EU Medical Device Change Decision Tree (when to notify the NB)

Hi

I am new to the forum and this is my first thread.

Does any one have a decision tree document that helps to identify when to notify a notified body for a design change to a CE marked product already in the market and when to notify a notified body for a quality system change.

How do I decide upon what is a substantial change and a non-substantial change??

Thank you!

Raval1 said:

Hi

I am new to the forum and this is my first thread.

Does any one have a decision tree document that helps to identify when to notify a notified body for a design change to a CE marked product already in the market and when to notify a notified body for a quality system change.

How do I decide upon what is a substantial change and a non-substantial change??

Thank you!

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Hello and welcome to the cove

Actually it's quite simple: When in doubt - ask.

Notified bodies are not identical to each other. Each one has its own style, policies and practices, and that's just fine, because as you probably know, the regulation has some grey areas and room for interpretaion. So sometimes it's just best (and easiest) to consult with your actual NB. I think that's one of the reasons they're there in the first place.

I would recommend developing an informal communication channel with your NB, if you don't already have one. Once you sorted out your issue via the informal channel, you can formally "notify" them, if that would still be required. I believe after several such runs, you'll start to get a good feel about when you are/aren't required to formally notify, and you'll need that prior informal consultation less and less.

Cheers,
Ronen.

Many thanks fellow Cover!

There is an old NB-MED/2.5.2/Rec2 which details what the Notified Bodies would like to have reported. However (a) this document was never ratified by the EU commission, (b) contains several points that conflict with the MDD itself, and (c) seems to deliberately mix Annex II, III etc together to create the impression that everything needs to be reported.

However there is a newer series of guidance (NBOG) which are approved by the EU commission. For technical files, Section 9 of the guidance simply states:

Manufacturers introducing a new subcategory of Class IIa device or a new generic Class IIb device need to inform their NB who need to review relevant technical documentation prior to the products being placed on the market.

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The terms "device subcategory" and "generic device group" are defined in the MDD itself, see Article 1, Section 2 items (l) and (m).

For quality systems, there is no official guidance from EU. However, ISO-IEC Guide 17021:2006 which Notified Bodies should be using states:

8.6.3 Notice of changes by a client

The certification body shall have legally enforceable arrangements to ensure that the certified client informs the certification body, without delay, of matters that may affect the capability of the management system to continue to fulfil the requirements of the standard used for certification. These include, for example, changes relating to:

a) the legal, commercial, organizational status or ownership,
b) organization and management (e.g. key managerial, decision-making or technical staff),
c) contact address and sites,
d) scope of operations under the certified management system, and
e) major changes to the management system and processes.

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If you Notified Body requires different reporting requirements I would challenge them using the above references.

However, note that there is always a risk that design changes may result in non-conformities in the following audit, which in extreme cases could result in market recall (especially for Class IIb devices). You can limit this risk by applying for a voluntary review of these changes. In such a case, the Notified Body should charge for the review and provide a report.

... Perhaps this will assist you.