Module 16 2022

05/09/2022

Unique Device Identification (UDI) – What is it?

Restricted number of reuses (if applicable);

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• License and/or marketing authorization or registration number (if required by the relevant regulatory authority)

• URL for additional information, e.g. electronic IFU (optional);

• Critical warnings or contraindications (as labelled) – if a particular regulation requires that the label of the device contains a critical warning or contraindication associated with the use of the device, eg:

• Labelled as containing latex? (Yes/No),

• Labelled as containing DEHP? (Yes/No)

• Labelled as MRI compatible? (Yes/No).]

• Date of discontinuance (referring to devices no longer placed on the market).

The Organisation for Professionals in Regulatory Affairs

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Unique Device Identification (UDI) – What is it?

• A new UDI-DI is required whenever there is a change that could lead to misidentification of the medical device and/or ambiguity in its traceability. • Brand Name • Device version or model • Clinical Size (including Volume, Length, Gauge, Diameter) • Labelled as single use • Packaged sterile • Need for sterilization before use • Quantity of devices provided in a package • Critical warnings or contraindications: e.g. containing latex or Bis (2-ethylhexyl) phthalate (DEHP) • New packaging configurations • Declared formulation or functionality (fit form or function) • Declared net content • Dimensional or gross weight change of 20% or more • Add or remove certification mark • Pre-defined assortment (eg Procedure pack a change to one or more components (including the supplier)) • New language version (not required for additional languages)

The Organisation for Professionals in Regulatory Affairs

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