EU Authorised Representative

Article 11 representation under the MDR and IVDR

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EUDAMED

Registered actor

Article 11

MDR and IVDR

PRRC

In-house

EU + TR

One mandate

1 day

Authority response

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What we do

All services

EU Authorised Representative

EUDAMED Registration

Türkiye Market Access

Where representatives differ

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EU Authorised Representative

Authorised representative process from inquiry to EUDAMED registration

Our process

How it works

Inquiry

Review

Mandate

EUDAMED

Representation

Regulatory responsibility

Article 15(6) requires an authorised representative to have permanent and continuous access to a person responsible for regulatory compliance. Ours is a partner of the firm, with a deputy for continuity, and carries the same responsibility for Medex's own devices.

About Us

Regulatory notes

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Daha sonra tekrar deneyin

Yayınlanan yazıları burada göreceksiniz.

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