CEN/CLC/TR 14060:2014
(Main)Medical device traceability enabled by unique device identification (UDI)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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.
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: Directive 90/385/EEC]
2.4
in vitro diagnostic medical device
any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,
equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro
for the examination of specimens, including blood and tissue donations, derived from the human body, solely
or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures
Note 1 to entry: Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen
receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary
containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic
examination.
Note 2 to entry: Products for general laboratory use are not in vitro diagnostic medical devices unless such products,
in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic
examination.
[SOURCE: Directive 98/79/EC]
2.5
unique device identification (UDI)
data coding system that is created through an internationally accepted device identification and coding
standard and allows the unambiguous identification of specific medical devices on the market. The UDI
comprises the device identifier and production identifier
[SOURCE: Recommendation 2013/172/EU]
2.6
device identifier
unique identification specific to a manufacturer and a device model
[SOURCE: Recommendation 2013/172/EU]
2.7
production identifier
unique identification that identifies data related to the unit of device production
[SOURCE: Recommendation 2013/172/EU]
2.8
UDI carrier
way in which the unique device identification is conveyed by means of the Automatic Identification and Data
Capture (AIDC) and, if applicable, its human readable interpretation (HRI)
[SOURCE: Recommendation 2013/172/EU]
2.9
UDI electronic system
central repository/database storing device identifier codes and related/associated identifying information of
specific devices placed on the Union market
[SOURCE: Recommendation 2013/172/EU]
Note 1 to entry: There may be national databases that feed the central EU database.
2.10
human readable interpretation (HRI)
legible format of the data characters encoded in the AIDC symbol
[SOURCE: Recommendation 2013/172/EU]
2.11
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his own name, regardless of whether these operations are carried out
by that person himself or on his behalf by a third party
[SOURCE: Directive 93/42/EEC]
2.12
authorised representative
any natural or legal person established within the Union who, explicitly designated by the manufacturer, acts
and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to
the latter’s obligations under the relevant Community l
...
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