Medical devices and diagnostics

A device may only be placed on the EU market with a CE marking issued on the route the Medical Device Regulation prescribes for its class, and a manufacturer outside the Union must appoint an authorised representative established in the EU whose mandate is set out in the regulation. Notified body involvement is the norm rather than the exception, and the clinical evidence requirement is what most Indian applications underestimate.

• Classify the device and identify the conformity assessment route; only class I non-sterile, non-measuring devices avoid a notified body.
• Appoint an EU authorised representative under Article 11 and keep the written mandate available; this is a device-specific role, not the GPSR one.
• Operate a quality management system to ISO 13485 and a post-market surveillance system with periodic safety update reporting.
• Compile the clinical evaluation and, for higher classes, the clinical investigation data; equivalence claims are scrutinised closely.
• Register the device and the economic operators in EUDAMED and apply the unique device identifier.

• Directive (EU) 2024/2853 on liability for defective productsArticle node

• Regulation (EU) 2017/745 on medical devices
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices

• What EU requirements apply to Indian medical device manufacturers?
• Does a CDSCO licence allow a device to be sold in the EU?

• Pharmaceuticals and EU GMP
• CE marking for Indian manufacturers
• General Product Safety Regulation
• All requirements
• Indian law against EU law

Sector

Medical devices, diagnostics, pharma equipment

Read date

2026-08-26

Register version

in-export-v1.0.0

Address

/in/export/medical-devices