EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the group of products whose principal intended action, depending on 
proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon), is to prevent 
or treat cystitis    
EN 2   EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the group of products whose principal intended action, depending on 
proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon), is to prevent 
or treat cystitis  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europe an Union , 
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices1, 
and in particular Article 13 (1)  thereof,  
Having regard to the request submitted by France in accordance with Article 13 (1) (d) of th is 
Directive , 
Whereas:  
(1) France has requested the Commission in accordance with Article 13 (1) (d) of Council 
Directive 93/42/EECC to take a decision that the group of products whose principal 
intended action , depending on proanthocyanidins (PAC) present in cranberry 
(Vaccinium Macrocarpon)  extract , is to prevent or treat cystitis, does not fall within 
the definition of medical devices set out in point (a) of Article 1(2) of Council 
Directive 93/42/EEC.  
(2) The definition of a medical device set out in Article 1(2)(a) of Council Dir ective 
93/42/EEC provides among others that a device falls within that definition if it does 
not achieve its principal intended action by pharmacological, immunological or 
metabolic means.  
(3) The European Medicines Agency (EMA)  in its opinion of  22 July 20162 concluded 
that the principal intended action of the group of products mentioned in recital (1)  is 
achieved probably by pharmacological means  as metabolites of PAC and other 
constituents of cranberry exhibit most probably a pharmacological activity  and tha t a 
mechanical mode of action of PAC is highly unlikely.  
(4) The mechanical mode of action would indicate that  the group of products in question 
fall within the definition  of medical devices. As such a mode is highly unlikely and a 
pharmacological mode of acti on is most probable, this indicates that the group of 
products in question should not  fall within the definition  of medical devices.  
(5) Results of a questionnaire circulated at the Medical Devices Expert Group in 
November 2014 showed that the majority of Member States, bas ed on their scientific 
expertise, is of the view that this group of products should not fall within the definition 
of medical devices.  
                                                 
1 OJ L 169, 12.7.1993 , p. 1.  
2  CHMP (Committee for Medicinal Products for Human Use) scientific opinion to DG Internal Market, 
Industry, Entrepreneurship and SMEs, Unit GROW D.4. "Health Technology & Cosmetics" on the 
principal mode of action of proanthocyanidins intended to be used for prevention and treatment of 
urinary tract infections, EMA/427414/2016 , http://ec.europa.eu/growth/tools -
databases/newsroom /cf/itemdetail.cfm?item_id=8684&lang=en .   
EN 3   EN (6) The measures provided for in this Decision are in accordance with the opinion of the 
Committee  establi shed by  Article 7 (1) of Council Directive 93/42/EEC . 
 
HAS ADOPTED THIS DECISION:  
Article 1  
The group of p roducts whose principal intended action, depending on proanthocyanidins 
present in cranberry (Vaccinium Macrocarpon) extract, is to prevent or treat c ystitis, does not 
fall within the definition of  medical devices set out in point (a) of Article 1 (2) of Council 
Directive 93/42/EEC . 
Article 2 
This Decision is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Clau de Juncker