European Union: EU Regulation On e-Labeling Of Medical Devices Expected To Enter Into Force End This Year

Last Updated: 16 September 2011
Article by Erik Vollebregt

On 8 June the European Commission published a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities.

Up to now, e-labelling was problematic and regulated in a fragmented way. It was allowed up to an extent for IVDs within the guidance provided by a MEDDEV. This proposed regulation does not seem to change the rules for IVD e-labeling because the regulation explicitly applies only to the labelling of devices under directives 93/42 and 90/385. New IVD e-labelling rules may be taken on board in the currently pending revision of the IVD directive.

According to the Commission summary the scope of the draft regulation as follows:

to set out conditions according to which instructions for use in paper form may be replaced by electronic instructions for use. The regulation will limit the possibility of providing instructions for use in electronic form to defined medical devices and accessories intended to be used in specific conditions. Furthermore, it contains a range of procedural safeguards. Thus instructions for use have to be provided in paper form on request, and a specific risk assessment by the manufacturer and information on how to access to the instructions for use is needed.

This summary of course oversimplifies what the proposed regulation will actually do, so let's take a look at it in a bit more detail. As you will see, e-labelling is not for the meek and entails a lot of organisation. In addition, there is an important e-privacy angle to it that I predict many companies will overlook.

Paper push on request obligation

First of all, manufacturers will always remain subject to paper push upon request by user, for the duration of the data retention periods discussed below, and within maximum 7 calendar days or at delivery of the device.


The regulation will impact on four things:

  1. full e-labelling, whether via a carrier provided with the device or via a website
  2. e-labelling additional to paper IFU
  3. instructions for use provided via the device itself (e.g. via the GUI)
  4. labeling of the device itself

It will only regulate this for devices intended exclusively for professional users for use by other users is not reasonably foreseeable and that fall in either of the four below categories:

  • (active) implantable medical devices and their accessories intended to be used exclusively for the implantation or programming of a defined (active) implantable medical device;
  • fixed installed medical devices covered by Directive 93/42/EEC (fixed installed medical devices being defined as "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"); and
  • (active implantable) medical devices and their accessories with a built-in system visually displaying the instructions for use; and
  • stand alone software covered by Directive 93/42/EEC.

Obligations for full e-labelling

As a precondition manufacturers must perform a risk assessment on their e-labelling, the outcome of which must be 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" and it must "at least" include as elements:

  1. knowledge and experience of the intended users in particular regarding the use of the device and user needs;
  2. characteristics of the environment in which the device will be used;
  3. knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
  4. access of the user to the reasonably foreseeable electronic resources needed at the time of use;
  5. performance of safeguards to ensure that the electronic data and content are protected from tampering;
  6. 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;
  7. foreseeable medical emergency situations requiring the provision of information in paper form;
  8. 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;
  9. evaluation of the time period within which the instructions for use shall be provided in paper form at the users request.

The risk assessment must be updated with PMS information as and when that comes available, so manufacturers will need to include this in their PMS information feedback loop. As with the paper IFU the manufacturer must have a system in place to clearly indicate when the instructions for use have been revised. The regulation imposes an interesting mandatory vigilance obligation on this point: manufacturers must inform each user of the device of revisions of the IFU if the revision was necessary for safety reasons. It does not state how the users should be informed.

The regulation does not allow optional e-labelling per member state, unless justified by the outcome of the risk assessment. That means that e-labelling must be handled the same for each EU member state, unless it would be justified to make exceptions based on the risk assessment.

The regulation imposes data retention obligations and obligation to keep the e-IFU available for users :

  • for devices with a defined expiry date, except implantable devices, for at least two years after the end of the expiry date of the last produced device;
  • for devices without a defined expiry date and for implantable devices, for a period of fifteen years after the last device has been manufactured.

Since e-labelling must be fool-proof, the regulation sets out requirements for the instructions for use for the e-label.

Except for class I medical devices the notified body of the manufacturer must review the manufacturer's fulfillment of the e-labeling requirements during the p conformity assessment. The review must be based on a specific sampling method adapted to the class and the complexity of the product.


A full e-labelling website must comply with the following requirements:

  1. the instructions for use shall be provided in a commonly used format that can be read with freely available software (e.g. pdf);
  2. it shall be protected against hardware and software intrusion;
  3. it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;
  4. it shall mention in which Union languages the manufacturer provides the instructions for use in electronic form;
  5. it shall fulfil the requirements of Directive 95/46/EC (privacy and data protection, see for more detail about that below);
  6. the internet address shall be stable and directly accessible during the data retention periods (see above);
  7. all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website.

