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
Published
Public Enquiry End Date
19-Apr-2014
Publication Date
28-Jan-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Jan-2015
Due Date
12-Mar-2015
Completion Date
29-Jan-2015

RELATIONS

Effective Date
01-Mar-2015

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SLOVENSKI STANDARD
SIST-TP CEN/CLC/TR 14060:2015
01-marec-2015
1DGRPHãþD
SIST CR 14060:2001
6OHGOMLYRVWPHGLFLQVNLKSULSRPRþNRYRPRJRþHQD]HQRWQRLGHQWLILNDFLMR
SULSRPRþND 8',
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 ................................................................................................................... 11

Bibliography ..................................................................................................................................................... 12

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SIST-TP CEN/CLC/TR 14060:2015
CEN/CLC/TR 14060:2014 (E)
Foreword

This document (CEN/CLC/TR 14060:2014) has been prepared by Technical Committee CEN-CENELEC/TC 3

“Quality management and corresponding general aspects for medical devices”, the secretariat of which is held

by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes CR 14060:2000.

The COMMISSION RECOMMENDATION 2013/172/EU of 5 April 2013 on a common framework for a unique

device identification system of medical devices in the Union should be used as common guideline and was

used in the developing this document.
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SIST-TP CEN/CLC/TR 14060:2015
CEN/CLC/TR 14060:2014 (E)
Introduction
Benefits of Tracking and Tracing.

Traceability of medical devices throughout the whole supply chain (finished goods to patient) contributes to

patient safety and safety of users by facilitating:
a) a reduction of medical errors linked to misuse of the device;
b) improved incident reporting;
c) efficient recalls and other field safety corrective actions (FSCA);

d) efficient post market actions e.g. by manufacturers and competent authorities;

e) supply chain efficiencies, including better distribution control, stock management and reimbursement;

f) detection of counterfeit products when they enter the supply chain, and
g) compliance to environmental regulations.

The current regulatory framework for medical devices does not include specific provisions on traceability.

However, the proposal from the European Commission for a regulation of the European Parliament and of the

Council on medical devices , include provisions on traceability of medical devices and in vitro diagnostic

medical devices, in order to improve patient health and safety.

This follows significant efforts that have been and are continuing to be made at international level towards a

globally harmonized approach to traceability and to establish a globally accepted unique device identification

(UDI) system for medical devices (see Annex A).

Fundamental to establishing an effective medical device traceability system harmonized at a European level is

implementation of UDI and the sharing of key information between stakeholders.

This document is a high level executive summary of traceability of medical devices. Its target audience is any

and all stakeholders participating in the medical device supply chain, from raw materials to the patient. It is not

intended to provide detailed information for full implementation of traceability systems.

The proposal from the European Commission for a regulation of the European Parliament and of the Council on medical devices and

amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 adopted on 26 September 2012, and

the proposal from the European Commission for a regulation of the European Parliament and of the Council on in vitro diagnostic medical

devices adopted on 26 September 2012.
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SIST-TP CEN/CLC/TR 14060:2015
CEN/CLC/TR 14060:2014 (E)
1 Scope

This Technical Report identifies key elements needed for a European system that would provide 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.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
traceability

ability to track forward the movement through specified stage(s) of the extended supply chain and trace

backward the history, application or location of that which is under consideration

[SOURCE: EN ISO 9001:2008]

Note 1 to entry: The term 'traceability’ as defined in 2013/172/EU is: the ability to trace the history, application or

location of that which is under consideration. The reason for not using the definition of 2013/172/EU for the purposes of

this document is that it only covers the 'trace' part of traceability and not the 'track’ part.

Note 2 to entry: The term 'traceability' defined by GS1 is: 'The ability to track forward the movement through specified

stage(s) of the extended supply chain and trace backward the history, application or location of that which is under

consideration'. GS1 is an international not-for-profit association dedicated to the design and implementation of global

standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors.

2.2
medical device

any instrument, apparatus, appliance, software, material or other article, whether used alone or in

combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or

therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for

human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

— investigation, replacement or modification of the anatomy or of a physiological process,

— control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its function by such means

[SOURCE: Directive 93/42/EEC]
2.3
active implantable medical device

any active medical device which is intended to be totally or partially introduced, surgically or medically, into the

human body or by medical intervention into a natural orifice, and which is intended to remain after the

procedure
[SOURCE: Direct
...

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