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How to certify a Class IIa Medical Device

#1
Hello,
I have a product that would fall into class IIa. I would like to certify.
Do you think that it is possible without much foreknowledge?
Can the notfied body help with everything and is it then too expensive?
What will change in May 2020?

thanks

best regards
 

paulag

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#2
Hello,
I have a product that would fall into class IIa. I would like to certify.
Do you think that it is possible without much foreknowledge?
Can the notfied body help with everything and is it then too expensive?
What will change in May 2020?

thanks

best regards
Hi Bwin,

without any Kind of knowledge or at least deep understanding of the regulations, it will really be a difficult task. Possible maybe, but not lean or effective or smooth or... you name it
The notified body will are probably not write your procedures for risk management, your clinical evaluation, or your SOPs, neither will they compile your technical documentation for CE marking... Not sure how much help you need in which area, but better get yourself some kind of external support?!

There are many changes in almost all areas between the MDD and MDR - search the net for whitepapers written by notified bodies or consultants for an brief overview, then study the regulation to make sure you identify the changes that apply to your specific situation
 
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