EU Member State Competent Authority Registration and EUDAMED

S

SoftwareasaMentalDevice

Registered
#1
#1
Hello everyone,

If manufacturer X has obtained MDR certification for a class IIb device and the device has been fully registered on EUDAMED, is manufacturer X still required to individually register the device with specific local competent authorities in the EU member states which demand that requirement?

Or does EUDAMED registration negate all further requirements for individual registration with EU member state Competent Authorities?

Cheers!
 
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P

Philip B

Quite Involved in Discussions
#2
#2
Not sure, as far as I know member state registration requirements are still in place. Perhaps they will all be eventually replaced by EUDAMED registration?
 
Raisin picker

Raisin picker

Quite Involved in Discussions
#3
#3
Also not sure, but use of EUDAMED ist not yet mandatory. That might be related to national registration requirements still existing.
 
B

Billy Milly

Involved In Discussions
#4
#4
Until Eudamed is mandatory, national registration is applicable. Future requirements will depend on the individual country once Eudamed is fully functional (I expect them to rely on Eudamed mostly). This registration should be pretty straightforward - registration is required in the "home state" of the manufactueter or AR if the manufacturer is not located in EU.
National notification (registration) is another topic. Many EEC countries require a notification before a certain product is placed on their market. Those are purely national requirements; no direct relation to MDD or MDR or whatever. Usually this can (shall) be done by the distributor planning to place a certain device on a certain (national) market, registration from the first indent is usually a prerequisite.
 
S

SoftwareasaMentalDevice

Registered
#6
#6
Thanks everyone! The consensus seems to be to continue with all applicable National notifications before placing the product on a specific european country's market until EUDAMED becomes fully functional and local governments change their policy.
 
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