MDD or MDR Definition of metabolic

Ben S UK

Starting to get Involved
#1
Hello,

Hoping to understand whether there is any guidance or rulings on the definition of 'metabolic' within the context of the scope of the medical device regulations i.e. excluding products who's primary mode of action is metabolic.

Thanks

Ben
 
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Ben S UK

Starting to get Involved
#2
I seem to have answered my own question, and found the guidance in Meddev 2. 1/3 rev 3. This suggests that simple chemical processes, such as modifying pH would not be considered to be metabolic.

Although I seem to recall that the ECJ ruled - in the case of a medicine - more widely on the interpretation of metabolic and did include chemical modifications within that. But cannot find the ruling.
 
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