CEN/CLC/TR 14060:2014

Medical device traceability enabled by unique device identification (UDI)

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.

Rückverfolgbarkeit von Medizinprodukten durch Unique Device Identification (UDI)

Traçabilité des dispositifs médicaux à l’aide de l’identification unique des dispositifs (UDI)

Sledljivost medicinskih pripomočkov, omogočena z enotno identifikacijo pripomočka (UDI)

To tehnično poročilo opisuje trenutno stanje na področju sledljivosti medicinskih pripomočkov v Evropi in opredeljuje ključne elemente za vzpostavitev celovitega evropskega sistema sledljivosti, ki bi zagotovil popolno sledljivost na ravni posameznega bolnika.
To tehnično poročilo se uporablja za medicinske pripomočke, aktivne medicinske pripomočke za vsaditev ter diagnostične medicinske pripomočke in vitro, vključno z njihovimi dodatki. Druge naprave, ki so izdelane po meri ali namenjene za klinične raziskave, ter diagnostični medicinski pripomočki in vitro, ki jih izdelajo zdravstvene ustanove in se uporabljajo za oceno delovanja, ne spadajo na področje uporabe tega dokumenta.

General Information

• Status: Withdrawn
• Publication Date: 02-Dec-2014
• Withdrawal Date: 05-Jul-2022
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3/WG 3 - Traceability
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Jul-2022
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST-TP CEN/CLC/TR 14060:2015 - Medical device traceability enabled by unique device identification (UDI)

Relations

• Replaces: CR 14060:2000 - Medical device traceability
• Effective Date: 10-Dec-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/CLC/TR 14060:2015
01-marec-2015
1DGRPHãþD
SIST CR 14060:2001
6OHGOMLYRVWPHGLFLQVNLKSULSRPRþNRYRPRJRþHQD]HQRWQRLGHQWLILNDFLMR
SULSRPRþND8',
Medical device traceability enabled by unique device identification (UDI)
Rückverfolgbarkeit von Medizinprodukten durch Unique Device Identification (UDI)
Traçabilité des dispositifs médicaux à l’aide de l’identification unique des dispositifs (UDI)
Ta slovenski standard je istoveten z: CEN/CLC/TR 14060:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST-TP CEN/CLC/TR 14060:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/CLC/TR 14060:2015

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SIST-TP CEN/CLC/TR 14060:2015


TECHNICAL REPORT
CEN/CLC/TR 14060

RAPPORT TECHNIQUE

TECHNISCHER BERICHT
December 2014
ICS 11.040.01 Supersedes CR 14060:2000
English version
Medical device traceability enabled by unique device
identification (UDI)
Traçabilité des dispositifs médicaux à l'aide de Rückverfolgbarkeit von Medizinprodukten durch Unique
l'identification unique des dispositifs (UDI) Device Identification (UDI)


This Technical Report was approved by CEN on 24 May 2014. It has been drawn up by the Technical Committee CEN/CLC/TC 3.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.






CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2014 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. CEN/CLC/TR 14060:2014 E
worldwide for CEN national Members and for CENELEC
Members.

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SIST-TP CEN/CLC/TR 14060:2015
CEN/CLC/TR 14060:2014 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Terms and definitions .5
3 Manufacturer .8
3.1 Internal traceability – Key elements.8
3.2 External traceability – Key elements .8
4 Intermediate trading partner .8
4.1 General .8
4.2 Internal traceability – Key elements.8
4.3 External traceability – Key elements .9
5 Internal traceability – Key elements for users .9
6 Sharing information .9
6.1 General .9
6.2 Technical - Interoperability . 10
Annex A (informative) International activity on UDI . 11
A.1 Global activity on UDI . 11
A.2 European activity on UDI .
...