Impact to clinical evaluation of MDCG2022-14

[Soog1459]

Could someone explain more information or provide your guess regarding No.17 of MDCG2022-14?

We're struggling transition to MDR of Class II device. Major reason is clinical evaluation. Our market share is small AND field where almost no innovation or technology update was happened in last 10years, so it is very hard to find published literature of our device. Even more difficult to find evidence for children and pregnat/lactating woman.
I'm expecting that the additional guidance become helpful to solve our issues.

What kind of guidance, addition to MDCG2020 -5 & -6, is MDCG trying to publish??
NB may accept limited clinical evidence in condition to do some special activity in PMCF?

 

[SvonK]

Unfortunately, I can't help you here either. We are also waiting for a statement or interpretation from elsewhere.
In a way, we have the same problem that not much has happened in the field of DICOM viewers.

 

[Soog1459]

Unfortunately, I can't help you here either. We are also waiting for a statement or interpretation from elsewhere.
In a way, we have the same problem that not much has happened in the field of DICOM viewers.

Thank you for your repky. Lets see what will happen.