Additional e-labelling

Instructions for use in electronic form may also be provided in addition to complete instructions for use in paper form. In that case they must be "consistent" with the content of the instructions for use in paper form. If they are provided through a website, this website must fulfill part of the requirements for a full e-labelling webiste. Strangely enough the verification of consistency is not subject to ex ante notified body scrutiny as with the full e-labelling option. It will of course be subject to ex post notified body supervision in the framework of audits, so manufacturers might plan for this.

Impact on labeling of the devices themselves

Manufacturers must 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 time during the retention periods set out above. 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.

The manufacturer must provide

  • information on how to access the instructions for use in electronic form on the packaging for each unit or, where appropriate, onthe sales packaging or, in the case of fixed installed medical devices, also on the device itself. If all of that is not practicable, the information must be supplied in a paper document supplied with each device;
  • in 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; and
  • in the catalogue or in other appropriate device information support, information on software and hardware requirements needed to display the instructions for use (my guess is that this could also well be done somewhere in the documents comprising the label).

e-Labelling via the built-in GUI of a device

The draft regulation also deals with provision of instructions for use in electronic form by the device itself. Apart from that this is subject to all of the above, manufacturers of medical devices fitted with a built-in system visually displaying the instructions for use must ensure that displaying the instructions for use does not impede the safe use of the device, in particular life-monitoring or life-supporting functions. I think an example of this would be pop-ups with 'useful' troubleshooting tips that obscure vital information on the screen and cannot be easily closed. Fulfillment of this requirement will certainly impose additional emphasis on usability engineering requirements of the GUI of these devices and application of risk management to the software design process. Also, the instructions for use in electronic form must also be made accessible to the users through a website, to which all of the above criteria apply.

Don't forget the personal data rules impact

The draft regulation contains multiple references to the EU directive on the protection of personal data. This is to be expected because there will inevitably be an exchange of personal data between the manufacturer and a doctor or other HCP for the purpose of the provision of e-labelling and the PMS process related to that. That means that the processing of the personal data acquired has to meet all these general requirements, like no export from the EU except if allowed, use of data only within the scope of consent, procedures for correcting data, etc.

But let's not forget about other important data protection issues apart from the legacy EU data protection directive. The revised e-Privacy Directive that entered into force last May establishes, apart from all the upheaval about its cookie acceptance rules, for the first time in the EU, a mandatory personal data breach notification framework. This framework applies by the letter only to providers of publicly available electronic communications services (e.g., communications and Internet access providers). However, the EU Commission has already indicated that it will soon propose e-privacy legislation that will cover the entire scope of the providers regulated under the broader EU Data Protection Directive (yes, 95/46/EC, the one referred to in the draft regulation). Furthermore, recital 59 of the e-Privacy Directive encourages EU member states, while new EU Commission rules are in the pipeline, to apply the new data breach rules very liberally, "regardless of the sector, or the type, of data concerned." – ergo, e-labelling by medical devices manufacturers will soon fall under the e-Privacy directive and may already do so, depending on what EU member state you ask. I would say that compliance with the data breach rules will also need to be looked at by the notified body in the framework of its assessment of a manufacturer's e-labelling as this is very clearly a safety and PMS issue.

Under the new rules, providers must notify — without undue delay — individuals and authorities when they suffer a data breach. Individuals must be notified if the breach is likely to adversely affect the personal data or privacy of such individual. Regardless of the potential harm, all data breaches must be reported to the authorities. The notification should describe the nature of the breach, list the provider's contact information and recommend measures to mitigate possible adverse effects. The notification to the competent national authority must also describe steps taken by the provider to address the breach.

Notification of a personal data breach to an individual is not required, however, if:

  • the provider has demonstrated to the satisfaction of the competent authority (in this case the one for data protection, but a manufacturer will need to inform the notified body too and that may too have an opinion on this) that it has implemented appropriate technological protection measures;
  • the provider applied those measures to the data impacted by the security breach; and
  • the technological protection measures render the data unintelligible to any person not authorized to access it.

Both the scope of providers covered by the reporting requirements and the appropriateness of the technological protection measures are expected to diverge in implementation by the various Member States, making the jurisdictional issues very important because forum shopping may become an attractive option until these concepts are further harmonized.

Time path for entry into force

The regulation is proposed be adopted on 14 december this year and to apply as of 1 year after that date. This transitional period should be used by e.g. the manufacturers that are impacted by the user interface requirements to update the functioning of the GUIs and to get their e-labelling procedures in order.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.