Hello,
I have a question about MDD Class I devices, their access to the EU market after May 2020 and their reclassification due to new MDR rules.
If I have a software medical device that is currently classed as a Class I device under MDD Rule 12 and is marketed by way of a DoC stating compliance with MDD.
After 26th May 2020, Class I devices must comply with the EU MDR, presumably by producing a DoC that states compliance to the MDR.
However, my MDD Class I piece of software will be recertified, under MDR Rule 11, as a Class IIa device.
What do I do to maintain market access after 26th May 2020?
Thanks
K
I have a question about MDD Class I devices, their access to the EU market after May 2020 and their reclassification due to new MDR rules.
If I have a software medical device that is currently classed as a Class I device under MDD Rule 12 and is marketed by way of a DoC stating compliance with MDD.
After 26th May 2020, Class I devices must comply with the EU MDR, presumably by producing a DoC that states compliance to the MDR.
However, my MDD Class I piece of software will be recertified, under MDR Rule 11, as a Class IIa device.
What do I do to maintain market access after 26th May 2020?
Thanks
K