欧盟Eurlex法规详细信息

EURLEX ID:32013H0172

OJ编号:OJ L 99, 9.4.2013, p. 17-24

中文标题:委员会建议2013/172/EU,关于欧盟医疗器械唯一设备识别系统的共同框架(1)

原文标题:2013/172/EU: Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union Text with EEA relevance

分类:13.30.99_统一法的其它部分

文件类型:二级立法 Recommendation|建议

生效日期:2013-04-05

废止日期:2058-12-31

法规全文:查看欧盟官方文件

EN
9.4.2013 Official
Journal
of
the
European
Union L
99/17
RECOMMENDATIONS
COMMISSION RECOMMENDATION
of 5 April 2013
on a common framework for a unique device identification system of medical devices in the Union
(Text with EEA relevance)
(2013/172/EU)
THE EUROPEAN COMMISSION,
(5) Significant
efforts
are
being
made
at
international
level
towards a globally harmonised approach on traceability
and to establish a globally accepted unique device identi
fication (UDI) system for medical devices.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 292 thereof,
(6) UDI
mechanisms,
based
on
different
national
and/or
Whereas:
regional traceability requirements, have already been
developed and there is a risk that further diverging UDI
mechanisms may be developed at these levels.
(1) Traceability
of
medical
devices
throughout
the
whole
supply chain contributes to patient safety by facilitating
vigilance, market surveillance and transparency in this
(7) In
future
certain
information
contained
in
the
UDI
code
sector.
could feed the Electronic Health Record according to
Directive 2011/24/EU of the European Parliament and
of the Council of 9 March 2011 on the application of
patients’ rights in cross-border healthcare ( 4 ) and the
(2) The
current
regulatory
framework
for
medical
devices
Digital Agenda for Europe ( 5 ),
does not include specific provisions on traceability.
Therefore, a recommendation paving the way to a
reinforced regulatory approach on traceability of
medical devices is needed.
HAS ADOPTED THIS RECOMMENDATION:
(3) The
proposal
from
the
European
Commission
for
a
regu
lation of the European Parliament and of the Council on
medical devices, and amending Directive 2001/83/EC,
1. INTRODUCTION
Regulation (EC) No 178/2002 and Regulation (EC) No
Purpose of the Recommendation
1223/2009 ( 1 ) adopted on 26 September 2012, and the
proposal from the European Commission for a regulation
1. Traceability is currently not regulated by the medical device
of the European Parliament and of the Council on in vitro
directives ( 6 ) while it is addressed in some cases at national
diagnostic medical devices ( 2 ) adopted on 26 September
and/or regional level. The differences and incompatibility
2012, include provisions on traceability of medical
between the traceability mechanisms may weaken and
devices and in vitro diagnostic medical devices, in order
compromise the efficiency of the systems put in place.
to improve patient health and safety.
2. In addition, the development of different national and/or
(4) The
Council
conclusions
on
innovation
in
the
medical
regional unique device identification mechanisms would
device sector ( 3 ) of 6 June 2011 invites the Commission
oblige manufacturers to adapt their products to each
and Member States to pay particular attention to inter
mechanism in order to fulfil traceability obligations.
operability and safety issues related to the integration of
medical devices in e-Health systems, especially personal
health systems.
( 4 ) OJ L 88, 4.4.2011, p. 45.
( 5 ) http://ec.europa.eu/digital-agenda/
( 6 ) Council Directive 90/385/EEC (OJ L 189, 20.7.1990, p. 17), Council
( 1 ) COM(2012) 542 final
Directive 93/42/EEC (OJ L 169, 12.7.1993, p. 1), Directive
( 2 ) COM(2012) 541 final.
98/79/EC of the European Parliament and of the Council (OJ
( 3 ) OJ C 202, 8.7.2011, p. 7.
L 331, 7.12.1998, p. 1).

