New Device Post Market Requirement for MDR

D

D&MGC

Registered
I am working on a submission for a Class IIa device that new to the EU market. Do I have to supply post market data or just plans with the intial submission?
 
Raisin picker

Raisin picker

Quite Involved in Discussions
If it is completely new (and not just a new version), I think that a PMS and PMCF plan would be sufficient.
But, if you do have data, what reason would there be not to use it? It will only support your claims of safety.
Depending on the claims you make in the CER, your NB might ask to see that data anyway.
 
ChrisM

ChrisM

Quite Involved in Discussions
If the device is new to the market, there won't be any post-market data for it. What you will have is the result of clinical trials etc that were conducted during development, plus a post-market surveillance plan, and these need to be submitted
 
Raisin picker

Raisin picker

Quite Involved in Discussions
There might, of course, be PMS data from other markets. The OP states "new to the EU market", so he could have data from US, PRC, Brazil ...

Be aware, however, that not all data might be usable. If the population is different to the EU population in an aspect relevant to your device, you have to justify the use of the data.
 
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