Am currently working on my submission for a Class IIa Rule 7 Instrument and wondering whether anyone had any experience yet with the MDR review?
I'm expecting a 9-12 month lead time for the assessment, providing all goes well.
I would be curious to know of your experience as a lot of comments I read are based on people's suppositions and MDCG guidance documents
I'm expecting a 9-12 month lead time for the assessment, providing all goes well.
I would be curious to know of your experience as a lot of comments I read are based on people's suppositions and MDCG guidance documents