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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to 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 (  1 ), and in 
particular Article 9(10) thereof,  
Having regard to Council Directive 93/42/EEC of 14 June 1993 
concerning medical devices (  2 ), and in particular Article 11(14) 
thereof,  
Whereas:  
(1) For some medical devices the provision of instructions 
for use in electronic form instead of in paper form can 
be beneficial for professional users. It can reduce the 
environmental burden and improve the competitiveness 
of the medical devices industry by reducing costs, while 
maintaining or improving the level of safety.  
(2) Such possibility of providing instructions for use in elec ­
tronic form instead of in paper form should be limited to 
certain medical devices and accessories intended to be 
used in specific conditions. In any case, for reasons of 
safety and efficiency users should always have the possi ­
bility to obtain those instructions for use in paper form 
on request.  
(3) In order to reduce potential risks as far as possible, the 
appropriateness of the provision of instructions for use 
in electronic form should be subject to a specific risk 
assessment by the manufacturer.  
(4) In order to ensure that users have access to the 
instructions for use, appropriate information about 
access to those instructions for use in electronic form 
and about the right to request the instructions for use 
in paper form, should be provided.  
(5) To ensure unconditional access to the instructions for use 
in electronic form and to facilitate the communication of 
updates and of product alerts, the instructions for use in 
electronic form should also be available through a 
website.  
(6) Regardless of the language obligations imposed on 
manufacturers by the law of the Member States, manu ­
facturers who provide instructions for use in electronic 
form should indicate on their website in which Union 
languages those instructions are available.  
(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 this Regulation should be 
reviewed by a notified body during the procedure 
applicable for conformity assessment based on a 
specific sampling method.  
(8) As the protection of the right to privacy of natural 
persons with respect to the processing of personal data 
should be ensured by manufacturers and notified bodies 
as well, it is appropriate to provide that websites 
containing instructions for use of a medical device fulfil 
the requirements of Directive 95/46/EC of the European 
Parliament and of the Council of 24 October 1995 on 
the protection of individuals with regard to the 
processing of personal data and on the free movement 
of such data (  3 ). 
(9) In order to ensure safety and consistency, instructions for 
use in electronic form which are provided in addition to 
complete instructions for use in paper form should be 
covered by this Regulation as regards limited 
requirements in relation to their contents and websites.  
(10) It is appropriate to provide for a deferred application of 
this Regulation so as to facilitate the smooth transition to 
the new system and to allow all operators and Member 
States time to adapt to it.  
(11) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee set up 
by Article 6(2) of Directive 90/385/EEC,  
HAS ADOPTED THIS REGULATION:  
Article 1  
This Regulation establishes the conditions under which the 
instructions for use of medical devices referred to in point 15 
of Annex 1 to Directive 90/385/EEC and in point 13 of Annex 
I to Directive 93/42/EEC may be provided in electronic form 
instead of in paper form.  
It also establishes certain requirements concerning instructions 
for use in electronic form which are provided in addition to 
complete instructions for use in paper form relating to their 
contents and websites.  
Article 2  
For the purposes of this Regulation, the following definitions 
shall apply:  
(a) ‘instructions for use’ means information provided by the 
manufacturer to inform the user of the device of its safe 
and proper use, of its expected performances and of anyEN L 72/28 Official Journal of the European Union 10.3.2012  
( 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.precautions to be taken as outlined in the relevant parts of 
point 15 of Annex 1 to Directive 90/385/EEC and of point 
13 of Annex I to Directive 93/42/EEC;  
(b) ‘instructions for use in electronic form’ means instructions 
for use displayed in electronic form by the device, contained 
in portable electronic storage media supplied by the manu ­
facturer together with the device, or instructions for use 
available through a website;  
(c) ‘professional users’ means persons using the medical device 
in the course of their work and in the framework of a 
professional healthcare activity;  
(d) ‘fixed installed medical devices’ means devices and their 
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 
or detached without using tools or apparatus, and which 
are not specifically intended to be used within a mobile 
healthcare facility.  
Article 3  
1. Subject to the conditions set out in paragraph 2, manu ­
facturers may provide instructions for use in electronic form 
instead of in paper form where those instructions relate to 
any of the following devices:  
(a) active implantable medical devices and their accessories 
covered by Directive 90/385/EEC intended to be used 
exclusively for the implantation or programming of a 
defined active implantable medical device;  
(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;  
(c) fixed installed medical devices covered by Directive 
93/42/EEC;  
(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;  
(e) stand-alone software covered by Directive 93/42/EEC.  
