Online Safety Community

Advocate General Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices.

The AG’s opinion is not binding on the CJEU, but it provides useful guidance on the application of the EU medical devices Directive 93/42/EEC (the MDD) to software programs.  Importantly, it confirms the position set out in the Commission’s MEDDEV 2.1/6 guidance that software which merely stores and archives data is not a medical device; the software must perform an action on data (i.e., it must interpret and/or change the data).

EU national courts use the preliminary ruling procedure if they are in doubt about the interpretation or validity of an EU law. In such cases, they may ask the CJEU for advice. The Advocate Generals provide the CJEU with public and impartial opinions to assist the Court in its decision making. The Advocate Generals’ opinions are advisory and non-binding, but they are nonetheless influential.  In the majority of cases the CJEU follows the Advocate General.

Background

Philips France (Philips) manufactures and places on the EU market a software program called Intellispace Critical Care and Anesthesia (ICCA), which is used by physicians to provide information necessary for the proper administration of medicines for the purposes of resuscitation and anaesthesia.  The software highlights possible contraindications, interactions with other medicines and excessive dosing.  Philips classified the ICCA as a medical device under the MDD and the product bears a CE mark confirming that the software complies with the applicable requirements of the MDD.

Under French law, software programs intended to support medical prescriptions are subject to national certification requirements.  The French Government’s position is that the ICCA must comply with this national certification requirement. Further, it does not consider the ICCA to be a medical device within the meaning of Article 1(2)(a) of the MDD because the function of assisting with prescriptions does not fall under any of the defined purposes within the definition of a medical device.

Philips claimed that the national certification requirement should not apply as it amounted to a restriction on import, contrary to EU law, and that the French Government was in breach of Article 4(1) of the MDD, which provides that Member States must not restrict the placing on the market or the putting into service of medical devices bearing the CE mark within their territory.

The French Conseil d’État referred to the CJEU a request for a preliminary ruling on the question of whether software equivalent to the ICCA satisfies the definition of a medical device under the MDD.

AG Opinion

The AG opinion suggests that Philips had correctly classified the ICCA as a medical device.  It highlights that since the ICCA bears a CE mark and is freely marketed in 17 EU Member States, it benefits from a presumption of conformity with the MDD.  It was a matter for the French Government to rebut this presumption, and it had failed to do so.

In reaching his conclusion, the AG highlighted a number of points, including:

  • In order to qualify as a medical device, software must have a function beyond collection and archiving of data (i.e., it must have more than a purely administrative function). Rather, it must modify or interpret the data.  The ICCA software includes an engine that allows healthcare professionals to calculate the prescription of medications and the duration of treatments.  In light of such functions, the AG considers it difficult to maintain that the ICCA does not have a diagnostic or therapeutic purpose within the scope of the definition of a medical device. The ICCA is not a software program that is limited to administrative functions, but rather software that helps determine the proper prescription for the patient.  It is therefore a medical device as it has the aim of “preventing, controlling, treating or alleviating a disease”.
  • The fact that the ICCA does not act by itself in or on the human body does not preclude it from classification as a medical device. Contributing to the principal action of correcting the human body through the taking of medicinal products is sufficient.

The above conclusion endorses the position set out in the Commission MEDDEV 2.1/6 guidance on qualification and classification of standalone software, which states:

“…if the software does not perform an action on data, or performs an action limited to storage, archival, communication, ‘simple search’ or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device.”

Read More: https://globalcompliancepaneltraining.wordpress.com/2017/08/10/advo...

Views: 13

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted blog posts
1 hour ago
Bigclasses online training posted an event
Thumbnail

Become an SAP FICO Consultant- Learn SAP FICO from Experts at online

January 17, 2018 from 8am to 8pm
Learn SAP FICO from BigClasses. Now get the course only at Rs. 5310/-…. Hurry Up and Contact Now!!!BigClasses is a reputed and most trustworthy Online Training provider India. Students from USA, UK, Canada, Germany, Singapore and more has studied the professional IT courses from BigClasses. We have taught more than 5000 students over 10 years. Our Trainers are well-experienced and trained with the latest trends and technologies in the field.Trainers at BigClasses will prepare you with revised…See More
2 hours ago
Harris Scott posted blog posts
6 hours ago
Adam Fleaming posted a blog post

EDITORIAL – Conor O’Dea: A coup for Cayman Finance

A standard disclaimer in investment literature warns that “past performance is not indicative of future results.” But in the case of Conor O’Dea, the financial services veteran recently selected as chairman of Cayman Finance, a waiver of that warning would be perfectly appropriate.Mr. O’Dea’s sterling professional track record, decades in the making, gives us confidence in his ability to lead Cayman Finance, along with CEO Jude Scott, to new altitudes of success.The new Cayman Finance chairman…See More
6 hours ago

Forum

What's your favorite motivational/safety quote? 103 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by Lissa on Thursday.

Python Online Training by QA Training Hub

QA Training Hub is best Python Programing Online Training Center in India. Python Online Training provided by real time working Professional Mr. Dinesh. Data Scientist and RPA Expert  with 18+ years…Continue

Tags: Bangalore, delhi, Hyderabad, best, institute

Started by sonyagarwal Jan 3.

Business Intelligence with Big Data happens at Unipê 1 Reply

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri. Last reply by Manchun Jan 2.

VMware player error on install vmware tools. 1 Reply

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa. Last reply by Manchun Jan 2.

Forklift Training in Calgary

Do you wish to learn forklift driving? A forklift is a type of industrial vehicle that firstly lift the material and then transport it. The forklift machine is capable of lifting heavy loads by…Continue

Started by Gurjinderpal Sandhu Dec 27, 2017.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service