MDR
MDR overview
Key MDR requirements, conformity assessment routes, documentation and common pitfalls.
Full-scope regulatory support for medical device and IVD manufacturers — from strategy and classification through technical documentation, evidence and Notified Body coordination.
If your company is located outside the EU, you may need EU Authorised Representative services to place products on the EU market and to respond to market surveillance requests.
EU-based manufacturer? Continue below — we can still support documentation and conformity assessment readiness.
Key MDR requirements, conformity assessment routes, documentation and common pitfalls.
End-to-end MDR (EU 2017/745) support from classification through Notified Body coordination.
Clinical evaluation plan, CER strategy and PMS/PMCF integration.
MDR device classification rules and borderline assessment.
The full spectrum of MDR compliance support services.
IVDR basics, classes A–D, performance evaluation, and compliance roadmap.
IVDR device classification rules and guidance.
Full-scope IVDR compliance support services.
Performance evaluation plan and PER strategy for IVDs.
Person Responsible for Regulatory Compliance — scope and setup support.
EUDAMED actor, device and certificate registration support.
For CE marking and other EU product certification services, use our certification site.
See our FAQ page for quick answers about MDR and IVDR.
EU AR services for medical devices are handled on getEAR.eu.
EU AR for medical devices (getEAR.eu) · Request EU AR service