Base de connaissances réglementaires

Guides pratiques sur les rôles de conformité externalisés et la stratégie d'entrée sur le marché européen — commencez par les propres répertoires de ce portail, puis approfondissez avec la bibliothèque complète de guides EUCertify.

Sur ce portail

Find a PRRC

Outsourced PRRC (Person Responsible for Regulatory Compliance) under MDR/IVDR Article 15.

Find a VAT Fiscal Representative

VAT fiscal representation requirements for non-EU businesses registering in the EU.

Directory Coverage & Data

Countries and standards covered by listed regulatory consultants.

EU Market Entry for Non-EU Manufacturers

The three compliance pillars: CE marking, Authorized Representative, and importer obligations.

CE Marking Process: Step-by-Step Guide

Conformity assessment routes, technical documentation, and Declaration of Conformity.

Technical Documentation for CE Marking

What the technical file must include and common mistakes to avoid.