Device name change and label color change EU requirement?

[sugizo521]

Hi All,

Our company is planning to change the trade name and label colour design of our device. Does this qualify as substantial change and require notified body assessment? A few information to help those that have experience in this and maybe can provide some answers to my question:
1. The supplier of the packaging materials including primary and secondary does not change, all supplier are ISO certified and have QMS in place
2. The specification of the packaging materials does not change
3. The label text does not change
4. The only change will be the trade name and colour design on device label, packaging and IFU

If this requires notified body assessment, what documents is required to be submitted to our NB?

Appreciation in advance for those that can help provide some insight and experience sharing.

Cheers,
S

 

[indubioush]

The label text is changing because your device name is changing.

Your notified body probably has a form that you will need to fill out. That form should guide you on the documentation to submit to them.

 

[Ronen E]

Basically it's a product line extension because the device name is (likely) its primary identifier, at least under the MDD. Might be a good idea to let the NB know (initially informally, e.g. an email); most likely they'll give you the nod and look at it in detail next time the come in, unless it's a higher risk device.

Normally design changes don't require NB notification (under the MDD) unless a Design Dossier was initially submitted for approval.

 

[sugizo521]

The label text is changing because your device name is changing.

Your notified body probably has a form that you will need to fill out. That form should guide you on the documentation to submit to them.

Thanks indubioush, I should have been clearer that what I meant by no change in content is referring to all other information listed on labelling and in the IFU. Apologies for not being clearer in the first place. I agree that this is considered changing in label text.

The application form the NB has just indicates submission of application form and verification report. However, there is no specific explanation on what the verification report needs to contain. Is this something that we can clarify with the NB by informing them what changes we are going to introduce to the device?

Thanks again for the response.

 

[sugizo521]

Basically it's a product line extension because the device name is (likely) its primary identifier, at least under the MDD. Might be a good idea to let the NB know (initially informally, e.g. an email); most likely they'll give you the nod and look at it in detail next time the come in, unless it's a higher risk device.

Normally design changes don't require NB notification (under the MDD) unless a Design Dossier was initially submitted for approval.

Thanks Ronen E, very helpful indeed.

our device is a Class III since it contains medicinal product as regulated by Directive 2001/83/EC. It is a gel based device with conformity assessment route via Annex II(4). I guess in our case the design dossier is submitted for the initial approval. Does this mean that we have to submit the entire design dossier again or just the parts that is affected by these changes?

Thanks!

 

[Ronen E]

Thanks Ronen E, very helpful indeed.

our device is a Class III since it contains medicinal product as regulated by Directive 2001/83/EC. It is a gel based device with conformity assessment route via Annex II(4). I guess in our case the design dossier is submitted for the initial approval. Does this mean that we have to submit the entire design dossier again or just the parts that is affected by these changes?

Thanks!

I would guess that only the parts affected, because it sounds like a straightforward change; but due to the higher class and conformity assessment route probably best to let the NB guide you.

 

[sugizo521]

I would guess that only the parts affected, because it sounds like a straightforward change; but due to the higher class and conformity assessment route probably best to let the NB guide you.

Thanks Ronen E! Appreciate the response and help