What EU requirements apply to Indian medical device manufacturers?
Classify the device, engage a notified body for everything above class I non-sterile, appoint an EU authorised representative under Article 11, operate a quality management system and post-market surveillance, compile the clinical evaluation, and register in EUDAMED with a unique device identifier.
What has to be done
- 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.
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- Read date
- 2026-08-26
- Address
- /in/questions/medical-devices-eu-requirements
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