Your guide to EU MDR 2017/745 for non-EU manufacturers
QCRA Global team · · 6 min read
Selling medical devices in Europe means meeting the EU Medical Device Regulation. This guide explains the main steps for manufacturers based outside the EU.
Why an EU Authorized Representative matters
Manufacturers outside the EU need a representative inside the EU who can act on their behalf with regulators and keep key documents available.
What your representative helps with
This includes keeping your compliance on track, preparing the EU Declaration of Conformity, and supporting post-market surveillance and vigilance.
Connect your quality system
A quality management system such as ISO 13485 gives you the processes and records that MDR expects. A cloud eQMS keeps them traceable and audit-ready.