Regulatory Knowledge Base

Regulatory Knowledge Base

Practical guides on outsourced compliance roles and EU market-entry strategy — start with this portal’s own directories, then go deeper with EUCertify’s full guide library.

On this portal

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.