Legacy Device UDI Submissions: Issues, Risks and Recommended Best Practices

An important distinction is that legacy devices should not automatically be treated as conventional MDR/IVDR UDI submissions. Legacy device registration follows specific EUDAMED identification arrangements, including EUDAMED DI and EUDAMED ID, as applicable. The manufacturer’s existing product identifiers and historical records must be carefully assessed before data entry.

Probable Issues During Legacy Device Submissions

Identification and UDI-related discrepancies

• Confusion between Basic UDI-DI, UDI-DI, EUDAMED DI and EUDAMED ID.
• Legacy products may not have been assigned a UDI under the previous Directives.
• Existing catalogue numbers, REF numbers and internal product codes may not match the identifiers expected in EUDAMED.
• Multiple variants may incorrectly be grouped under one device record.
• Duplicate registrations may occur when different departments submit the same product under slightly different descriptions.

Incorrect legacy device classification

• Products may be incorrectly classified as legacy devices without confirming eligibility under the transitional provisions.
• Devices without the necessary valid Directive certificates may be incorrectly included.
• Products already transitioned to MDR/IVDR may be submitted again as legacy devices.

Incomplete or inconsistent product information

Common discrepancies include:

• Manufacturer name and address not matching the registered Actor information.
• Incorrect or outdated SRN details.
• Inconsistent device trade names and model references.
• Missing intended purpose or device description.
• Incorrect EMDN nomenclature selection.
• Missing or inconsistent risk classification.
• Differences between EUDAMED information, product labels, certificates and technical documentation.

Certificate and supporting-document issues

• Expired, suspended or incorrectly referenced Directive certificates.
• Certificate numbers entered incorrectly.
• Incorrect linkage between the device and its notified body.
• Inconsistent manufacturer details across certificates and EUDAMED.
• Insufficient evidence supporting the device’s legacy status.

Best Practices, Preventive Actions and Submission Checklist

Establish a verified legacy device master list

Before initiating submissions, prepare a consolidated product master list containing:

• Device trade name and model/REF number.
• Manufacturer name and SRN.
• Applicable Directive (MDD, AIMDD or IVDD).
• Original certificate number and validity status.
• Device risk classification.
• Existing identification numbers.
• EUDAMED DI requirements, where applicable.
• EMDN code.
• Current EU market status.

Perform a reconciliation against the approved product catalogue and technical documentation.

Perform identification and data reconciliation

Establish a clear relationship between:

• Existing REF/catalogue number.
• Legacy device identification.
• EUDAMED DI.
• EUDAMED ID.
• Basic UDI-DI and UDI-DI, where relevant to a Regulation device.

Do not generate or substitute identifiers without checking the applicable EUDAMED legacy device data requirements.

Maintain data consistency

Ensure that information entered in EUDAMED is consistent with:

• Approved technical documentation.
• Product labels and Instructions for Use.
• Declaration of Conformity, where applicable.
• Notified Body certificates.
• Internal product master data.
• Existing regulatory submissions.

Legacy device registration in EUDAMED presents potential challenges relating to product identification, regulatory eligibility, data consistency and system validation.

The most effective way to minimise submission errors is to establish a controlled process supported by a verified product master list, documented legacy eligibility assessment, accurate identification mapping and independent review.