When will notified bodies be ready to perform audit to the MDR?

[snoopy2017]

Hi everyone,

Does anyone know when notified bodies will be ready to perform audit to the MDR? Say a company is planning an audit directly to the MDR requirements (and does not hold an MDD certificate so there is no transition), when should this company expect to have their first MDR audit?

A related question: does anyone know companies that still choose to be initially certified to the MDD during this 3-year transition?

Thanks

 

[L_O_B]

Hi snoopy,

By NBOG's plans: July 2019

There are some rumors that in a best case scenario the first notified bodies might be ready half a year earlier, i.e. at the end of 2018. But you should not count on that.

https://www.doks.nbog.eu/Doks/NBOG_BPG_2017_1_rev1.pdf

Some companies try to get their devices certified according to MDD, but noone can guarantee that the notified bodies will spare resources for MDD certificatication after they are notified under MDR. If you are planning this route, you should communicate with the notified body very early.