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CEN/CLC/TR 14060:2014

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical device traceability enabled by unique device identification (UDI)

Withdrawn date

08-26-2022

Published date

12-03-2014

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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Manufacturer
4 Intermediate trading partner
5 Internal traceability - Key elements for users
6 Sharing information
Annex A (informative) - International activity on UDI
Bibliography

This Technical Report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level.This Technical Report applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories. Other devices which are custom-made or intended for clinical investigations and those in vitro diagnostic medical devices which are manufactured in health institutions and for performance evaluation are out of the scope of this document.

Committee
CEN/CLC/JTC 3
DevelopmentNote
Supersedes CR 14060. (01/2015) Supersedes UNE CR 14060. (04/2015)
DocumentType
Technical Report
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
Supersedes

Standards Relationship
S.R. CEN/CLC/TR 14060:2014 Identical
NEN NPR CEN CLC/TR 14060 : 2014 Identical
UNE-CEN/CLC/TR 14060:2014 Identical

ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 28001:2007 Security management systems for the supply chain Best practices for implementing supply chain security, assessments and plans Requirements and guidance
EN ISO 16054:2002 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
765/2008 : 2008 COR 1 2015 REGULATION (EC) NO 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 9 JULY 2008 SETTING OUT THE REQUIREMENTS FOR ACCREDITATION AND MARKET SURVEILLANCE RELATING TO THE MARKETING OF PRODUCTS AND REPEALING REGULATION (EEC) NO 339/1993 (TEXT WITH EEA RELEVANCE)
ISO 9001:2015 Quality management systems — Requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN ISO 22005:2007 Traceability in the feed and food chain - General principles and basic requirements for system design and implementation (ISO 22005:2007)
ISO 21849:2006 Aircraft and space Industrial data Product identification and traceability
ISO 22005:2007 Traceability in the feed and food chain General principles and basic requirements for system design and implementation

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