European
Compliance Platform
European
Compliance Platform
You have a product. You want to sell it in Europe. This guide maps the full compliance route — from identifying your obligations to building the right team of EU partners — for manufacturers based outside the European Union.
This guide is written for manufacturers and exporters 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 their products on the EU market legally and sustainably.
If you are a startup, OEM, or established manufacturer exploring EU market access for the first time, this guide gives you the compliance roadmap you need before you start spending on consultants, testing, and certification.
The European Union operates a product safety and conformity system that applies 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 let them handle compliance — for most regulated product categories, you carry the manufacturer's legal obligations, even from outside the EU.
The EU compliance system is built around three pillars:
The EU compliance route depends entirely on what your product is. The EU has sector-specific legislation for most product categories. Your first task is to identify which directive(s) or regulation(s) apply:
MDR 2017/745 (non-IVD) and IVDR 2017/746 (diagnostics). Risk-based classification. NB required for Class IIa+.
Low Voltage Directive, EMC Directive, Radio Equipment Directive. Usually self-declaration with testing.
Machinery Regulation 2023/1230 applies from Jan 2027. Safety-critical machinery requires NB involvement.
Regulation 2016/425. Category I (self-declaration), Category II and III require NB certification.
CPR 305/2011. Performance declarations based on harmonised standards and European Technical Assessments.
Toy Safety Directive, REACH, RoHS, GPSR. Requirements vary significantly by category.
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 established in the EU that acts as your regulatory contact point for authorities, Notified Bodies, and market surveillance.
The AR obligation applies to non-EU manufacturers under:
The AR is named in your Declaration of Conformity and on the product label. They carry legal responsibility alongside you — which is why choosing a competent, experienced AR is critical.
If you sell through an EU-based distributor or importer, your EU importer also carries compliance obligations under most EU product regulations. The importer must:
CE marking demonstrates that your product meets the essential requirements of applicable EU legislation. The route varies by product:
→ See full guide: CE Marking Process — Step-by-Step
If your product is a medical device or IVD, you must register in EUDAMED — the European database for medical devices. Registration covers actors (manufacturer, AR, importer) and devices (UDI, device-level data, certificates). Your EU AR manages EUDAMED registration on your behalf.
| Country | Key Consideration | Priority Sectors |
|---|---|---|
| Turkey | Turkey-EU Customs Union covers most industrial goods; medical devices require TITCK registration in addition to CE | Medical devices, machinery, electronics |
| Israel | MOH Israel registration required for medical devices alongside CE; ILAC recognised labs for testing | Medical devices, electronics, defence |
| United Kingdom | Post-Brexit: EU AR required for EU market; separate UKCA/UKRP for Great Britain market | Medical devices, machinery, consumer goods |
| China | Strong manufacturing base seeking EU market access; NMPA and CE are separate registrations | Electronics, PPE, medical devices, machinery |
| USA / Canada | FDA/Health Canada approval does not replace CE marking; separate EU route required | Medical devices, in vitro diagnostics |
| India | CDSCO and BIS approvals are separate from EU CE; EU AR required for medical devices | Medical devices, electronics, textiles |
| Ukraine / Serbia | EU accession process underway; current position is non-EU — EU AR required | Machinery, electronics, food contact materials |
Entering the EU market as a non-EU manufacturer typically requires a team of specialist partners. Depending on your product and markets, this may include:
Mandatory regulatory contact for most sectors. Legal point of contact for EU authorities.
Guides strategy, manages technical documentation, NB liaison.
Provides 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.
For IFU, labelling, and technical documentation in local languages.
Submit a request on ECP — tell us about your product, your target EU market, and your current situation. We match you with the right AR, testing lab, consultant, or Notified Body.
Submit Your Request — Free