A recent court ruling addressed the need for a stated medical purpose for a product to be covered by the European medical device directives. This article summarises for manufacturers the findings on this important concept.
On November 22, 2012, the European Court of Justice in the Case C-219/11 stated:
“The third indent of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as meaning that the concept of ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.”
The device subject to the court ruling was a device that investigated physiological processes by recording brain activity but for no specified medical purpose: it did not help the diagnosis of any medical condition and it did not treat any medical condition. So, the court deemed that this was not a medical device and did not fall under 93/42/EEC; even though similar products were marketed by different manufacturers as diagnostic equipment and were subject to Directive 93/42/EEC.
SGS considers the same principle would apply to products with no medical purpose but were similar to medical devices that treated a medical condition or were similar to an in vitro diagnostic medical device. An example of such a product with no medical purpose would be a product to measure heart rate for sports or fitness training purposes.
Manufacturers should note that it is not possible to avoid EC medical device directives for products that will be used for medical purposes by an absence of a stated intended purpose. If manufacturers wish to place on the market devices with no intended medical purpose, then the instructions for use should clearly state the actual purpose and should make clear that the product is not to be used as a medical device.
This judgement confirms the current view of SGS and so no change is to be made on the way SGS interprets the directives.
Further details can be found here.