Which EU directives apply to your product?

No. CE marking is only required when a product falls within the scope of an EU harmonisation act that mandates it — such as the Machinery, Low Voltage, EMC, Radio Equipment, Medical Device, IVDR, PPE, Toy, Pressure Equipment, Construction Products, Lifts, Gas Appliances, Measuring Instruments or Recreational Craft legislation. Many everyday consumer goods (textiles, furniture, most kitchenware) carry no CE marking at all; they are governed by the General Product Safety Regulation (EU) 2023/988, which sets safety duties but does not require CE marking.

Machinery Regulation (EU) 2023/1230 starts to apply on 20 January 2027 and repeals the Machinery Directive 2006/42/EC on the same date. The cutover is determined by when the machine is placed on the EU market: before 20 January 2027 the 2006 Directive applies; on or after that date the 2023 Regulation applies. The new Regulation introduces a revised list of high-risk machinery (the former Annex IV) and updated rules on digital documentation and substantial modification, so confirm which side of the cutover your placing-on-market date sits on.

Only RED. The Radio Equipment Directive 2014/53/EU incorporates the essential health-and-safety (Low Voltage) and electromagnetic-compatibility (EMC) requirements for radio equipment, so a product with an intentional radio transmitter is assessed under RED and the Low Voltage and EMC Directives are not cited separately. This tool shows LVD and EMC as superseded when RED is triggered, to make the precedence explicit.

A notified body is required where the relevant act prescribes third-party conformity assessment: examples include PPE Category II and III, medical devices class IIa/IIb/III (and class I sterile/measuring for the sterile/metrology aspect), IVDs class B/C/D, high-risk standalone AI, lifts, measuring instruments and gas appliances, and radio equipment where no harmonised standard is fully applied. Class I non-sterile medical devices, IVD class A, PPE Category I and most self-declared electrical products do not need a notified body. Construction products instead follow the AVCP system declared for the product.

If you manufacture outside the EU and place a CE-marked or consumer-facing product on the EU market, you generally need an EU-established economic operator — an authorised representative for many regulated products, or an EU-based importer/responsible person — identified before the product is placed on the market. Selling without one is a blocking compliance gap for the affected acts. The exact operator and duties depend on the act; appoint one ahead of your launch rather than treating it as a post-launch fix.

The general rule across the New Legislative Framework is 10 years from the date the last unit of the product is placed on the EU market. Medical devices under the MDR (Reg (EU) 2017/745) require 15 years for implantable devices and 10 years for other devices; IVDs under the IVDR (Reg (EU) 2017/746) require 10 years. Keep the EU Declaration of Conformity and the technical file available for the relevant market-surveillance authority throughout that period.

No. It is a deterministic applicability estimator that maps your answers to the EU harmonisation acts most likely in scope, with each act citing its EUR-Lex source. It does not classify your product for you, does not draft the technical file or Declaration of Conformity, and does not certify compliance. Use the result to brief a notified body or qualified counsel, and re-check against the live regulation before filing — the harmonisation table carries a last-verified date and stops producing verdicts when it goes stale.