Is Combination Product regulation available for Europe?

SGquality · Jan 15, 2015

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

Sarah Stec · Jan 15, 2015

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 · Jan 19, 2015

Thanks Sarah

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Is Combination Product regulation available for Europe?

SGquality

Quite Involved in Discussions

Sarah Stec

Involved In Discussions

SGquality

Quite Involved in Discussions

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