2. Manufacturers may provide instructions for use in elec ­
tronic form instead of in paper form for the devices listed in 
paragraph 1 under the following conditions:  
(a) the devices and accessories are intended for exclusive use by 
professional users;  
(b) the use by other persons is not reasonably foreseeable.  Article 4  
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 
which shall cover at least the following elements:  
(a) knowledge and experience of the intended users in 
particular regarding the use of the device and user needs;  
(b) characteristics of the environment in which the device will 
be used;  
(c) knowledge and experience of the intended user of the 
hardware and software needed to display the instructions 
for use in electronic form;  
(d) access of the user to the reasonably foreseeable electronic 
resources needed at the time of use;  
(e) performance of safeguards to ensure that the electronic data 
and content are protected from tampering;  
(f) safety and back-up mechanisms in the event of a hardware 
or software fault, particularly if the instructions for use in 
electronic form are integrated within the device;  
(g) foreseeable medical emergency situations requiring the 
provision of information in paper form;  
(h) impact caused by the temporary unavailability of the 
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;  
(i) evaluation of the time period within which the instructions 
for use shall be provided in paper form at the users request.  
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.  
Article 5  
Manufacturers of devices referred to in Article 3 may provide 
instructions for use in electronic form instead of in paper form 
under the following conditions:  
(1) the risk assessment referred to in Article 4 shall demon ­
strate that providing instructions for use in electronic form 
maintains or improves the level of safety obtained by 
providing the instructions for use in paper form;  
(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 
referred to in Article 4;EN 10.3.2012 Official Journal of the European Union L 72/29(3) they shall have a system in place to provide the 
instructions for use in printed paper form at no additional 
cost for the user, within the time period set out in the risk 
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 
time of order;  
(4) they shall provide, on the device or on a leaflet, 
information on foreseeable medical emergency situations 
and, for devices fitted with a built-in system visually 
displaying the instructions for use, information on how 
to start the device;  
(5) they shall ensure the proper design and functioning of the 
instructions for use in electronic form and provide verifi ­
cation and validation evidence to this effect;  
(6) for medical devices fitted with a built-in system visually 
displaying the instructions for use, they shall ensure that 
displaying the instructions for use does not impede the 
safe use of the device, in particular life-monitoring or 
life-supporting functions;  
(7) they shall provide, in their catalogue or in other appro ­
priate device information support, information on software 
and hardware requirements needed to display the 
instructions for use;  
(8) they shall have a system in place to clearly indicate when 
the instructions for use have been revised and to inform 
each user of the device thereof if the revision was 
necessary for safety reasons;  
(9) for devices with a defined expiry date, except implantable 
devices, they shall keep the instructions for use available 
for the users in electronic form for at least 2 years after 
the end of the expiry date of the last produced device;  
(10) for devices without a defined expiry date and for 
implantable devices, they shall keep the instructions for 
use available for the users in electronic form for a 
period of 15 years after the last device has been manu ­
factured.  
Article 6  
1. Manufacturers shall clearly indicate that the instructions 
for use of the device are supplied in electronic form instead 
of in paper form.  
That information shall be provided on the packaging for each 
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.  
2. Manufacturers shall provide information on how to access 
the instructions for use in electronic form.  That information shall be provided as set out in the second 
subparagraph of paragraph 1 or, if not practicable, in a paper 
document supplied with each device.  
3. The information on how to access the instructions for use 
in electronic form shall contain the following:  
(a) any information needed to view the instructions for use;  
(b) a unique reference, giving direct access, and any other 
information needed by the user to identify and access the 
appropriate instructions for use;  
(c) relevant manufacturer contact details;  
(d) where, how and within which time instructions for use in 
paper form can be requested and shall be obtained at no 
additional cost in conformity with Article 5.  
4. Where a part of the instructions for use is intended to be 
provided to the patient, that part shall not be provided in 
electronic form.  
5. The instructions for use in electronic form shall be 
available entirely as text which may contain symbols and 
graphics with at least the same information as the instructions 
for use in paper form. Video or audio files may be offered in 
addition to the text.  
Article 7  
1. Where manufacturers provide the instructions for use in 
electronic form on an electronic storage medium together with 
the device or where the device itself is fitted with a built-in 
system visually displaying the instructions for use, the 
instructions for use in electronic form shall also be made 
accessible to the users through a website.  
2. Any website containing instructions for use of a device 
which are provided in electronic form instead of in paper form 
shall comply with the following requirements:  
(a) the instructions for use shall be provided in a commonly 
used format that can be read with freely available software;  
(b) it shall be protected against hardware and software 
intrusion;  
(c) it shall be provided in such a way that the server downtime 
and display errors are reduced as far as possible;  
(d) it shall mention in which Union languages the manufacturer 
provides the instructions for use in electronic form;  
(e) it shall fulfil the requirements of Directive 95/46/EC;EN L 72/30 Official Journal of the European Union 10.3.2012(f) the Internet address as displayed in accordance with 
Article 6(2) shall be stable and directly accessible during 
the periods set out in points (9) and (10) of Article 5;  
(g) all previous versions of the instructions for use issued in 
electronic form and their date of publication shall be 
available on the website.  
Article 8  
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 
notified body during the procedure applicable for conformity 
assessment as referred to in Article 9 of Directive 90/385/EEC 
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.  Article 9  
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 
form.  
Where such instructions for use are provided through a website, 
this website shall fulfil the requirements set out in points (b), (e) 
and (g) of paragraph 2 of Article 7.  
Article 10  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
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 BARROSOEN 10.3.2012 Official Journal of the European Union L 72/31