M
Hi Everyone,
Could use a bit of guidance regarding the sale of a Class I, non-sterile, non-measuring device in Europe.
Our company has the following:
- CE marking (with a CB test-report)
- A completed Technical File for the device
- We meet the Essential Requirements for our device as per MDD Annex I
What I'd like to clarify is the following:
- Do we need a Notified Body? (given Class I non-sterile, non-measuring). As far as I gather, we do not. However, according to section 3.1 of Annex II, we must lodge an application for Quality System assessment with a NB?
- I presume that our next step is a EC Declaration of Conformity? Does anyone have a link to a good guideline for drawing up such a document? Also, when completed, where does this declaration document get submitted?
- Are there additional regional requirements? For example, is registration with the MHRA necessary to sell in the UK?
- Also, probably relevant is the fact that we are NOT based in Europe. Does this impose any additional requirements?
Finally, I'm confused by the term "Competent Authority" which is used often in the MDD. Is this an additional service we will have to pay for?
I know this is a lot of questions, and please forgive me if I've overlooked anything obvious. Any links, guidelines, or references to relevant threads is greatly appreciated.
Thanks in advance,
MM.
Could use a bit of guidance regarding the sale of a Class I, non-sterile, non-measuring device in Europe.
Our company has the following:
- CE marking (with a CB test-report)
- A completed Technical File for the device
- We meet the Essential Requirements for our device as per MDD Annex I
What I'd like to clarify is the following:
- Do we need a Notified Body? (given Class I non-sterile, non-measuring). As far as I gather, we do not. However, according to section 3.1 of Annex II, we must lodge an application for Quality System assessment with a NB?
- I presume that our next step is a EC Declaration of Conformity? Does anyone have a link to a good guideline for drawing up such a document? Also, when completed, where does this declaration document get submitted?
- Are there additional regional requirements? For example, is registration with the MHRA necessary to sell in the UK?
- Also, probably relevant is the fact that we are NOT based in Europe. Does this impose any additional requirements?
Finally, I'm confused by the term "Competent Authority" which is used often in the MDD. Is this an additional service we will have to pay for?
I know this is a lot of questions, and please forgive me if I've overlooked anything obvious. Any links, guidelines, or references to relevant threads is greatly appreciated.
Thanks in advance,
MM.
