What is the Success Rate in CE Mark Certification for Medical Devices?

[Sarah Stec]

I agree that you're probably not going to find these rates except through the individual EU Competent Authorities. NBs don't publish this data (I'm not sure of the exact reason, but the first thing that comes to mind is that it could imply the duty of confidentiality we have). But the Competent Authorities could have data on the numbers of new devices registered in the country each year, which could indicate the numbers of devices that gain CE marking that year. Make sure to check more than one competent authority to get a more accurate number, since sometimes manufacturers decide (for various reasons) register their device in one country, but not another.

Hope this helps!

 

[Andrea.Ruth]

Re: What is the success rate in CE mark certification for medical devices ?

There are certain class III products that are cleared through the 510(k) process (you need predicate device, and to meet the requirements for a 510(k) submission. However, the vast majority do go through the PMA process.

Remember 510(k) clearance satisfies the requirement for premarket approval.

 

[wrodnigg]

what is the success rate for CE mark certification a new medical device application ?

Could you please clarify your question

Which kind of "success" do you mean?

Getting the certificate from the NB?
Not being spotted and shut down by authorities?

I did three certification audits in the USA last month and all three "passed".

From the view of quality management, it is not so hard to pass the requitements, but we had couple of devices which failed in the technical part according EN 60601-1 and 60601-2-X.