L 99/18
EN
Official Journal of the European Union
9.4.2013
3. The best way to ensure effective traceability of medical
out under the auspice of the International Medical Device
devices in the Union is to develop a UDI system
Regulators Forum (IMDRF) ( 3 ).
harmonised at European level. The ongoing revision
process of the current Directives on medical devices
10. This Recommendation is aligned to the approach developed
should empower the Commission to adopt detailed tracea
at international level.
bility requirements.
European activity on UDI
11. In 2010, the European Commission set up a European UDI
4. In the meantime, should Member States decide to develop
ad hoc Working Group, within the regulatory framework
their own UDI mechanisms it is essential that these are
established by the directives on medical devices, in order to
made compatible with each other and with the future
UDI system of the Union. This is important in order to
develop a coordinated approach, taking into account the
avoid the risk of incompatible and divergent systems frus
progress made at both national and international level.
trating the objectives of the internal market and to facilitate
the introduction of a harmonized UDI system of the Union.
12. The aim of the group is threefold:
(a) first, it is intended to encourage contributions and
monitor the reaction of Competent Authorities to the
5. This Recommendation does not aim to define all the
work carried out at international level;
aspects of the UDI system. It should be taken as a tool
to facilitate the compatibility of the traceability mechanisms
established at national and/or regional level and to pave the
(b) second, it encourages the sharing of views and
way to the mandatory implementation of an internationally
information on national initiatives developed by
compatible UDI system of the Union.
Member States and search for common solutions;
(c) thirdly, it facilitates the convergence with the future
Union legislation of national initiatives developed by
Scope of the Recommendation
Member States.
6. This Recommendation applies to medical devices, active
implantable medical devices (other than devices which are
2. RATIONALE
custom-made or intended for clinical investigations) and in
vitro diagnostic medical devices (other than those manu
13. The primary objectives of a UDI system are patient
factured in health institutions and for performance evalu
safety ( 4 ) enhancement and patient care optimisation. It
ation), including their accessories.
pursues these objectives by:
(a) improving incident reporting;
International activity on UDI
(b) facilitating efficient recalls and other field safety
7. At international level, in 2008 the Global Harmonization
corrective actions (FSCA);
Task Force (GHTF) ( 1 ) set up an ad hoc working group with
the purpose of developing an internationally coordinated
(c) facilitating efficient post market actions by national
approach on UDI.
competent authorities;
(d) enabling queries in numerous data systems;
8. This group, gathering industry and regulators, was chaired
by the European Commission and ceased its activity in
(e) reducing the likelihood of medical errors linked to
September 2011, when the GHTF adopted a guidance ( 2 )
misuse of the device.
document on a ‘Unique Device Identification (UDI) System
for Medical Devices’.
( 3 ) The ‘International Medical Device Regulators Forum (IMDRF)’ was
conceived in February 2011 as a forum to discuss future directions
in medical device regulatory harmonisation. It is a voluntary group
of medical device regulators from Australia, Brazil, Canada, China
9. The work of the GHTF towards a further harmonisation of
(observer), European Union, Japan, Russia (observer) and the United
the medical device regulatory framework is being carried
States who have come together to build on the strong foundational
work of the ‘Global Harmonization Task Force on Medical Devices
(GHTF)’. The ‘World Health Organization (WHO)’ participates in the
( 1 ) The ‘Global Harmonization Task Force (GHTF)’ is a voluntary inter
IMDRF as an observer.
national group of representatives from medical device regulatory
( 4 ) Patient safety is understood as the avoidance, prevention and ameli
authorities and trade associations from Europe, the United States
oration of adverse outcomes or injuries stemming from the
of America (USA), Canada, Japan and Australia. GHTF was
processes of health care. These events include ‘errors’, ‘deviations’,
conceived in 1992 in an effort to respond to the growing need
‘accidents’. Safety emerges from the interaction of the components
for international harmonisation in the regulation of medical
of the system; it does not reside in a person, device or department.
devices. The GHTF mission ended in December 2012.
Improving safety depends on learning how safety emerges from the
( 2 ) www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/
interactions of the components. Patient safety is a subset of health
ghtf-sc-n2r3-2011-unique-device-identification-system-110916.pdf
care quality.

