The European Commission has finally adopted in August 2017 the DECISION (EU) 2017/1445 on the qualification of cranberry products. The Decision states that these group of products whose intended action is to prevent or treat cystitis, do not fall within the definition of medical devices set out in point (a) of Article 1(2) of Directive 93/42/EEC.
The Decision follows the EMA´s scientific opinion of 22 July 2016 which noted that the suggestion of the totality of data principal intended action of this group of products is most probably pharmacological and not a mechanical mode which would qualify them as medical devices.
What is next?
The decision on how the transitional periods would last and apply, is a matter that shall be developed at national level by each Member State and on a case-by-case basis.
It is expected a pragmatic approach considering there have not been safety issues related with these products.
Author: Ana Alvarez. Azierta Corporate Director