MDR
Device
Basic UDI-DI & UDI-DI attributes
Basic UDI-DI set of data in UDI database
Principle: Each UDI-DI inherits the attributes of its linked Basic UDI-DI and devices DI
Basic UDI-DI UDI-DIs UDI-DIs
•Applicable legislation (MDR) (*)
•0. UDI-DI value (*)
•0b. UDI-DI Issuing Entity (*)
(container
•2. Basic UDI-DI value (*) •Secondary DI (value and issuing entity) package DI)
•2b Basic UDI-DI Issuing entity (*); •11.B. Reference, Article or Catalogue number (*)
•Device with Direct marking (Y/N) (*)
•6. Manufacturer SRN (*) •Direct marking UDI-DI value (*)
•5. Name and address of manufacturer •0. UDI-DI value
•Direct marking UDI-DI issuing entity (*)
•7. Name and address and SRN of AR •1. Quantity of device(s) (*) (*)
•9. Risk class (*) •3. Type of UDI-PI (*) • 0b. Issuing entity
•4. Unit of use UDI-DI (*)
•Implantable (Y/N) (*) (*)
•12. Clinical size (*)
•For IIb implantable: Suture, staple, •14. Storage/handling conditions •1. Quantity per
dental filling, dental brace, tooth •10-15. Name(s)/Trade name(s) (including package (*)
languages) •24. Status
crown, screw, wedge, plate, wire, pin,
•13. Additional product description
clip, connector (Y/N) •22. URL for additional information
•Measuring function (Y/N) (*) •16. Labelled as single use (Y/N) (*)
•Reusable surgical instrument (Y/N) •17. Maximum number of reuse (*)
(*) •18. Device labelled as sterile (Y/N) (*)
•19. Need for sterilisation (Y/N) (*) (1) Nomenclature
•Active device (Y/N) (*) •20. Containing latex (Y/N) (*) decision:
•Intended to administer/remove a •21. CMR/Endocrine disruptor [Link]
medicinal substance (Y/N) (*) •23. Critical warnings or contra-indications sroom/documents/34264
•11. A. Name and/or, if applicable, •8. Medical device nomenclature (CND) code (1)
•24. Status
device model that identifies the •25. (A.2.6) Reprocessed single-use (Y/N) (*)
device(s) with this BASIC UDI-DI in the •26. (A.2.12) Annex XVI (*) (*) may not be changed
technical documentation and/or •27. (A.2.13) In the case of devices designed and
certificate or declaration of conformity manufactured by another legal or natural person as Mandatory
(Name and/or model shall be provided) referred in Article 10(15), the name, address and
contact details of that Natural/legal person Mandatory if applicable
Optional
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MDR
Other Device Data
Other Device Data attributes
Basic UDI-DI UDI-DIs
• A.2.7 Medicinal product Substance(s);
• A.2.8 Medicinal product Substance(s) derived from
•A.2.2 Certificate IDs (NB, type .. Link); human blood or human plasma;
•A.2.14 SSCP; • A.2.3 Member State of the Placing on the EU Market
of the Device (*);
•A.2.11 Clinical Investigations IDs (..link); • A.2.4 Member State(s) were the Device is made
•A.2.9 Presence of Human tissues/Cells available in the Country;
(Y/N) (*);
•A.2.10 Presence of Animal tissues/Cells
(Y/N) (*);
•A.2.7 Presence of medicinal product
substance (Y/N) (*);
•A.2.8 Presence of medicinal product
substance derived from human blood or
human plasma (Y/N) (*);
•Special device types: Software (Y/N),
contact lenses (Y/N) … (max one choice)
(*);
•System which is a device in itself (Y/N)
(*);
•Procedure pack which is a device in itself
(Y/N) (*);
(*) may not be changed
Provided by NB or for certificate ID under Art Mandatory
29(3) provided by manufacturer and Mandatory if applicable
confirmed by NB
Optional
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MDR
System or Procedure Pack
Basic UDI-DI & UDI-DI attributes
Basic UDI-DI set of data in UDI database
Principle: Each UDI-DI inherits the attributes of its linked Basic UDI-DI and devices DI
Basic UDI-DI UDI-DIs UDI-DIs
Applicable legislation (MDR) (*)
•0. UDI-DI value (*) (container
•UDI-DI issuing entity (*)
•[Link] UDI-DI value (*) •Secondary DI (value and issuing entity) package DI)
•2b Basic UDI-DI issuing entity (*); •11.B. Reference, Article or Catalogue number
(*) •Issuing entity (*)
•6. SPPP SRN (*) •3. Type of UDI-PI (*) •0. UDI-DI value (*)
•5. Name and address of SPPP •14. Storage/handling conditions •1. Quantity per
•9. Risk class (highest risk class of •10-15. Name(s)/Trade name(s) (including package (*)
the device components ) (*) languages)
•13. Additional product description
•24. Status
•11. A. Name and/or, if applicable,
•22. URL for additional information
system or procedure pack model
•18. Labelled as sterile (Y/N) (*)
that identifies the product with this •19. Need for sterilisation (Y/N) (*)
BASIC UDI-DI in the statement •23. Critical warnings or contra-indications
drawn in accordance with Art 22.1 •8. Medical device nomenclature (CND) code (1)
•2.a. Indication of specific medical •24. Status
purpose of the System or Procedure
pack; (1) Nomenclature
decision:
•System or Procedure pack [Link]
(S/P)(*); sroom/documents/34264
(*) may not be changed
Mandatory
Mandatory if applicable
Optional
Version April 2019
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