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.