欧盟Eurlex法规详细信息

EURLEX ID:32012R0207

OJ编号:OJ L 72, 10.3.2012, p. 28-31

中文标题:委员会条例(EU) No 207/2012,医疗设备使用的电子说明(1)

原文标题:Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (1)

分类:15.20.20_消费者信息、教育与表现

文件类型:二级立法 Regulation|条例

生效日期:2013-03-01

废止日期:2058-12-31

法规全文:查看欧盟官方文件

L 72/28
EN
Official Journal of the European Union
10.3.2012
COMMISSION REGULATION (EU) No 207/2012
of 9 March 2012
on electronic instructions for use of medical devices
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
obligations laid down in this Regulation should be
reviewed by a notified body during the procedure
Having regard to the Treaty on the Functioning of the European
applicable for conformity assessment based on a
Union,
specific sampling method.
Having regard to Council Directive 90/385/EEC of 20 June
(8) As
the
protection
of
the
right
to
privacy
of
natural
1990 on the approximation of the laws of the Member States
persons with respect to the processing of personal data
relating to active implantable medical devices ( 1 ), and in
should be ensured by manufacturers and notified bodies
particular Article 9(10) thereof,
as well, it is appropriate to provide that websites
containing instructions for use of a medical device fulfil
Having regard to Council Directive 93/42/EEC of 14 June 1993
the requirements of Directive 95/46/EC of the European
concerning medical devices ( 2 ), and in particular Article 11(14)
Parliament and of the Council of 24 October 1995 on
thereof,
the protection of individuals with regard to the
processing of personal data and on the free movement
Whereas:
of such data ( 3 ).
(1) For
some
medical
devices
the
provision
of
instructions
for use in electronic form instead of in paper form can
(9) In
order
to
ensure
safety
and
consistency,
instructions
for
be beneficial for professional users. It can reduce the
use in electronic form which are provided in addition to
environmental burden and improve the competitiveness
complete instructions for use in paper form should be
of the medical devices industry by reducing costs, while
covered by this Regulation as regards limited
maintaining or improving the level of safety.
requirements in relation to their contents and websites.
(2) Such
possibility
of
providing
instructions
for
use
in
elec
(10) It
is
appropriate
to
provide
for
a
deferred
application
of
tronic form instead of in paper form should be limited to
this Regulation so as to facilitate the smooth transition to
certain medical devices and accessories intended to be
the new system and to allow all operators and Member
used in specific conditions. In any case, for reasons of
States time to adapt to it.
safety and efficiency users should always have the possi
bility to obtain those instructions for use in paper form
on request.
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Committee set up
(3)
In order to reduce potential risks as far as possible, the
by Article 6(2) of Directive 90/385/EEC,
appropriateness of the provision of instructions for use
in electronic form should be subject to a specific risk
HAS ADOPTED THIS REGULATION:
assessment by the manufacturer.
Article 1
(4) In order to ensure that users have access to the
instructions for use, appropriate information about
This Regulation establishes the conditions under which the
access to those instructions for use in electronic form
instructions for use of medical devices referred to in point 15
and about the right to request the instructions for use
of Annex 1 to Directive 90/385/EEC and in point 13 of Annex
in paper form, should be provided.
I to Directive 93/42/EEC may be provided in electronic form
instead of in paper form.
(5) To
ensure
unconditional
access
to
the
instructions
for
use
in electronic form and to facilitate the communication of
It also establishes certain requirements concerning instructions
updates and of product alerts, the instructions for use in
for use in electronic form which are provided in addition to
electronic form should also be available through a
complete instructions for use in paper form relating to their
website.
contents and websites.
(6) Regardless
of
the
language
obligations
imposed
on
manufacturers by the law of the Member States, manu
Article 2
facturers who provide instructions for use in electronic
For the purposes of this Regulation, the following definitions
form should indicate on their website in which Union
shall apply:
languages those instructions are available.
(7) Except
for
medical
devices
of
Class
I,
as
defined
in
Annex (a) ‘instructions for use’ means information provided by the
IX to Directive 93/42/EEC, the fulfilment of the
manufacturer to inform the user of the device of its safe
and proper use, of its expected performances and of any
( 1 ) OJ L 189, 20.7.1990, p. 17.
( 2 ) OJ L 169, 12.7.1993, p. 1.
( 3 ) OJ L 281, 23.11.1995, p. 31.

