legislation.

The mark is the visible end of three documents. The technical file holds the design records, the risk assessment, the standards applied and the test evidence, and must stay available to market surveillance authorities for ten years after the last unit is placed on the market. The EU Declaration of Conformity is a signed statement naming the product, each directive and the standards applied. The instructions and safety information must be in a language of every member state where the product is sold.

Testing is the shortest part. The technical file is where projects stall, because it needs design records the manufacturer may never have written down, and a risk assessment that reasons about the product rather than restating the standard.

Self-assessment (Module A) is the default route in most directives. A Notified Body becomes mandatory in two situations. Either the directive names your category for third-party assessment, or you have not applied the harmonised standards in full and cannot claim presumption of conformity. The Machinery Directive lists the first kind in Annex IV. Its successor, Regulation (EU) 2023/1230, applies from 20 January 2027 and goes further: for the six categories in its Annex I Part A, self-assessment is withdrawn even where harmonised standards are applied in full.

Harmonised standards are voluntary, but applying them is what lets you self-declare. The Radio Equipment Directive is the live example. Delegated Regulation (EU) 2022/30 activated the cybersecurity requirements in Article 3(3)(d), (e) and (f) of the RED from 1 August 2025, and the EN 18031 series that covers them is listed in the Official Journal with restrictions. A product inside one of those restrictions goes to a Notified Body for that requirement.

A manufacturer established outside the European Union needs an economic operator inside it. Article 4 of Regulation (EU) 2019/1020 on market surveillance says that products under the LVD, EMC, RED, Machinery, Toy Safety and Pressure Equipment legislation may only be placed on the market if a manufacturer, importer, authorised representative or fulfilment service provider established in the Union is named and holds the declaration of conformity. The General Product Safety Regulation (EU) 2023/988, applicable from 13 December 2024, extends the same duty to consumer products outside any directive.

This is a legal appointment: the representative must be named in the documentation and on the product or its packaging, and answers to market surveillance. The United Kingdom has been a separate market since 2021, with its own UKCA marking and its own responsible person.

The directives that most electrical and connected products fall under have their own pages: the Low Voltage Directive, the EMC Directive, the Radio Equipment Directive and RoHS.

Scope and third-party requirements come from the consolidated text of each instrument in force on the day you place the product on the market. The Machinery Regulation, the GPSR and the RED cybersecurity rules all have application dates between December 2024 and January 2027, so a directive analysis from 2023 is out of date.