Is Combination Product regulation available for Europe?

[SGquality]

Similar to 21 CFR Part 4 (Combination Products) in the US, does EU have a similar concept ?

 

[Sarah Stec]

Re: Is Combination Product regulation available for Europe ?

It does, but there's no one regulation that governs them, unlike 21CFR 4. They're also defined a little differently than the FDA does. See MEDDEV 2.1/3 rev. 3 and the MDD.

 

[SGquality]

Thanks Sarah