EN
9.4.2013 Official
Journal
of
the
European
Union L
99/19
14. The establishment of a UDI system could also support the
3. DEFINITIONS
achievement of other objectives such as the fight against
counterfeiting, better distribution control, stock
For the purposes of this Recommendation the following
management and reimbursement issues.
definitions apply:
(a) ‘medical device’ means any instrument, apparatus,
15. However, the objectives referred to in paragraph 14 should
appliance, software, material or other article, whether
be seen as possible positive consequences of the UDI
used alone or in combination, including the software
system.
intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary
for its proper application, intended by the manu
Improvement of incident reporting
facturer to be used for human beings for the
purpose of:
16. The use of a UDI is expected to improve incident reporting
and offers the opportunity to gather all the incidents related
to one medical device at Union level and, in case of an
— diagnosis, prevention, monitoring, treatment or
internationally accepted and compatible UDI, at inter
alleviation of disease,
national level. This will increase the potential for
comparing results associated with each specific medical
device.
— diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
Efficient recalls and other field safety corrective actions
— investigation, replacement or modification of the
17. The attribution of a unique identifier to a specific device
anatomy or of a physiological process,
and its use along the distribution chain (global use) will
allow the unambiguous identification of the device itself.
— control of conception,
18. For traceability to be ensured, it is not sufficient that every
and which does not achieve its principal intended
manufacturer has developed its own traceability mech
action in or on the human body by pharmacological,
anism. The lack of a Union system used all along the
immunological or metabolic means, but which may be
supply chain could lead to negative outcomes inasmuch
assisted in its function by such means ( 1 );
as each actor of the distribution chain might modify the
coding developed by the manufacturer. This might give rise
(b) ‘active implantable medical device’ means any active
to errors in the encoding of medical devices which would
medical device which is intended to be totally or
in turn endanger the traceability of devices in case of FSCA.
partially introduced, surgically or medically, into the
The use of the same coding language improves the tracking
human body or by medical intervention into a
and tracing of medical devices.
natural orifice, and which is intended to remain after
the procedure ( 2 );
Efficient post market actions by national competent authorities
(c) ‘in vitro diagnostic medical device’ means any medical
19. A UDI system helps specifically to target identified
device which is a reagent, reagent product, calibrator,
products.
control material, kit, instrument, apparatus, equipment
or system, whether used alone or in combination,
intended by the manufacturer to be used in vitro for
20. In addition, it will provide an opportunity to ensure coor
the examination of specimens, including blood and
dinated reactions by Member States.
tissue donations, derived from the human body,
solely or principally for the purpose of providing
information:
Queries in numerous data systems
21. By using the same UDI in different data systems (both at
— concerning a physiological or pathological state, or
regulatory and health institutions level) queries will become
more efficient and it will be easier to perform searches in
— concerning a congenital abnormality, or
order to aggregate information. At the moment, this
approach is not possible because each data system has its
own identification tool.
— to determine the safety and compatibility with
potential recipients, or
Reduction of medical errors
— to monitor therapeutic measures.
22. It might be expected that, by using identification mech
anisms, the number of cases where medical devices have
( 1 ) Article 1(2)(a) of Directive 93/42/EEC.
been incorrectly selected will be reduced.
( 2 ) Article 1(2)(c) of Directive 90/385/EEC.

L 99/20
EN
Official Journal of the European Union
9.4.2013
Specimen receptacles are considered to be in vitro diag
(e.g. producing two different surface conditions by
nostic medical devices. ‘Specimen receptacles’ are those
laser etching, moulding, peening or other technologies
devices, whether vacuum-type or not, specifically
like ink jet printing or flexography);
intended by their manufacturers for the primary
containment and preservation of specimens derived
from the human body for the purpose of in vitro diag
(l) ‘manufacturer’
means
the
natural
or
legal
person
with
nostic examination.
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
Products for general laboratory use are not in vitro
these operations are carried out by that person
diagnostic medical devices unless such products, in
himself or on his behalf by a third party ( 3 );
view of their characteristics, are specifically intended
by their manufacturer to be used for in vitro diag
(m) ‘authorised representative’ means any natural or legal
nostic examination ( 1 );
person established within the Union who, explicitly
designated by the manufacturer, acts and may be
addressed by authorities and bodies in the
(d) ‘traceability’ means the ability to trace the history,
Community instead of the manufacturer with regard
application or location of that which is under
to the latter’s obligations under the relevant
consideration;
Community legislation ( 4 );
(n) ‘importer’ means any natural or legal person estab
(e) ‘unique device identification — UDI’ means a series of
lished within the Union who places a device from a
numeric or alphanumeric characters that is created
third country on the Union market (
through an internationally accepted device identifi

