Conformity Assessment Route question for Class IIa medical device under MDR

[sugizo521]

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

 

[SKM.Sunil]

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

Class-IIa
Annex-II : Technical Documents
1. Annex-XI(A): CA by product conformity verification - Production Quality System -> Annex-XI- certificate by NB
2. Annex-XI(B): CA by product conformity verification - Product verification is done by NB -> Annex-XI- certificate by NB
Document to MDR by NB -> Annex-XI certificate -> CE by NB
There will be Annex Certification and CE certification.

In my opinion, your product may fall through path-1, because your product is applied to the oral or nasal cavity as intended (may be sterile)

 

[sugizo521]

Class-IIa
Annex-II : Technical Documents
1. Annex-XI(A): CA by product conformity verification - Production Quality System -> Annex-XI- certificate by NB
2. Annex-XI(B): CA by product conformity verification - Product verification is done by NB -> Annex-XI- certificate by NB
Document to MDR by NB -> Annex-XI certificate -> CE by NB
There will be Annex Certification and CE certification.

In my opinion, your product may fall through path-1, because your product is applied to the oral or nasal cavity as intended (may be sterile)

Thanks SKM.Sunil. Sorry for not being able to give too much information on the product, but it is only applied to intact skin and is not sterile. Therefore, will it be better to go with either option 2 or 3 for TD + Annex XI section 10 or section 18?

What I would like to know also is that what is the difference between Annex XI section 10 and Section 18? i.e. which type of device is more suitable for section 10 and which is more suitable for section 18? Thanks.

 

[SKM.Sunil]

Thanks SKM.Sunil. Sorry for not being able to give too much information on the product, but it is only applied to intact skin and is not sterile. Therefore, will it be better to go with either option 2 or 3 for TD + Annex XI section 10 or section 18?

What I would like to know also is that what is the difference between Annex XI section 10 and Section 18? i.e. which type of device is more suitable for section 10 and which is more suitable for section 18? Thanks.

In simple I can Say, these are paths to choose, there are no pre-mentioned devices:

Section 10 belongs to Part-A of Annex-XI: where the classification is confirmed by manufactured under the certified QMS. The NB will more focus on QMS (manufacturing) after confirming the technical/clinical claim of the device. NB then give Annex certification (that the device complies with this section of MDR), then proceed for CE.

Section 18 belongs to Part-B of Annex-XI: Where the declared classification will undergo scrutiny by the NB (product verification). Still, the Manufacture is under QMS. All technical/clinical claims will have to pass through tests specified by the NB. NB then give Annex certification (that the device complies with this section of MDR), then proceed for CE.

Now you as manufacture have to choose whether you can satisfy the NB/MDR with Section-10 or you need to choose section-18.

**if anyone has a different opinion. Please comment
Thanks