European Union: Advocate General Endorses MEDDEV Guidance On Classification Of Software Programmes As Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona issued his opinion in Case C-329/161, the first case in which the Court of Justice of the European Union (CJEU) has been asked to consider the classification of software in the context of medical devices legislation. The issue to be addressed by the Court is whether a particular software programme, intended to be used by doctors to support prescribing decisions, falls within the definition of a medical device as provided by Directive 93/42/EEC (the Medical Devices Directive2). This Advisory considers the opinion of the Advocate General and the implications for digital health developers.

Background

The subject of the case is a software programme manufactured by Philips France. The programme, Intellispace Critical Care and Anesthesia (ICCA), is intended for use by doctors in anaesthesia and intensive care services to provide information with regards to possible contraindications, interactions with other medicines and excessive dosing, and therefore to support prescribing decisions. The ICCA has been CE marked as a medical device, confirming that it meets the essential requirements of the Medical Devices Directive and may be placed on the market throughout the EU.

The dispute in Case C-329/16 arose from the fact that French law3requires that software programmes designed to assist medical prescriptions should be subject to a national certification system. Philips France claimed that, by imposing a further requirement in addition to the conformity procedure laid down in the Medical Devices Directive, the French Government infringed Article 4(1) of the Directive, under which Member States must not restrict the placing on the market and putting into service of devices bearing a CE mark. The national certification system therefore amounts to a restriction on import of the device, contrary to EU law.

A question was, therefore, referred to the European Court from the French Conseil d'Etat for a preliminary ruling on whether the type of software in this case constitutes a medical device within the meaning of the Medical Devices Directive, in circumstances where the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing, but does not itself act in or on the human body.

Software as a medical device

Directive 2007/47/EC4amended the definition of a medical device at Article 1 of the Medical Devices Directive to include an express reference to software that is intended by the manufacturer to have one of the designated medical purposes. The 6th recital to Directive 2007/47/EC confirms: "General purpose software used in a medical environment is not a medical device".

This general principle that, in order to fall within the definition of a medical device, a product must be intended for a medical purpose has been confirmed by the European Court in relation to other types of products; for example, in the Brain Products decision5, the Court stated that a system for recording human brain activity was a medical device only when it was intended for medical use. However, the assessment is by no means straightforward when applied to software because, unlike general medical devices, it may not be immediately apparent whether the software is intended for a medical purpose, when it does not act directly on the human body to restore, correct or modify bodily functions.

European guidance has been developed to assist developers in determining whether software should be categorised as a medical device or whether it simply performs a general purpose within the context of the healthcare setting. Although not a legal text, the MEDDEV guidelines, prepared in collaboration with national authorities, industry, and the national accredited bodies, are considered to provide a valid systematic interpretation of the applicable legal framework.

Findings of the Court

In Case C-329/16, the French Government argued that the ICCA software does not satisfy the definition of a medical device within the meaning of Article 1(2)(a) of the Medical Devices Directive and could not therefore be marketed in France without the authorisation of the French authorities (the Haute Autorité Santé). They asserted that the ICCA's function of assisting the prescription process does not fall within the definition in the Directive, as the software itself does not make prescription decisions; they claimed its functions are purely administrative. Further, the French Government considered that, while some of the functionalities of the ICCA may have a medical purpose, these were not the modalities referred for consideration by the referring court. The fact that certain modalities might have a medical function does not mean that the whole programme should be classified as a medical device, as other aspects of the programme have purely administrative functions that do not create or modify data.

The Advocate General disagreed with the French Government's assessment, and found that ICCA should be classified as a medical device. The Advocate General's analysis of the device endorses the guidance set out in the MEDDEV as applicable to software,6 and from national competent authorities, such as the MHRA.7In particular, the Advocate General found the following factors to be important:

  • The ICCA software carries a CE marking and, therefore, benefits from the presumption of conformity with the Medical Devices Directive; in order to succeed in its case, the French Government is required to overturn that presumption, which it has failed to do.
  • The ICCA is not a programme of general use that is used in a healthcare setting; it goes beyond simple storage of data and modifies and interprets such data to calculate certain information that is useful for healthcare professionals to make proper prescribing decisions. As such, the ICCA has a therapeutic and diagnostic purpose in line with the definition of medical device. It is not necessary for the software itself to make the prescription decision, but providing support to healthcare professionals in prescribing medicinal products is sufficient to have a medical purpose.
  • The fact that the ICCA does not act directly on the interior or the surface of the human body does not prevent its classification as a medical device; a "contribution" to the principal intended action is sufficient.
  • The classification of the programme refers to all the functionalities and modules of the ICCA as a whole, and the functionalities cannot be separated and classified individually.
  • The Commission MEDDEV guidance and other guidance issued by the competent authorities of the Member States, including the MHRA and the French Medicines Agency (the ANSM), are aligned in their assessment of software, and classify programmes such as ICCA as medical devices.

The Advocate General, therefore, suggested that the CJEU should answer the question referred by the Conseil d'Etat as follows:

"Subject to the national court's assessment of its functionality, prescribing software such as that which is the subject of the present proceedings may be described as a medical device within the meaning of Article 1(2)(a) of Directive 93/42/EC of 14 July 1993 on medical devices in so far as it provides the physician with the information necessary to detect contraindications, interactions between drugs and excessive dosages".

The European Court will now consider this opinion and deliver a judgment in due course. While the Advocate General's opinion is not binding on the Court, it does help to clarify how to apply the existing regulatory criteria to medical software pending the Court's decision.

Footnotes

1. C-329/16 - SNITEM (Syndicat national de l'industrie des technologies médicales) and Philips France, 28 June 2017

2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

3. Decree 2014-1359 amending the French Social Security Code

4. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

5. C-219/11, Brain Products GmbH v BioSemi VOF and Others, 22 November 2012

6. Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand alone software - MEDDEV 2.1/6, July 2016

7. Medical device stand-alone software including apps, April 2017

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 Mondaq.com.

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

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
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 you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (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 www.mondaq.com

    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 Mondaq.com’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.

    Disclaimer

    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.

    Registration

    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.

    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 unsubscribe@mondaq.com 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.

    Cookies

    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.

    Links

    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.

    Mail-A-Friend

    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.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    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 webmaster@mondaq.com.

    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 EditorialAdvisor@mondaq.com.

    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 enquiries@mondaq.com.

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

    By clicking Register you state you have read and agree to our Terms and Conditions