5 );
cation and coding standard and allows the
unambiguous identification of specific medical
(o) ‘distributor’ means any natural or legal person in the
devices on the market. The UDI comprises the device
supply chain, other than the manufacturer or the
identifier and production identifier;
importer, who makes a device available on the
market ( 6 );
(f) ‘device identifier’ means a unique numeric or alpha
numeric code specific to a manufacturer and a
(p) ‘economic operators’ means the manufacturer, the
device model;
authorised representative, the importer and the
distributor ( 7 );
(g) ‘production identifier’ means a unique numeric or
(q) ‘health institution’ means an organisation whose
alphanumeric code that identifies data related to the
primary purpose is the care or treatment of patients
unit of device production;
and/or the promotion of public health;
(h) ‘UDI carrier’ means the way in which the unique
(r) ‘user’
means
the
person,
either
professional
or
lay,
who
device identification is conveyed by means of the
uses a device.
Automatic Identification and Data Capture ( 2 ) (AIDC)
and, if applicable, its human readable interpretation
4.
(HRI);
RISK BASED APPROACH
23. Should Member States intend to establish a UDI system
they should follow a risk based approach in accordance
(i) ‘UDI
electronic
system’
means
a
central
repository/da
with the classification of the device.
tabase storing device identifier codes and related/as
sociated identifying information of specific devices
placed on the Union market;
24. The UDI system should be implemented gradually, starting
from highest risk class devices which should be the first to
respect the condition to bear the UDI.
(j) ‘human
readable
interpretation’
means
a
legible
format
of the data characters encoded in the AIDC symbol;
UDI type
25. The UDI should comprise two parts, a device identifier and
a production identifier.
(k) ‘direct part mark’ means any technology which can be
used to fix a symbol on the surface of an item
( 3 ) Article 1(2)(f) of Directive 93/42/EEC.
( 4 ) Article 1(2)(j) of Directive 93/42/EEC.
( 1 ) Article 1(2)(b) of Directive 98/79/EC.
( 5 ) Article 2(5) of Regulation (EC) No 765/2008 of the European
( 2 ) The Automatic Identification and Data Capture refers to the methods
Parliament and of the Council (OJ L 218, 13.8.2008, p.30).
for automatically identifying objects, collecting data about them, and
( 6 ) Article 2(6) of Regulation (EC) No 765/2008.
entering the data directly into computer systems.
( 7 ) Article 2(7) of Regulation (EC) No 765/2008.

EN
9.4.2013 Official
Journal
of
the
European
Union L
99/21
26. The device identifier should contain static information ( 1 )
UDI application
specific to a manufacturer and a device model and is also
used as the ‘access key’ to information stored in a UDI
33. As a general rule, UDI should be applied to every
database.
packaging level for all classes of devices ( 5 ).
34. UDI carrier (AIDC and HRI representation of the UDI)
27. The production identifier should contain dynamic
should be on the label of the device, its package, or on
information ( 2 ) identifying data related to the unit of
the device itself (direct part mark), and on all higher levels
device production and determine the level of traceability
of packaging ( 6 ).
to be achieved.
5. CONDITIONS TO BE FULFILLED BY ECONOMIC OPER
28. UDI should appear in both human readable format (human
ATORS, HEALTH INSTITUTIONS AND PROFESSIONAL
readable version composed of a series of numeric or alpha
USERS
numeric characters) and in a format that can be read by an
35. In order to achieve the objectives of the UDI system, while
AIDC technology and conveyed via a carrier.
developing their own national UDI mechanisms, the
economic operators and health institutions should store
through the distribution chain information related to
29. If there are significant constraints limiting the use of both
both the device identifier (static information) and the
AIDC and HRI on the label, the AIDC format should be
production identifier (dynamic information). Health insti
favoured. However, certain environments or use situations,
tutions and, where feasible, professional users should use
such as home care, may warrant the use of HRI over AIDC.
this information in their reporting of incidents. This will, in
particular, allow a more efficient action in case of recall or
withdrawal of products.
30. Member States should monitor that differentiation between
the different classes of devices is based exclusively on the
36. Information related to the device identifier (static
type of production identifier (dynamic information) in
information) should be collected into the national UDI
accordance with paragraph 31.
databases.
31. As a general rule, the information provided by the
37. Once the future European databank on medical devices
production identifier (dynamic information) should vary
(Eudamed) is established, information related to device
according to the different risk classes as follows (
identifier (static information) will be centralised at