EN
10.3.2012 Official
Journal
of
the
European
Union L
72/29
precautions to be taken as outlined in the relevant parts of
Article 4
point 15 of Annex 1 to Directive 90/385/EEC and of point
13 of Annex I to Directive 93/42/EEC;
1. Manufacturers
of
devices
referred
to
in
Article
3
that
provide instructions for use in electronic form instead of in
paper form shall undertake a documented risk assessment
(b) ‘instructions for use in electronic form’ means instructions
which shall cover at least the following elements:
for use displayed in electronic form by the device, contained
in portable electronic storage media supplied by the manu
(a) knowledge and experience of the intended users in
facturer together with the device, or instructions for use
particular regarding the use of the device and user needs;
available through a website;
(b) characteristics of the environment in which the device will
(c) ‘professional users’ means persons using the medical device
be used;
in the course of their work and in the framework of a
professional healthcare activity;
(c) knowledge and experience of the intended user of the
hardware and software needed to display the instructions
(d) ‘fixed installed medical devices’ means devices and their
for use in electronic form;
accessories which are intended to be installed, fastened or
otherwise secured at a specific location in a healthcare
facility so that they cannot be moved from this location
(d) access of the user to the reasonably foreseeable electronic
or detached without using tools or apparatus, and which
resources needed at the time of use;
are not specifically intended to be used within a mobile
healthcare facility.
(e) performance of safeguards to ensure that the electronic data
and content are protected from tampering;
Article 3
1. Subject to the conditions set out in paragraph 2, manu
(f) safety and back-up mechanisms in the event of a hardware
facturers may provide instructions for use in electronic form
or software fault, particularly if the instructions for use in
instead of in paper form where those instructions relate to
electronic form are integrated within the device;
any of the following devices:
(g) foreseeable medical emergency situations requiring the
(a) active implantable medical devices and their accessories
provision of information in paper form;
covered by Directive 90/385/EEC intended to be used
exclusively for the implantation or programming of a
(h) impact caused by the temporary unavailability of the
defined active implantable medical device;
specific website or of the Internet in general, or of their
access in the healthcare facility as well as the safety
measures available to cope with such a situation;
(b) implantable medical devices and their accessories covered by
Directive 93/42/EEC intended to be used exclusively for the
implantation of a defined implantable medical device;
(i) evaluation of the time period within which the instructions
for use shall be provided in paper form at the users request.
(c) fixed installed medical devices covered by Directive
93/42/EEC;
2. The risk assessment for the provision of the instructions
for use in electronic form shall be updated in view of the
experience gained in the post-marketing phase.
(d) medical devices and their accessories covered by Directives
90/385/EEC and 93/42/EEC fitted with a built-in system
visually displaying the instructions for use;
Article 5
Manufacturers of devices referred to in Article 3 may provide
instructions for use in electronic form instead of in paper form
(e) stand-alone software covered by Directive 93/42/EEC.
under the following conditions:
2. Manufacturers
may
provide
instructions
for
use
in
elec
(1) the risk assessment referred to in Article 4 shall demon
tronic form instead of in paper form for the devices listed in
strate that providing instructions for use in electronic form
paragraph 1 under the following conditions:
maintains or improves the level of safety obtained by
providing the instructions for use in paper form;
(a) the devices and accessories are intended for exclusive use by
professional users;
(2) they shall provide instructions for use in electronic form in
all Member States where the product is made available or
put into service, unless duly justified in the risk assessment
(b) the use by other persons is not reasonably foreseeable.
referred to in Article 4;

