You manufacture outside the EU and want to sell in Europe. This guide maps every regulatory obligation you must meet — from CE marking and Authorized Representative to labelling, EUDAMED, and post-market duties — so you can build your EU market entry plan without surprises.
This guide is written for manufacturers, OEMs, exporters, and brand owners located outside the European Union — including companies in Turkey, Israel, the United Kingdom (post-Brexit), Ukraine, Serbia, USA, Canada, China, Japan, South Korea, India, and all other non-EEA countries — who want to place products on the EU market legally and sustainably.
The EU applies its product safety and conformity system to all products sold within the EEA, regardless of where they are manufactured. As a non-EU manufacturer, you cannot simply ship products to an EU buyer and consider your compliance obligations discharged. For most regulated product categories, you carry the manufacturer's legal obligations — even from outside the EU.
The EU compliance route depends entirely on what your product is. Sector-specific legislation governs most product categories:
MDR 2017/745 (non-IVD) and IVDR 2017/746 (diagnostics). Risk-based classification. Notified Body required for most classes.
Low Voltage Directive (LVD), EMC Directive, Radio Equipment Directive (RED). Mostly self-declaration with testing.
Machinery Regulation 2023/1230 (applies from Jan 2027). High-risk categories require Notified Body.
PPE Regulation 2016/425. Category I self-declaration; Category II and III require Notified Body certification.
General Product Safety Regulation (GPSR) 2023/988. Applies to all consumer products. EU Responsible Person mandatory from Dec 2024.
CPR 305/2011. Performance declarations based on harmonised standards and European Technical Assessments.
For most regulated product sectors, non-EU manufacturers must appoint an EU Authorised Representative (AR) before placing products on the EU market. The AR is a legal entity in the EU that acts as your regulatory contact point for authorities, Notified Bodies, and market surveillance.
The AR obligation applies under: MDR 2017/745 (Article 11), IVDR 2017/746 (Article 11), GPSR 2023/988 (Article 16), Toy Safety Directive, and others. The AR is named in your Declaration of Conformity and on the product label.
→ See full guide: EU Authorized Representative Under MDR | EAR Services Guide
CE marking demonstrates your product meets the essential requirements of applicable EU legislation. The route depends on product risk level:
→ See full guide: CE Marking Process — Step-by-Step
If you sell through an EU-based distributor or importer, your EU importer also carries compliance obligations. They must:
If your product is a medical device or IVD, registration in EUDAMED — the European database for medical devices — is mandatory. Registration covers actors (manufacturer, AR, importer) and devices (UDI, device data, certificates). Your EU AR manages EUDAMED registration on your behalf.
| Country | Key Point | Priority Sectors |
|---|---|---|
| Turkey | Customs Union covers industrial goods; medical devices also need TITCK registration | Medical devices, machinery, electronics |
| Israel | MOH Israel registration required for medical devices alongside CE | Medical devices, electronics |
| United Kingdom | Post-Brexit: EU AR required for EU market; separate UKCA/UKRP for Great Britain | All regulated categories |
| China | NMPA and CE are separate registrations; EU AR required | Electronics, PPE, medical devices |
| USA / Canada | FDA/Health Canada approval does not replace CE marking | Medical devices, IVDs |
| India | CDSCO and BIS are separate from CE; EU AR required for medical devices | Medical devices, electronics |
EU market entry as a non-EU manufacturer typically requires a team of specialist partners:
Mandatory for most regulated sectors. Legal contact point for EU authorities.
Guides strategy, manages technical documentation, Notified Body liaison.
Test reports for applicable harmonised standards.
Third-party assessment for higher-risk products. Select early — capacity is limited.
Commercial route to market with compliance obligations.
IFU, labelling, and technical documentation in local languages.
Submit a request on ECP — tell us about your product, target EU market, and current compliance situation. We match you with the right AR, testing lab, consultant, or Notified Body.
Submit Your Request — Free