3 ):
European level via a European UDI electronic system
which will be part of the future Eudamed.
— expiration date and/or manufacturing date for class I,
38. As regards information related to production identifier
(dynamic information), it should not be sent to the
national UDI databases and will not be included in the
— lot/batch number for class IIa,
European UDI electronic system.
— lot/batch number for class IIb,
For the purpose of this Recommendation economic oper
ators, health institutions and professional users should align
with the following conditions.
— lot/batch number or serial number ( 4 ) for class III.
Manufacturers
39. First, manufacturers should appropriately allocate a UDI
32. Where appropriate, manufacturers may choose a
(static and dynamic parts) to the medical devices they
production identifier (dynamic information) applicable to
manufacture.
a higher class than the device in question.
( 1 ) This information does not vary from one to another device of the
40. Second, they should provide the required data elements (see
same specific model.
Annex) to be included in the UDI database.
( 2 ) This information varies according to the different way the
production process is controlled (by expiration/manufacturing date,
lot/batch number or serial number).
( 5 ) In accordance with international guidance, possible exceptions
( 3 ) In accordance with international guidance, possible exceptions
and/or exemptions to the general rule, based on the device class,
and/or exemptions to the general rule, based on the device class,
should be taken into account.
should be taken into account.
( 6 ) According to international guidance, pallets are not included in the
( 4 ) The serial number allows the identification of the individual device
notion of higher levels of packaging therefore UDI conditions do not
unit.
apply to pallets.

L 99/22
EN
Official Journal of the European Union
9.4.2013
41. Third, they should modify the labelling of their products in
business in a Member State, he should designate a single
order to print the UDI code as far as practicable on the
authorised representative in the Union. The designation
label of the device, its package, or on the device itself
must be effective at least for all devices of the same model.
(direct part mark), and on all higher levels of packaging,
as referred to in paragraph 34.
53. The authorised representatives should have access, on
42. Fourth, they should keep an electronic record of both
request, to the record of both device identifier (static
device identifier (static information) and production
information) and production identifier (dynamic
identifier (dynamic information).
information) related to the product(s) for which he is
appointed.
43. Lastly, they should keep an electronic record of the
economic operator, health institution or professional
users to whom they have supplied each specific product.
Distributors
54. First, before making a device available on the market
distributors should verify that the manufacturer and,
Importers
where applicable, the importer has appropriately allocated
44. First, importers should verify that the manufacturer has
a UDI (static and dynamic parts) to the product. Where a
appropriately allocated a UDI (static and dynamic parts)
distributor considers or has reason to believe that this
to the product before they put it on the Union market.
condition has not been fulfilled, he should not make the
Where an importer considers or has reason to believe that
device available on the Union market until it is brought
this condition has not been fulfilled, he should not place
into conformity.
the device on the Union market until it is brought into
conformity.
55. Second, distributors should not remove or modify the UDI,
otherwise traceability will be impossible.
45. Second, importers should not remove or modify the UDI,
otherwise traceability will be impossible.
56. Third, they should keep an electronic record of both device
46. Third, they should ascertain whether the device has already
identifier (static information) and production identifier
been registered in the UDI database of the Member State
(dynamic information).
where the device has been placed on the Union market.
47. If the device has already been registered, importers should
57. Fourth, they should keep an electronic record of the
verify that the device identifier (static information) on the
economic operator who has supplied them with a device.
product corresponds to that in the UDI database.
48. If the device has not yet been registered, the importers
58. Lastly, they should keep an electronic record of the
should align with the conditions concerning the regis
economic operator, health institution or professional
tration of the information related to the device identifier
users to whom they have supplied a device.
(static information).
Health institutions
49. Fourth, they should keep an electronic record of both
device identifier (static information) and production
59. First, health institutions should keep an electronic record of
identifier (dynamic information).
both device identifier (static information) and production
identifier (dynamic information) of medical devices entering
these organisations. Information related to both device
50. Fifth, they should keep an electronic record of the
identifier (static information) and production identifier
economic operator who has supplied them with a device.
(dynamic information) in respect of devices for which
incidents are reported should be used by health institutions
in their reporting of incidents.
51. Lastly, they should keep electronic record of the economic
operator, health institution or professional users to whom
they have supplied the device.
60. Second, for certain medical devices, such as those used for
high risk procedures and/or specifically intended to be used
Authorised representatives
for high risk patients, a link should be established between
the device used and the patient treated with it. Therefore,
52. Where a manufacturer who places a device on the market
health institutions should keep a record of which device
under his own name does not have a registered place of
has been used on which patient.

