EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/B2/XXXX PE LABELLING   
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
XXX 
on electronic instructions for use of medical devices 
(Text with EEA relevance) 
EN 2   EN  
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 devices2, 
and in particular Ar ticle 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 us e in electronic 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 ef ficiency users should always 
have the possibility to obta in those instructions for us e 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 t hose instructions for use in electronic form and about the 
right to request the inst ructions 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 inst ructions for use in 
electronic form should also be  available through a website. 
(6) Regardless of the language obligations im posed on manufacturers by the law of the 
Member States, manufacturers who provide inst ructions for use in electronic form should 
indicate on their website in which Union la nguages those instructions are available. 
(7) Except for medical devices of Class I, as de fined in Annex IX to Directive 93/42/EEC, 
the fulfilment of the obligati ons 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. 
                                                
 
1 OJ L 189, 20.7.1990, p. 17. 
2 OJ L 169, 12.7.1993, p. 1.  
EN 3   EN (8) As the protection of the right to privacy of natural persons with respect to the 
processing of personal data should be ensu red by manufacturers and notified bodies as 
well, it is appropriate to provide that website s 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 protectio n of individuals w ith regard to the 
processing of personal data and on the free movement of such data3. 
(9) In order to ensure safety a nd 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 rela tion 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 Regulati on 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 a nd in point 13 of Annex 
I to Directive 93/42/EEC may be provided in el ectronic form instead of in paper form.  
It also establishes certain re quirements concerning instructions  for use in electronic form 
which are provided in addition to complete instru ctions for use in paper form relating to their 
contents and websites.  
Article 2 
For the purposes of this Regulation, th e following definitions shall apply: 
(1) "instructions for use" means information provided by the manufacturer to inform the 
user of the device of its safe and proper us e, of its expected performances and of 
any 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;  
(2) "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 manufacturer together w ith the device, or instructions for use 
available through a website;  
 (3) "professional users" means persons using the medical device in the course of their 
work and in the framework of a professional healthcare activity;  
                                                
 
3  OJ L 281, 23.11.1995, p 31.  
EN 4   EN  (4) "fixed installed medical devices" mean s devices and their accessories which are 
intended to be installed, fastened or ot herwise 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 whic h are not specifically intended to be used 
within a mobile healthcare facility. 
Article 3 
1. Subject to the conditions set out in paragraph 2, manufacturer s 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 exclusivel y for the implantation or programming of 
a defined active implantable medical device; 
(b) implantable medical devices and their a ccessories covered by  Directive 93/42/EEC 
intended to be used exclusively for th e 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-i n system visually displaying the instructions for use;  
(e) stand alone software cove red by Directive 93/42/EEC. 
2. Manufacturers may provide instructions for use in  electronic form inst ead of in paper form 
for the devices listed in paragra ph 1 under the following conditions:  
(a) the devices and accessories are intended for exclusive use by pr ofessional users,  
(b) the use by other persons is not reasonably foreseeable. 
Article 4 
1. Manufacturers of devices referred to in Artic le 3 that provide instructions for use in 
electronic form instead of in paper form shall undertake a documented risk assesment 
which shall cover at least the following elements: 
(a) knowledge and experience of the intended us ers in particular rega rding the use of the 
device and user needs;  
(b) characteristics of the environmen t in which the device will be used; 
(c) knowledge and experience of the intended us er of the hardware and software needed 
to display the instructions for use in electronic form; 
(d) access of the user to the reasonably fore seeable electronic resources needed at the 
time of use;  
EN 5   EN (e) performance of safeguards to ensure th at 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 elec tronic 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 unavailab ility 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 fo r use in electronic form shall be 
updated in view of the experience ga ined in the post-marketing phase. 
Article 5 
Manufacturers of devices referred to in Arti cle 3 may provide instructions for use in 
electronic form instead of in paper form under the following conditions:  
(1) the risk assesment referred to in Ar ticle 4 shall demonstrate that providing 
instructions for use in electronic form mainta ins 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; 
(3) they shall have a system in place to prov ide 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 seven 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, inform ation 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 verification a nd 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 lif e-monitoring or life-supporting functions;  
EN 6   EN (7) they shall provide, in their catalogue or  in other appropriate device information 
support, information on software and hard ware 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, ex cept implantable devices, they shall keep 
the instructions for use available for the user s in electronic form for at least two years 
after the end of the expiry date of the last produced device; 
(10) for devices without a defined expiry da te and for implantable devices, they shall 
keep the instructions for use available for th e users in electronic fo rm for a period of 
fifteen years after the last device has been manufactured. 
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 and that the user may request and shall obtain at no 
additional cost the instructions for use in paper form at any tim e during the periods set out in 
points (9) and (10) of Article 5.  
That information shall be provided on the packaging for each unit or, where appropriate, on 
the sales packaging. In the case of fixed installe d 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 provide d as set out in the second subpa ragraph of paragraph 1 or, if 
not practicable, in a paper document supplied with each device.  
3. The information on how to access the instructi ons for use in electron ic form shall contain 
the following:  
(a) any information needed to vi ew the instructions for use; 
(b) a unique reference, giving direct access, and any othe r information needed by the 
user to identify and access the appropriate instructions for use; 
(c) relevant manufactur er contact details;  
(d) where, how and within which time inst ructions for use in paper form can be 
obtained. 
4. Where a part of the instructions for use is in tended to be provided to the patient, that part 
shall not be provided in electronic form.   
EN 7   EN 5. The instructions for use in electronic form sh all be available entirely as text which may 
contain symbols and graphics with at least the sa me 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 th e instructions for use in electronic form on an electronic 
storage medium together with the device or wh ere the device itself is fitted with a built-in 
system visually displaying the inst ructions 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 co mply 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 la nguages the manufacturer provides the 
instructions for use in electronic form; 
(e) it shall fulfil the requirements of Directive 95/46/EC; 
(f) the internet address as di splayed in accordance with Article 6(2) shall be stable and 
directly accessible during th e 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 defi ned 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 procedur e applicable for conformity a ssessment as referred to in 
Article 9 of Council Dir ective 90/385/EEC or Artic le 11 of Council Di rective 93/42/EEC. The 
review shall be based on a specific sampling me thod adapted to the class and the complexity 
of the product. 
Article 9 
Instructions for use in electronic form which ar e 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 we bsite shall fulfil the 
requirements set out in points (b), (e) and (g) of  paragraph 2 of Article 7.  
EN 8   EN Article 10 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union .  
It shall apply from [twelve months af ter the date of entry into force]. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission