A ruling by the EU Court of Justice last month might make it less clear what the difference is between the definition of medical devices and devices for general health, according to life science and IP lawyer Erik Vollebregt, who blogs about medtech matters on medicaldeviceslegal.com.
The case Brain Products GmbH v BioSemi VOF concerns the definition of medical devices in the Medical Device Directive and specifically if Biosemi’s ActiveTwo, a device recording brain activity, is a medical device. The EU court ruled that a device is considered medical if it is “intended for a medical purpose.” The court further ruled that “…in situations in which a product is not conceived by its manufacturer to be used for medical purposes, its certification as a medical device cannot be required”.
The ruling is problematic because it relies on the manufacturer’s intent and definition of a medical purpose, instead of a more objective measure, and it fails to define exactly what medical means, Vollebregt says.
“We still don’t know what ‘medical’ means as opposed to the more general term ‘health’”, says Vollebregt. The EU Court seems to mix up these terms in the judgment, and surely does not clarify the term medical very much except by saying that articles that do not have a medical intended purpose, like sporting goods, should not be regulated as medical devices.”
The ruling will potentially broaden the scope of the Medical Device Directive (MDD). It could also enlarge the scope of the proposed medical device regulations (MDR), says Vollebregt. The medical device regulations will enter into force in the next few years. “This difficult borderline between medical and health will not be resolved in the MDR,” says Vollebregt.
For a more detailed look on what this ruling means, read Vollebregt’s blog post A medical device is medical – but what does that mean?Camilla Andersson