Hello ,
Can anyone help me for my below question
We are planning to prepare a technical documentation as per Annex II, for one of our product classified as Class IIb Rule 10 of EU MDR. We have different model in same device group . Let say A80, A65, A50 , A40 & A15. Is it necessary to provide all the product detail in each section of lower variants such as A65~ A15 . for example, providing the user manual of all the lower variants in Technical documentation , although all the technical details provided in Device description section for these models. A80 model is the highest model and contains all the features of its lower variants.
Providing the technical documentation of A80 model is not sufficient .