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MDCG 2018-4 Definition and Formats of UDI Core Elements For Procedures Packs

This document provides definitions and formats for core elements that must be included in the UDI database for medical device systems or procedure packs, according to the EU Medical Device Regulation. It lists 24 pieces of information that the producer must provide, including the quantity per package, UDI-DI, medical purpose, expiration/manufacturing dates, contact information, risk class, trade names, product descriptions, storage conditions, warnings, and status on the market. The document was endorsed by the Medical Device Coordination Group established under EU law to provide guidance on medical device regulations.

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144 views3 pages

MDCG 2018-4 Definition and Formats of UDI Core Elements For Procedures Packs

This document provides definitions and formats for core elements that must be included in the UDI database for medical device systems or procedure packs, according to the EU Medical Device Regulation. It lists 24 pieces of information that the producer must provide, including the quantity per package, UDI-DI, medical purpose, expiration/manufacturing dates, contact information, risk class, trade names, product descriptions, storage conditions, warnings, and status on the market. The document was endorsed by the Medical Device Coordination Group established under EU law to provide guidance on medical device regulations.

Uploaded by

Leil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Medical Devices

Medical Devices Coordination Group Document MDCG 2018-4

MDCG 2018-4
Annex: UDI database
Definitions/Descriptions and formats
of the UDI core elements for systems
or procedure packs

October 2018

This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is
composed of representatives of all Member States and it is chaired by a
representative of the European Commission.

The document is not a European Commission document and it cannot be regarded


as reflecting the official position of the European Commission. Any views expressed
in this document are not legally binding and only the Court of Justice of the European
Union can give binding interpretations of Union law.

Page 1 of 3
Medical Devices
Medical Devices Coordination Group Document MDCG 2018-4

In accordance with Article 29(2) and Annex VI, Part B of the MDR, in the case of
systems and procedure packs, the system or procedure pack producer shall
provide to the UDI database the UDI-DI and all of the following information1:

1. quantity per package configuration (meaning the quantity of systems or


procedure packs in a package, whenever applicable)
2. the Basic UDI-DI as referred to in Article 29 (MDR) and any additional UDI-
DIs,
2a. Indication of specific medical purpose of the system or procedure pack
3. the manner in which the system or procedure pack is controlled (expiry date
or manufacturing date, lot number, serial number),
5. name and address of the system or procedure pack producer (as indicated
on the label),
6. the SRN of the system or procedure pack producer
8. The medical device nomenclature code as provided for in Article 26 (MDR)2
9. risk class (to be intended as the highest risk class of the device components
of the system or procedure pack),
10. if applicable, name or trade name,
11.A. name or, if applicable, system or procedure pack model associated with
the BASIC UDI-DI in the statement drawn in accordance with Article 22.1 of
the MDR
11.B. reference or catalogue number, or product number found on the system
or procedure pack label or accompanying packaging to identify a system or
procedure pack
13. additional product description,
14. if applicable, storage and/or handling conditions of the system or
procedure pack (as indicated on the label or in the instructions for use),
15. if applicable, additional trade names of the system/procedure pack,
18. labelled sterile (y/n) (meaning that the system or procedure pack in its
entirety is labelled as sterile),
19. need for sterilisation before use (y/n)
22. URL for additional information, such as electronic instructions for use
(optional),
23. if applicable, critical warnings or contra-indications

1
Please note that format and definition of all UDI data elements are provided at
https://ec.europa.eu/docsroom/documents/28669
2
Applicability of this data element to systems and procedure packs is to be determined at the time of
designation of the future EU nomenclature for medical devices (foreseen end of 2018/beginning 2019).

Page 2 of 3
Medical Devices
Medical Devices Coordination Group Document MDCG 2018-4

24. status of the system or procedure pack (on the market, no longer placed
on the market, recalled, field safety corrective action initiated).

Whenever a label is referred to, the label of the entire system/procedure pack shall
be meant, in accordance with Article 22(5) of Regulation 745/2017.

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