Hello,
I have got a question regarding the improved technical documentation in the MDR. As I understand it, the medical device file (ISO:13485:2016 4.2.3) is similar to the DMR in the USA, so that the medical device regulation in Europe and the USA approach each other.
Do the MDR in Europe also implements something like a DHF or DHR in Europe? Or is a documentation about the design history in Europe not necessary?
Thank you all in advice,
greetings from Berlin!
Paul
I have got a question regarding the improved technical documentation in the MDR. As I understand it, the medical device file (ISO:13485:2016 4.2.3) is similar to the DMR in the USA, so that the medical device regulation in Europe and the USA approach each other.
Do the MDR in Europe also implements something like a DHF or DHR in Europe? Or is a documentation about the design history in Europe not necessary?
Thank you all in advice,
greetings from Berlin!
Paul