EN
9.4.2013 Official
Journal
of
the
European
Union L
99/23
61. Third, for certain devices such as implantable medical
64. For the purpose of this Recommendation, Member States
devices, health institutions should store both device
are invited to promote the use of the Extensible Markup
identifier (static information) and production identifier
Language (XML), as a common format for data exchange
(dynamic information) in the electronic patient record.
between UDI databases, and take into account relevant
Indeed, in case of recall, it should be possible to know
specifications and semantic standards existing in the area.
exactly which medical device has been implanted to
which patient.
65. The data elements, which are listed in the Annex, should be
Professional users
introduced in UDI national databases and should
correspond to the elements linked to the device identifier
62. Where feasible, information related to both device identifier
(static information).
(static information) and production identifier (dynamic
information) in respect of devices for which incidents are
reported should be used by professional users in their
reporting of incidents.
Done at Brussels, 5 April 2013.
6. UDI NATIONAL DATABASES
Data elements
For the Commission
63. Member States who intend to establish a UDI system for
medical devices are invited to build it on national UDI
Tonio BORG
databases.
Member of the Commission

L 99/24
EN
Official Journal of the European Union
9.4.2013
ANNEX
DATA ELEMENTS OF THE NATIONAL UDI DATABASES
National databases on UDI should include the following data elements:
(a) quantity per package configuration;
(b) if applicable, alternative or additional identifier(s);
(c) the way how the device production is controlled (expiration date or manufacturing date, lot or batch number,
serialisation number);
(d) if applicable, the unit of use device identifier (when a UDI is not assigned to the device at the level of its unit of use,
a ‘unit of use’ device identifier shall be assigned to associate the use of a device with a patient);
(e) name and address of the manufacturer (as indicated on the label);
(f) if applicable, name and address of the authorised representative (as indicated on the label);
(g) Global Medical Device Nomenclature (GMDN) code or internationally recognised nomenclature code;
(h) if applicable, trade/brand name;
(i) if
applicable,
device
model,
reference,
or
catalogue
number;
(j) if
applicable,
clinical
size
(including
volume,
length,
gauge
and
diameter);
(k) additional product description (optional);
(l) if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use);
(m) if applicable, additional trade names of the device;
(n) labelled as single use device (y/n);
(o) if applicable, restricted number of reuses;
(p) device packaged sterile (y/n);
(q) need for sterilisation before use (y/n);
(r) labelled as containing latex (y/n);
(s) labelled as containing DEPH (y/n);
(t) URL for additional information, e.g. electronic instructions for use (optional);
(u) if applicable, critical warnings or contraindications.

Document Outline


附件:

P020171219348088884787.pdf

触碰右侧展开