CE marking time


Involved In Discussions
Hi Everyone,

Does anything know what sort of time are we talking about if we want to get a NEW Class IIb product CE mark? I know it varies for NB and complexity of the device, but I guess with NB still busy dealing with the transition of legacy products to MDR, there may not be a lot of new products coming out or taking longer then expected, but what sort of timing are we talking about, 6, 9 or 12 months from submission to obtain CE marking?


Raisin picker

Quite Involved in Discussions
New, Class IIb: Better calculate with 18 months. When you find a NB at all. It does also depend on the device type (MDA/MDN codes), since the NB often have limited resources for some types of devices.
Very bad in my experience: Software MDA0315. A lot of software was class I under MDD and is now class IIa/b under MDR. So NBs didn't need many software experts under MDD, hence they are scarce now. I heard of a waiting list of up to one year for the first assessment round (in rare cases).

Just today, I received this list of "coverage of designation codes for notified bodies designated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR)".

Ed Panek

QA RA Small Med Dev Company
Super Moderator
Our NB is predicting 18-24 (After admin review and acceptance) for CE clearance for our iia.
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