Hello everyone. I hope you are all healthy and doing well. I have a question.
If the extension for applying the MDR takes place, a former Class I device that is upscaled to IIa (when passing from MDD to MDR) can be on the market until 2024 if it has a DoC (under the MDD) and doesn't have significant changes on the intended purpose, follows market and PMS, vigilance, registers EOs as for the MDR.
My question is: the application of DoC for these devices is May 2020 or May 2021? Thanks in advance!
If the extension for applying the MDR takes place, a former Class I device that is upscaled to IIa (when passing from MDD to MDR) can be on the market until 2024 if it has a DoC (under the MDD) and doesn't have significant changes on the intended purpose, follows market and PMS, vigilance, registers EOs as for the MDR.
My question is: the application of DoC for these devices is May 2020 or May 2021? Thanks in advance!