MDR
MDR overview
Key MDR requirements, conformity assessment routes, documentation and common pitfalls.
For medical device and IVD manufacturers, we support regulatory strategy, documentation readiness and evidence planning under EU MDR (2017/745) and IVDR (2017/746).
Clear scope · Practical roadmap · Deliverables before onboarding · Response in 1–2 business days
Takes 2–3 minutes. No obligation.
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.
IVDR basics, classes A–D, performance evaluation, and compliance roadmap.
For CE marking and other EU product certification services, use our certification site.
EU AR services for medical devices are handled on getEAR.eu.
EU AR for medical devices (getEAR.eu) · Request EU AR service