On 15 May 2012, the Advocate General published his Opinion in the European Court of Justice reference in Brain Products GmbH v BioSemi VOF and Others by the German Supreme Court (Bundesgerichtshof). Medical device manufacturers generally but also manufacturers of software products intended to be used in a healthcare context should take note of this Opinion, which is significant for two reasons:
- it clarifies for the first time whether a product that meets one of the medical purpose definitions set out in the MDD must also be intended to be used for a medical purpose to qualify as a medical device under the Medical Devices Directive 93/42/EEC (“MDD”) and what should be taken into account in inferring such “intention”.
- it also contains analysis on modular products which may be relevant to manufacturers, particularly of software products used in the healthcare environment, which are in some cases qualified as medical devices.
The German action was initiated by a competitor against BioSemi, which markets a product called ‘ActiveTwo’, a modular system capable of recording electrical signals from the human body and, more specifically, from the brain, heart and muscles. Although measurements of this nature are frequently taken in a healthcare context, ActiveTwo is not designed for the medical sector and the manufacturer’s products and promotional material states that it is not designed to be used for diagnosis and/or treatment. The primary users of the product are researchers carrying out investigations particularly related to the cognitive sciences. ActiveTwo does not bear a CE mark under the MDD. The competitor argued for a literal interpretation of the definition and that if the product was capable of medical use it should be CE-marked as a medical device regardless of its intended use.
The Bundesgerichtshof has asked the question: “Does a product which is intended by the manufacturer to be applied to human beings for the purpose of investigation of a physiological process constitute a medical device within the terms of Article 1(2)(a) of Directive 93/42/EEC only in the case where it is intended for a medical purpose”. The short answer to that question in the Advocate General’s view is “Yes”.
Key Issues from the Opinion
Intended for a medical purpose
- The Advocate General prefers a ‘systematic and teleological’ against a ‘literal’ interpretation of the definition of a medical device.
- Whether a product is intended to be used on patients is likely to be important. It was significant in this case that the manufacturer intends its products used be only on clinical trial participants in the field of cognitive sciences – who do not qualify as patients.
- The MDD definition to the manufacturer’s intention that the product should be used for “human beings” rather than for human beings for medical purposes.
- The manufacturer’s information is key. However, if a product, by its very nature, is clearly intended to be used solely for a purpose of a medical nature it will have to be regarded as a medical device even if the manufacturer does not describe it as such in order to avoid abuse.
- Standalone software will qualify as a medical device if it is “intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for [the] proper application [of the device]”. The definition in this case specifically addresses the need for the manufacturer to intend the software’s use for the specified medical purposes.
- Although it is a combined hardware and software product the ActiveTwo system is modular and part of its attractiveness to users is recognised to be the ease by which the user can configure the products to suit the user’s purposes. The Advocate General notes that it is “precisely the intrinsically flexible nature of the ActiveTwo system that would make it impossible to make that system subject to certification as a medical device”. This view contrasts with the position adopted under the European Commission’s recent MEDDEV on the qualification and classification of stand-alone software published in January 2012 (2.1/6) which requires manufacturers of stand-alone software products to isolate and to CE mark individual modules where these are qualified as medical devices, where the overall software product is of a modular nature. A link to our previous Law-Now entitled "When Does Software Become a Medical Device?" can be found here.
We now await publication of the final judgment to see if the court follows the Advocate General’s Opinion.
A link to the Advocate General opinion can be found here.