Non-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.
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.