Unique Device
Identification (UDI) is a new requirement set out in Article 27 and Article 24 (Unique Device Identification system) of both the new Medical Device Regulation (EU) 2017/745
(MDR) and the In Vitro diagnostic
Device Regulation (EU) 2017/746 (IVDR), respectively. It consists of an alphanumeric or
numeric code that should be present on the label of each medical device. The
first part of the code is known as the device identifier (UDI-DI) which is specific to a manufacturer and device while the second part is known as the production identifier (UDI-PI) which identifies the unit of device production.
The EU Medical Device Coordination
Group (MDCG) has recently published five new sets of guidance documents on
medical device UDI for manufacturers since last March, when basic UDI-DI and
future EU medical device nomenclature guidances were released (Asphanews, May
2018). These guidance documents intend to clarify specific EU UDI requirements
set out in the MDR and IVDR. In particular, these guidances provide information
on how to implement the UDI requirement on systems, procedure packs and medical
device Software, descriptions/definitions of the UDI core elements,
clarifications concerning Article 16 of the MDR/IVDR (Cases in which obligations of manufacturers apply to importers,
distributors or other persons) and provisional considerations regarding
language issues associated to the UDI database.
These guidance documents can be found in the following links:
·MDCG 2018-4 Definitions/Descriptions and formats of the UDI core
elements for systems or procedure packs https://ec.europa.eu/docsroom/documents/31925
·MDCG 2018-5 UDI Assignment to Medical Device Software https://ec.europa.eu/docsroom/documents/31926
·MDCG 2018-6 Clarifications of UDI related responsibilities in relation
to Article 16 https://ec.europa.eu/docsroom/documents/31927
·MDCG 2018-7 Provisional considerations regarding language issues
associated with the UDI database https://ec.europa.eu/docsroom/documents/31928
Manufacturers should be
aware of these and future guidance regarding UDI requirements since UDI will be
progressively become a mandatory element for the CE marking of medical devices,
according to medical device risk class (2021, 2023 and 2025 for implantable and
Class III devices, Class IIa and Class IIb devices, and Class I devices,
respectively).
