India to EU compliance · Medical devices, diagnostics and pharmaceutical equipment
Medical devices from India to the EU
What EU route applies to an Indian medical-device manufacturer?
An Indian medical-device manufacturer must classify the device, use the prescribed conformity route, appoint an EU authorised representative and support the application with clinical evidence and post-market controls.
What an Indian company should prepare
- Classify the device and select the MDR or IVDR conformity route.
- Appoint the EU authorised representative and engage a notified body where required.
- Build the quality, clinical, registration and post-market evidence.
Read the complete requirement, EU article references and official sources
Relevant EU judgments
These judgments are selected from the EU register by fixed legal terms for this requirement. The list is updated when new judgments are read into the register.
- C-427/24 · Decided 2026-07-02 · Zentrale zur Bekämpfung unlauteren Wettbewerbs Frankfurt am Main eV v Diagramm Halbach Gmb
Reference for a preliminary ruling – Medical devices – Regulation (EU) 2017/745 – Obligations of distributors before making a device available on the market – Identification wristb - C-10/24 · Decided 2026-06-04 · Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
Reference for a preliminary ruling – Medical devices – Regulation (EU) 2017/745 – CE marking of a medical device falling under risk class IIa – Oil-free dry air compressors for the