EU Vote on First Borderline Decision: Cranberry Products Are Not Medical Devices
On 19th May, 2017, The European Commission’s Regulatory Committee on Medical Devices adopted the European Commission’s decision on the qualification of cranberry products, which states that cranberry products are not medical devices. This vote came more than one year after the draft decision issued in February 2016, and it is the first borderline decision adopted based on MDD Article 13(1)(d).
Cranberries have long been considered useful in reducing urinary tract infections such as cystitis, as they contain proanthocyanidins (PACs), which are stable phenolic compounds with anti-adhesion activity against Escherichia coli. Until recently, the classification of cranberry based products was unclear and they were marketed differently across the EU: as a food supplement, medical device or consumer product.
Key aspects of the “Cranberry Decision”
The “Cranberry Decision” was triggered by a French competent authority’s (ANSM) request to revoke the Class IIb medical device status of cranberry products patented by a French company. It was followed by a first draft decision of the Commission and the scientific opinion of the European Medicines Agency’s (EMA).
The key aspects of the final version of The Cranberry Decision are:
- The group of cranberry products whose primary intended action, depending on PACs present in cranberry extract, is to prevent or treat cystitis, does not fall within the definition of medical devices. within the meaning of Article 1 (2) (a) of the Medical Devices Directive.
- A mechanical mode of action (i.e. a mode of action typical for medical devices) of the PACs is highly unlikely.
- The metabolites of PACs and other constituents of cranberries most probably exhibit a pharmacological activity.
- The Commission’s opinion also states, that “there are gaps in the scientific knowledge on the mode of action of PACs”. As such, the PACs’ mode of action is still open for scientific discussion.
As Article 13(1)(d) of the Medical Devices Directive only allows the Commission to decide whether a product is a medical device or not, it will be up to the Members States’ competent authorities to determine which other regulatory classification applies, e.g. food supplements or medicinal products.
The formal adoption and publication of the “Cranberry Decision” is expected later this year.
Should you have any questions related to the classification of your medical devices, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any questions you may have and assist you in safeguarding the compliance of your devices.