Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

EAR costs and recommendations under MDR

#1
Hello all,

We registered our class 1 (NS and NM) medical device an EAR under the MDD recently after paying a fair amount in registration and notification costs. The EAR has now would like us to sign a new mandate under the MDR. The new mandate requires us to 1) pay a monthly consultant fee 2) monthly EAR fee 3) one time fee to register the medical device on EUDAMED plus 5) one time fee to issue certificates.

I would like advice on whether these costs are acceptable and also seek reccomendation on a reliable and fairly priced EAR under MDR.
 
Paid Advertisement - Forum Supporter
Top Bottom