The Court of Justice of the European Union (CJEU) interprets EU law to ensure that it is applied in the same way in all EU countries. It also decides on disputes between national governments and EU institutions. In certain cases, private individuals, companies or organizations can bring it into a dispute with an EU institution if they believe it has violated their rights. The CJEU’s rulings are important not only for the parties involved in the case. The interpretations by the CJEU are taken up by national courts in its grounds of judgement and provide guidance in the legal literature. Moreover, they clarify the role of legally non-binding documents as MEDDEV guidances or harmonized standards. In this article we have compiled and explained some important CJEU judgements on medical devices.
Software as Medical Device Case C-329/16
addressed the question of whether a particular software is a medical device
. It concerned software capable of detecting contraindications, interactions or overdoses of drugs. The CJEU confirmed this on 7 December 2017. According to the CJEU, the definition of a medical device according to the EU Medical Device Directive (EU MDD
) is fulfilled. Art. 1 (2) refers here to the recognition, prevention, monitoring, treatment or alleviation of diseases as well as injuries or disabilities and their compensation. The definition of the EU MDD also requires that medical software
acts directly in or on the human body. Here, however, the CJEU considered that this part of the EU MDD definition was not relevant in the present case.
Tasks and Obligations of Notified Bodies
Patients have suffered considerable health damage due to defective hip and breast implants. This leads to the question to what extent a notified body
is liable and what obligations result from this? In its judgment of 16 February 2017 (Case C-219/15
), the CJEU states that the respective national courts must decide on patients’ claims for damages and damages for pain and suffering on the basis of the national liability
provisions. As a consequence, the CJEU has no general obligation for notified bodies to carry out unannounced inspections and to inspect products or documents of the manufacturer. However, the situation is different if the notified body becomes aware that a medical device does not comply with the legal requirements. The notified body must then take appropriate measures. Note that in the meantime the duties of a notified body have been regulated much more strictly in Annex VII of the EU MDR
Harmonized Standards in the Light of the “New Approach”
Harmonized standards are developed under a mandate from the EU Commission and published in the Official Journal
of the EU. The European legislator assumes in its application that the (medical) devices meet the basic requirements of the Medical Devices Directive. In its ruling of 27 October 2016 (Case C-613/14
), the CJEU decided that harmonized European standards
actually define the essential requirements and are therefore part of Union law. Nevertheless, the application of harmonized European standards by the manufacturer remains voluntary.
Liability for Potentially Defective Medical Devices
Defective medical devices can cause damage to the patient’s health. The question comes up, who is liable? Is it necessary for each individual medical device from a product group or production series to prove that it is actually defective? The CJEU decided against this on 5 March 2015 (Case C-503/13
). Consequently, mere suspicion of a defect is sufficient to classify all products as defective. In addition, the manufacturer is liable for the replacement due. In the present case, this has resulted in a defective implantable cardioverter defibrillator being replaced by surgery.
Medical Purpose as a Prerequisite for Approval as a Medical Device
Is a device always a medical device when it is used to study a physiological process? The CJEU denies that. On 22 November 2012 (Case C-219/11
), the CJEU found that in the case of a device for recording human brain waves, it is only a medical device if it is intended for a medical purpose. Make sure that the purpose of a device is not arbitrarily stated by the manufacturer. The manufacturer cannot claim that the product does not serve any medical purpose, although this is obvious.
What is the Meaning of CE Marking of Medical Devices?
Public hospitals carry out procurement procedures for medical devices above a certain procurement amount. If the clinic is offered CE-marked medical devices, it may not reject them for safety reasons. If the clinic is of the opinion that the medical device in question is a health risk despite the CE marking, it must report this to the competent authorities. The clinic itself cannot carry out an independent conformity check. In its judgement of 14 June 2007 (Case C-6/05
), the CJEU again underlines the importance of CE certification. The CJEU’s interpretations of the European legislation on medical devices will continue to be of great importance in the future. This will be the case in particular in areas where the legal text is too little detailed or unclear.