Class I non-sterile, non-measuring: Requirements fulfiled?

M

mr.mike

#1
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.
 
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Peter Selvey

Staff member
Super Moderator
#2
Hi Mr. Mike,

First of all, although a little confusing the MDD is much more "readable" than most regulations, so just keep trying and it will start to make sense.

Under Article 11, you will find links between the Class of the device and the Annexes II ~ VII which outline declaration of conformity, required documents and notified body involvement. For a Class I, non-sterile, non-measurement device, the link is only to Annex VII (see Article 11, paragraph 5).

Annex VII is a self declaration and does not need notified body involvement, nor a quality system. The only need is to draw up the technical documents as outlined in that Annex.

Officially the format of the declaration of conformity should follow EN ISO/IEC 17050-1:2004, but as there some quirks with the MDD I recommend to search this forum for links to examples that I have seen before. One quirk is the declaration should refer to the "national transposition" of the medical device directive, another problem is that there are many standards for medical devices (not only IEC 60601-1) so best to link to a separate document in the technical file that lists all the applied standards including edition and amendments.

The competent authorities supervise the whole regulation. Generally you do not need to get involved with them unless there are incidents, or clinical trials or other serious matters, with the exception of registration under Article 14.

So, I recommend to read Article 11, 14 and Annex VII and then come back with more questions.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
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.
Hello and welcome to the cove :bigwave:

- For class I non-sterile non-measuring annex VII suffices, and annex II can be ignored. No need for NB.

- You can find good references for an EC DoC all over the web and probably in past threads here; anyway, the MDD is quite straightforward on this issue and if you follow its requirements your DoC will be fine. Once you have complied with the essential requirements and compiled the technical file, you should engage with an "EC representative" (see below), draw your EC DoC and submit it to your EC rep for registration with a competent authority.

- Class I devices need be registered with only one EC competent authority (could be MHRA but not necessarily). Such registration applies to the whole EC. The only exception I know is Italy, look for past threads here on this matter. Once you have engaged with one, your EC rep will apply for registration with the competent authority (typically the ministry of health) of their own member state. Please note you have to meet all applicable language (translation) requirements for the states your product will be distributed in.

- Being located outside the EC, you have to engage with an Authorized Representative ("EC rep"), which has an official place of business inside the EC. This representative will handle registration with the competent authority, and will also serve as the primary point of contact for the EC authorities, in case they have any concerns regarding your product.

Good luck,
Ronen.
 
S

SilverHawk

#4
It is now a requirement that your organization have to appointed an Authorized European Representative to list your Class I product. You may contact Obelis Belgium Email : [email protected] and log into their website www.obelis.net for further details
 
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