The decision took effect upon notification to EU countries, which took place on 9 August for all except for Spain and Cyprus, for which notification took place on 10 August. The decision was published in the Official Journal on 10 August.

The Commission decision stated that the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis, are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive.

The legal basis for this measure is Article 13 (1) (d) of the Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 on medical devices). This Article allows the Commission to take a decision, at the request of an EU country, on whether a product or product group falls within the definition of a ‘medical device’ according to Article 1 (2) (d) of the Medical Devices Directive.

More information

Commission Implementing Decision (EU) 2017/1445

EMA - CHMP Scientific Opinion on proanthocyanidins

Medical Devices in the EU