L 72/30
EN
Official Journal of the European Union
10.3.2012
(3) they shall have a system in place to provide the
That information shall be provided as set out in the second
instructions for use in printed paper form at no additional
subparagraph of paragraph 1 or, if not practicable, in a paper
cost for the user, within the time period set out in the risk
document supplied with each device.
assessment referred to in Article 4 and at the latest within
7 calendar days of receiving a request from the user or at
the time of delivery of the device if so requested at the
3. The
information
on
how
to
access
the
instructions
for
use
time of order;
in electronic form shall contain the following:
(4) they shall provide, on the device or on a leaflet,
(a) any information needed to view the instructions for use;
information on foreseeable medical emergency situations
and, for devices fitted with a built-in system visually
displaying the instructions for use, information on how
(b) a unique reference, giving direct access, and any other
to start the device;
information needed by the user to identify and access the
appropriate instructions for use;
(5) they shall ensure the proper design and functioning of the
instructions for use in electronic form and provide verifi
(c) relevant manufacturer contact details;
cation and validation evidence to this effect;
(d) where, how and within which time instructions for use in
(6) for medical devices fitted with a built-in system visually
paper form can be requested and shall be obtained at no
displaying the instructions for use, they shall ensure that
additional cost in conformity with Article 5.
displaying the instructions for use does not impede the
safe use of the device, in particular life-monitoring or
4. Where a part of the instructions for use is intended to be
life-supporting functions;
provided to the patient, that part shall not be provided in
electronic form.
(7) they shall provide, in their catalogue or in other appro
priate device information support, information on software
5. The
instructions
for
use
in
electronic
form
shall
be
and hardware requirements needed to display the
available entirely as text which may contain symbols and
instructions for use;
graphics with at least the same information as the instructions
for use in paper form. Video or audio files may be offered in
(8) they shall have a system in place to clearly indicate when
addition to the text.
the instructions for use have been revised and to inform
each user of the device thereof if the revision was
Article 7
necessary for safety reasons;
1. Where
manufacturers
provide
the
instructions
for
use
in
electronic form on an electronic storage medium together with
(9) for devices with a defined expiry date, except implantable
the device or where the device itself is fitted with a built-in
devices, they shall keep the instructions for use available
system visually displaying the instructions for use, the
for the users in electronic form for at least 2 years after
instructions for use in electronic form shall also be made
the end of the expiry date of the last produced device;
accessible to the users through a website.
(10) for devices without a defined expiry date and for
2. Any
website
containing
instructions
for
use
of
a
device
implantable devices, they shall keep the instructions for
which are provided in electronic form instead of in paper form
use available for the users in electronic form for a
shall comply with the following requirements:
period of 15 years after the last device has been manu
factured.
(a) the instructions for use shall be provided in a commonly
used format that can be read with freely available software;
Article 6
1. Manufacturers
shall
clearly
indicate
that
the
instructions (b) it shall be protected against hardware and software
for use of the device are supplied in electronic form instead
intrusion;
of in paper form.
(c) it shall be provided in such a way that the server downtime
That information shall be provided on the packaging for each
and display errors are reduced as far as possible;
unit or, where appropriate, on the sales packaging. In the case
of fixed installed medical devices, that information shall also be
provided on the device itself.
(d) it shall mention in which Union languages the manufacturer
provides the instructions for use in electronic form;
2. Manufacturers
shall
provide
information
on
how
to
access
the instructions for use in electronic form.
(e) it shall fulfil the requirements of Directive 95/46/EC;

EN
10.3.2012 Official
Journal
of
the
European
Union L
72/31
(f) the Internet address as displayed in accordance with
Article 9
Article 6(2) shall be stable and directly accessible during
the periods set out in points (9) and (10) of Article 5;
Instructions for use in electronic form which are provided in
addition to complete instructions for use in paper form shall be
consistent with the content of the instructions for use in paper
(g) all previous versions of the instructions for use issued in
form.
electronic form and their date of publication shall be
available on the website.
Where such instructions for use are provided through a website,
this website shall fulfil the requirements set out in points (b), (e)
Article 8
and (g) of paragraph 2 of Article 7.
Except for medical devices of Class I, as defined in Annex IX to
Directive 93/42/EEC, the fulfilment of the obligations laid down
in Articles 4 to 7 of this Regulation shall be reviewed by a
Article 10
notified body during the procedure applicable for conformity
This Regulation shall enter into force on the 20th day following
assessment as referred to in Article 9 of Directive 90/385/EEC
its publication in the Official Journal of the European Union.
or Article 11 of Directive 93/42/EEC. The review shall be based
on a specific sampling method adapted to the class and the
complexity of the product.
It shall apply from 1 March 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 March 2012.
For the Commission
The President
José Manuel BARROSO

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