MDCG_2024-14_Guidance on the implementation of the Master UDI-DI solution for contact lenses
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MDCG 2024-14
Guidance on the implementation of
the Master UDI-DI solution for
contact lenses
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 2 of 12
Medical Devices
Medical Device Coordination GroupDocument
MDCG 2024-14
Contents
Introduction and scope................................................................................................................................ 3
1. Terminology .............................................................................................................................................. 4
2. The Master UDI -D .............................................................................................................................. 5
2.1 Master UDI-Dl assignment...............................................................................................................6
2.1.1 Standard contact lenses............................................................................................................ 6
2.1.2 Made to order (MtO ) contact lenses .................................................................................... 7
3. Master UDI-Dl assignment on container package , packaging levels and packaging
variant .................................................................................................................................................... 9
4. Vigilance reporting ............................................................................................................................ 10
4.1 Vigilance reporting for Regulation contact lenses.................................................................... 10
4.2 Vigilance reporting for legacy contact lenses .......................................................................... 10
5. Timeline for the application of the Master UDI -DI....................................................................... 1
6. Device registration in Eudamed.......................................................................................................12
Page3 of 12
Medical Devices
Medical Device Coordination Group Document MDCG 2024-14
Introduction and scope
The introduction of the Unique Device Identification (UDI)system referred to in Article 27 of
Regulation(EU)2017/745 on medical devices(MDR)¹aims to ensure an adequate level of
identification and traceability with respect to medical devices.Basic UDI-Dls,UDI-Dls and UDI-
Pls shall be assigned (in compliance with the rules of the designated issuing entities)by
manufacturers to all devices,other than custom-made devices,prior to their placement on the
market.
To further strengthen and enhance traceability and recording of UDls,manufacturers shall
register Basic UDI-Dls and UDI-DIs in the European Database on Medical Devices
(Eudamed)² .
For contact lenses,which are devices presenting a high level of individualisation('highly
individualised devices'),the assignment of a Master UDI-Dl has been foreseen according to
Annex VI,Part C,Section 6.6.1 MDR,as amended by Commission Delegated Regulation (EU)
2023/2197 on Master UDI-DI for contact lenses³.
Even though all economic operators have to contribute to an appropriate level of traceability
according to Article 25 MDR,the main responsibility to apply the means to achieve proper
identification and traceability of the device lies with the manufacturer.
This document aims to provide guidance in the implementation of Master UDI-DI rules for
contact lenses as regards its structure,assignment,labelling and registration in Eudamed.
NOTE: this document is intended to be read in conjunction with Regulation (EU)2017/745 on
medical devices(MDR),Commission Delegated Regulation (EU)2023/2197 and other MDCG
Guidance documents on UD4.
1Regulation(EU)2017/745 of the European Parliament and of the Councilof 5 April 2017 on medical devices,
amending Directive 2001/83/EC,Regulation(EC)No 178/2002 and Regulation(EC)No 1223/2009 and
repealing Council Directives 90/385/EEC and 93/42/EEC(OJL1175.5.2017,p.1.Current consolidated version
ELI: https://eur-lex.europa.eu/eli/reg/2017/745/2024-07-09)
2 https://health.ec.europa.eu/medical-devices-eudamed en
3 Commission Delegated Regulation(EU)2023/2197 of 10 July 2023 amending Regulation(EU)2017/745 of the
European Parliament and of the Council,as regards the assignment of Unique Device Identifiers for contact
lenses (OJ L,2023/2197,20.10.2023,ELI:http://data.europa.eu/eli/reg del/2023/2197/oi)
4 https://health.ec.europa.eu/medical-devices-sector/new-requlations/quidance-mdca-endorsed-documents-and-
other-guidance en#sec18
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MDCG2024-14GuidanceontheimplementationoftheMasterUDI-DIsolutionforcontactlensesThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup(MDCG)establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGiscomposedofrepresentativesofallMemberStatesanditischairedbyarepresentativeoftheEuropeanCommission...
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作者：冒牌货
分类：专业资料
价格：60质量币
属性：12 页
大小：362.25KB
格式：PDF
时间：2026-01-09
