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Case C-219/11 – Brain Products GmbH versus BioSemi VOF and others
The European Court of Justice has ruled that only products intended by their manufacturer to have a medical use are covered by the Medical Devices Directive (“MDD”). This decision is an important one for manufacturers of products which are not intended to be used for medical purposes but which have an ancillary (or even diagnostic) function and elucidates whether or not these products fall within or outside the scope of the MDD.
Brain Products versus BioSemi clarified whether a product that falls within the definition of a medical device pursuant to Article 1(2)(a) of the MDD must also be intended to be used for medical purposes by the manufacturer in order to qualify as a medical device. The decision of the Court follows the Opinion of Advocate General Mengozzi and agreed that it is the manufacturer’s intended use for the product which will determine whether or not it falls within the ambit of the MDD. Accordingly, emphasis must be placed on the manufacturer’s description of the product and supporting information in establishing the intended use of the product. Indeed, the Court stated that: “as regards the context of …Article 1(2)(a) of the [MDD], it must be stated that, according to its title, that directive concerns ‘medical’ devices.&r dquo; Furthermore, the Court referred to the Commission’s guidelines (MEDDEV 2.1/1, published April 1994) which explicitly state that “medical devices are…articles which are intended to be used for a medical purpose”.
Commenting on the decision, Maria Isabel Manley (Head of Bristows’ Regulatory Practice) said that:
“The ruling is a seemingly sensible one and reinforces that it is the manufacturer’s intention and the information which the manufacturer provides with the product which will determine whether the device is intended as a medical device and consequently falls within the scope of the MDD. Manufacturers of products not intended for use as medical devices can now take some measure of comfort from this decision, as it adds clarity to an uncertain area and removes the additional financial and regulatory burdens of complying with the MDD for products that are not intended to be used for medical purposes.
Taking a more literal interpretation of the MDD would result in many everyday items such as toothbrushes or false nails being considered as medical devices which is undoubtedly not the intention of the MDD. However, manufacturers must take note as it remains to be seen how the courts will apply this decision to a product clearly intended to be used solely for a medical purpose, when the manufacturer does not describe it as such.”
Notes
- The full title of the case is Case C-219/11, Brain Products GmbH v BioSemi VOF and Others
- For further information, please contact Maria Isabel Manley (Head of Bristows’ Regulatory Practice) by e-mail ([email protected]) or by phone (020 7400 8000).
- Bristows has one of largest Life Sciences groups in Europe. The Regulatory Practice serves the most heavily regulated industries globally including leading pharmaceutical and biotechnology companies and major producers of medical devices, chemical products, food and cosmetics.
