S SGquality Quite Involved in Discussions Jan 15, 2015 #1 Jan 15, 2015 #1 Similar to 21 CFR Part 4 (Combination Products) in the US, does EU have a similar concept ?
S Sarah Stec Involved In Discussions Jan 15, 2015 #2 Jan 15, 2015 #2 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.
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.
