Version 2
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.
Introduction
The new Medical Device Regulations 745/2017 and 746/2017 introduce a Unique Device Identification (UDI) system for medical devices.
Main provisions related to the establishment of the UDI system are contained in Chapter Ill and Annex VI of the two medical device Regulations.
The main features of the UDI system and relevant obligations for operators will be provided in a dedicated Q/A paper to be published by the Commission in spring 2018.
This guidance is intended to provide a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.
The Basic UDI-DI
The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.
It is independenUseparate from the packaging/labelling of the device and it does not appear on any trade item.
Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.
In accordance with Annex XII of the medical device Regulations, the scope of the certificates shall unambiguously identify the device or devices covered. The scope of EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include, together with the Basic UDI-DI, a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure and the risk classification.
Each of the abovementioned certificates shall identify and cover all devices associated with the same Basic UDI-DI, that is referred to in that certificate.
The association between different Basic UDI-Dls, where applicable, shall be identified through the technical dossiers.
In accordance with Annex IV of the two Regulations, the declaration of conformity shall contain the Basic UDI-DI and the product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity.
Changes of UDl-01
A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilization before use, quantity of devices provided in a package, critical
warnings or contra-indications (e.g. containing latex or DEHP), CMR/Endocrine disruptors1 2.
AUDI-DI shall be associated with one and only one BasicUDI-DI.
WARNING: This guidance does not address requirements for reprocessed devices, systems or procedure packs, software, Annex XVI, nor for cases of parallel trade or own brand labelling. Specific requirements for those products are addressed in specific guidance.
It should be noted that a new regulatory decision classifying an existing product as CMR/Endocrine disruptor might not result in a new UDI-DI for products already containing that substance. The decision on whether to assign a new UDI-DI should be based on the conformity assessment of the product with regard to the impact of the information provided and the significance of the change.
Specific attention shall be paid to the fact that changes of colour or language might also require a new UDI DI when those changes might lead to misidentification of product or change the product safety/performance. For example:
A- Change of colour coding of e.g. connectors, latex-free surgical gloves, blood tubes
8- Two identical self-testing devices, that exist in parallel and cannot be substituted due to local labelling requirements (IVD Article 10(10) of Regulation 746/2017), requires different UDI-Dls
Specifications of EU designated issuing entity should be used as a reference source to identify other possible examples.