Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory
Social Distancing - It's not just YOUR life - It's ALL of OUR lives!
Me <——————— 6 Feet ———————-> You

CE Marking requirements - A Medical device with different config sold under same name

#1
Hello,

I am new to QA/RA. Our device is classified as Class IIa(MDD) and Class 1 510(k) exempt (FDA).We are planning to produce next generation of our product early next year. Existing configuration is expected to be live until end of next year.
Already we are in the Design phase for configuration 2.

I would like to know the following:

MDD(EU)
Is it required to list the two configuration in CE Certificate in order to sell both the device configuration (without changing the trade name)? If yes, is that possible via a normal notification of change to Notified Body or do we have to follow a new submission process?

U.S FDA
Can we maintain separate DHF and DMR per configuration type?
Our current DHF is incomplete and we plan not to fix it as that particular configuration will soon be phased out.

Looking forward to your valuable suggestions.

Regards,
S.Rajesh
 
Top Bottom