Hi All,
I would like to inquire with regard to the difference between the MDR conformity assessment route for Class IIa devices. From my understanding there are three types of route which the manufacture may be able to choose from which includes:
1. Annex IX Chapter I & Section 4
2. Annex II & III coupled with Annex XI section 10
3. Annex II & III coupled with Annex XI section 18
As we are in development phase and need to plan out a lead time for NB conformity assessment, I would like to seek for members expertise with regards to what difference are there between option 2 and option 3 and which one of the assessment route is suitable for our device. The device will be a substance based Class IIa, classified via Annex VIII Rule 21 third indent.
Thanks heaps for your help
I would like to inquire with regard to the difference between the MDR conformity assessment route for Class IIa devices. From my understanding there are three types of route which the manufacture may be able to choose from which includes:
1. Annex IX Chapter I & Section 4
2. Annex II & III coupled with Annex XI section 10
3. Annex II & III coupled with Annex XI section 18
As we are in development phase and need to plan out a lead time for NB conformity assessment, I would like to seek for members expertise with regards to what difference are there between option 2 and option 3 and which one of the assessment route is suitable for our device. The device will be a substance based Class IIa, classified via Annex VIII Rule 21 third indent.
Thanks heaps for your help