Export medical devices to the EU: rules, labels and duty

Rules to check before you export medical devices to the EU (2), each with its official source. Must clear before you sell: Main rule for medical devices.

Official sources checked between 2026-10-09 and 2026-10-15

Duty and FTAs: 0% duty for Korean-origin industrial goods under the EU–Korea FTA (cuts completed July 2016): write an origin declaration on the invoice; above €6,000 per shipment only an approved exporter may. Anti-dumping duties, if any, are separate. trade.ec.europa.eu, checked 2026-10-09

This is not legal or tax advice. Rules and rates change, so confirm with the official source and a local authority, your importer or an expert before you sell.

• Main rule for medical devices: Medical Device Regulation (EU) 2017/745: CE marking (a notified body for Class IIa and up, and for the sterile, measuring or reuse aspects of Class I devices that are sterile, have a measuring function or are reusable surgical instruments), an EU authorised representative, UDI and EUDAMED registration. eur-lex.europa.eu, checked 2026-10-09
• EU: LED skin devices and the medical device rules: In the EU, high-intensity light equipment for skin treatment falls under the Medical Device Regulation even without a medical purpose (Annex XVI). The Commission's guidance MDCG 2023-5, which is not legally binding, names LED face masks for skin rejuvenation as Class IIb examples, and the common specifications (Regulation 2022/2346, Annex VI) allow devices for home use only for hair removal. A home-use LED mask sold for rejuvenation or wrinkles may therefore not be placed on the EU market; get a notified body's or specialist's opinion before you quote EU buyers. Microcurrent devices are outside that annex. Your company does it · health.ec.europa.eu, checked 2026-10-15
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• Same country, other products: Phones & telecom equipment
• Same country, other products: Wooden tableware
• Sources: eur-lex.europa.eu, checked 2026-10-09
• Sources: health.ec.europa.eu, checked 2026-10-15
• Sources: trade.ec.europa.eu, checked 2026-10-09

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