EU: European Commission names UDI Issuing Agencies

The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers to comply with new regulatory requirements.

The four agencies will issue codes necessary for UDI, as described in the MDR.

UDI will be used on the Declaration of Conformity, Certificates, labels and for identification during distribution, use, incidents and Field Safety Corrective Actions (FSCA). This assignment will become effective on June 27, 2019 and will be valid for five years.

You can find the announcement in the Official Journal of the European Union (OJEU) on page 75.

 

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