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Tell us what your device needs and we forward the request to independent MDR and IVDR providers who work on it.

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Tell us what your device needs and we forward the request to independent MDR and IVDR providers who work on it.

What do you need help with?

ClassificationTechnical documentation and GSPRClinical or performance evaluationNotified-body preparationEU authorised representativePRRCEUDAMED and UDIPost-market surveillance and vigilanceQuality management system and eQMSTrainingOther

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IVDR Guide is run independently of the European Commission, the Medical Device Coordination Group, notified bodies and national competent authorities. It explains the MDR and the IVDR and does not replace regulatory or legal advice for a specific device.