CE Mark for Class III Medical Device - MDR or MDD applies?

Woodray

Starting to get Involved
#1
I am getting my ISO13485:2016 following the MDR which I will obtain by 1st quarter of 2019. I will then apply for CE Mark which will be under MDD 93/42/EEC as the CE Mark under MDR is not effective yet till May 2020. So the question is will I be able to apply for CE Mark under MDD 93/94/EEC with an ISO13485:2016 which has been issued under MDR. Also is there any documentation to back this up.

My TF SOP will be in two parts, prior to May 2020 following MDD and After May 2020 following MDR. Need some reference to back this up if correct

Thanks

Regards
 
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Rincewind

Involved In Discussions
#2
I am not entirely sure I completely understand the question but the ISO 13485:2016 is listed as a harmonized standard under the MDD 93/42/EEC. I would link you to the list of harmonized standards for MDD but as I am under 10 posts I am not allowed to post links.

So yes you will be able to apply for the CE mark under MDD.

I do not understand what do you mean by "ISO 13485:2016 has been issued under MDR". As far as I know there are no harmonized standards for the MDR, yet.

Furthermore the accreditation process, for NBs, for the MDR is still running, afaik. I doubt you will find a NB before mid 2019.
 

Marcelo

Inactive Registered Visitor
#3
I am getting my ISO13485:2016 following the MDR which I will obtain by 1st quarter of 2019. I will then apply for CE Mark which will be under MDD 93/42/EEC as the CE Mark under MDR is not effective yet till May 2020. So the question is will I be able to apply for CE Mark under MDD 93/94/EEC with an ISO13485:2016 which has been issued under MDR. Also is there any documentation to back this up.

My TF SOP will be in two parts, prior to May 2020 following MDD and After May 2020 following MDR. Need some reference to back this up if correct

Thanks

Regards
I think you are confusing a lot of different stuff here.

ISO 13485 (as any other standard) is not required by the MDD or MDR. You can use it to show conformity with parts of the requirements (the QMS requirements, including additional requirements in any conformity assessment route), but please note that, particularly with the MDR, there's some QMS requirements that are not present in ISO 13485 directly, so using only ISO 13485 alone cannot fulfill the MDR.

Also, ISO 13485 is not applied "under the MDD" or "under the MDR". It's applied by itself. If you mean a certification for ISO 13485 (which has nothing to do with the MDD, MDR or any other regulation), and this certification is accepted by the notified body, you can use it in any way you want.

You can apply for the MDR conformity assessment routes before May 2020. The only problem with now is, if you device is not a class I without sterility, measurement, or being a reusable surgical instrument, any route will require the involvement of a notified body, and we do not have any notified for the MDR right now.
 

Woodray

Starting to get Involved
#4
I am the first to admit that I am all mixed up here. I need to get 13485 as a basic quality system. Then I need to apply for CE Marking. The CE Marking as per MDR has more requirements than the CE marking under MDD. But article 61 (clinical investigations) of MDR allows an easier route for product extensions if you already have a CE under MDD for the basic range from the clinical investigation perspective.

I need clarity as to

1. If I get certification under ISO13485:2006, what do I need to comply with....MDR or MDD
2. If I apply for CE mark, what do I need to comply with

Sorry, I am new at this and trying to learn

The device is a class III device
 
Last edited:

Marcelo

Inactive Registered Visitor
#5
I am the first to admit that I am all mixed up here. I need to get 13485 as a basic quality system. Then I need to apply for CE Marking. The CE Marking as per MDR has more requirements than the CE marking under MDD. But article 61 (clinical investigations) of MDR allows an easier route for product extensions if you already have a CE under MDD for the basic range from the clinical investigation perspective.

Sorry, I am new at this and trying to learn

The device is a class III device
No problem, we have all been there. The good things is that you are trying to learn!

Regarding your questions, let me try to explain it to you in a quick way:

Basically, to comply with the MDD or MDR, you have to fulfill all the applicable requirements of the MDD or the MDR.

A generic, streamlined process to apply the CE is:

1 - Determine the applicable requirements from the regulations, in particular the essential requirements which apply to design and manufacturing (Annex I MDD, Annex I MDR).

2 - Apply all the applicable requirements to your design/manufacturing/QMS (you may use standards, any standard, to show that you fulfill the requirements. If you choose to use a harmonized standards, you gain something called "presumption of conformity. If you don't use a harmonized standard, you may have to take more steps to show why you comply with requirements. Standards, even harmonized standards, remains voluntary).

Another important aspect - QMS requirements in the MDD are only in the Annexes for each conformity assessment route (see below). In the MDR, general QMS requirements are in Article 10, and there's more requirements in the Annexes for each conformity assessment route.

3 - Depending on the risk class of your device, you may choose between different routes for the CE Marking - they are called Conformity assessment procedures in the MDD and MDR. They are in Article 11 in the MDD, and article 52 in the MDR.

Most of the routes require the involvement of a notified body.

The notified body will follow the requirements of the route chosen.

For example, Annex II in the MDD and Annex IX in the MDR details the requirements of the so called "full quality assurance" route. For those, the Annexes will detail the requirements to evaluate the QMS, technical documentation (design documentation) and surveillance. These are the requirements that will be evaluated.

4 - The notified will perform the evaluation, and after that will give you a certificate based on the route.

5 - You will finish and sign the declaration of conformity.

6 - Then you can put the CE marking in your products.

As I mentioned before, using EN 13485:2016, as it's a harmonized standard in the MDD, will give you presumption of conformity with several specific QMS requirements of the regulation, but not all requirements of the MDD are detailed in ISO 13485.

In the case of the MDR it's the same thing, but there are even some more requirements that are not detailed in ISO 13485. Also, there's no list of harmonized standards for the MDR yet because it's not on application right now (but EN ISO 13485:2016 will probably be harmonized with the MDR too in the future).

Well, that's it for now. If you have any other question, please feel free to ask.
 

Woodray

Starting to get Involved
#6
Okay, Now I get it. A big thank you my friend. It makes the picture clear. So I am going to focus on the harmonized standard 13485 and then look at the CE Mark and choose a route. I am a one man start up being brave by attempting a Class III product but quite a bit of the design, development and manufacture will be outsourced but I did like to do as much of it or at least be involved with most of it and have sufficient documentation to be able to be a manufacturer myself someday. Wish be luck on this very arduous journey. Thanks...Cheers
 

Marcelo

Inactive Registered Visitor
#8
Just another point - you mentioned article 61 (which is for clinical evaluation, not for clinical investigations). You may use paragraph 6 to not perform a clinical investigation (but please note that you still need to perform the clinical evaluation) if the device was put into the market using the MDD, but to put the device into the market using the MDD, you also need, besides performing the clinical evaluation which is always required, also perform a clinical investigation for a class III or implantable device. The only difference is that the MDD mentions that you don't need to perform the clinical investigation if there's a strong justification, and the MDR details a little more these options.

However, right now NBs are re3ally taking a revised and more stringent look at clinical investigations and clinical data, so you may take even need to perform a clinical investigation for the MDD anyway (which would be a problem, because you probably won't have the time to finish it before the MDR takes in).

All in all, I think you are in a somewhat bad timely position because of this transition period and reinforced evaluations (in particular in the case of Class III and implantable devices).
 

Woodray

Starting to get Involved
#9
You are right, timing isn't the best but a piggy back on some OEM manufacturer's clinical data might get me there especially if I get a market entry OEM product in class III and have product extensions thereon. Its all an adventure at this stage, something to do, maybe it might come right but I need to hurry along
Cheers
 
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