Authorised representatives (EU REPs)
EU REP obligations are defined in MDR Article 11 and IVDR Article 11. Definitions appear in MDR Article 2(32) and IVDR Article 2(29).
2 docs tagged with "eu-rep"
View all tagsNon-EU & third-country access
Both MDR 2017/745 and IVDR 2017/746. This section covers requirements for non-EU manufacturers placing devices on the EU market, EU REP obligations, and how EU MDR/IVDR relates to non-EU regulatory systems.