Regulatory Open Forum

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii 

Hi Oleksii,

in the sense of the IVDD and NBOG 2014-3 I would see these changes as not significant/substantial, because those would not only require the notification of the NB, but also a (prior) approval - which does not make sense here. The only possible exception would be if the discontinuation means a change in product range that would affect the scope of a QMS certificate.

With respect to Article 110 (MDCG 2022-6) I would think this is not a significant change in design or intended purpose.

However, aside from the legal requirements for approval (or no longer being a legacy device) you usually have contractual arrangements in place with your NB (or in the case of general IVDs with your certification body if you have an EN ISO 13485 certificate) that will usually require you to notify changes in your product list (usually updating an existing form), so that they can plan their sampling, reviewing and auditing activities accordingly. Especially if the discontinuation means a change in scope for a QMS certificate, this would need to be communicated to the NB/certification body.

So my slightly changed options would be:

General IVD - non-significant change (exception maybe: change in product range), notification to certification body in accordance with contractual obligation (and generally recommended)
AnneX II, List B - non-significant change, notification to NB in accordance with contractual obligations (and generally recommended).

Best regards,

Christoph

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii 

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii 

Hi Oleksii

Per the IVDD, 98/79/EC, Article 10, any discontinuation has to be notified. Per the IVDR, 2017/746, Annex VI, EUDAMED will be updated when a product is no longer available on the market. So I guess the NB expects to be informed.

I wonder if your NB contract mentions product discontinuations.

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii 

Good day Oleksii,

Since you are speaking about General IVD and List B, then no there would not need to be a notification for discontinuation of a product to the Notified Body.  But I completely agree with Christoph you may have to notify them anyway based on contractual arrangement.  If you have a List B product that is being discontinued, you would need to notify them that those product(s) would no longer be under scope of the certificate or you are withdrawing the Declaration of Conformity - thus the certificate would "stop" also.  In addition, there should be an "end of life" plan established for these products, because depending on the shelf-life/expiration date, the Notified Body may still be reviewing information, so helpful for the notification and when things with the product "stop" completely.

Since there is no Notified Body intervention under the EU IVDD for General List IVD, there is no obligation to a Notified Body.  Though again, if your quality system certificate encompasses certain processes or activities, this may need notification as well.  It is frustrating for an auditor to show up at the facility ready to do their audit, start asking questions about Product A, and the company says, "Oh yea, by the way, we stopped selling that product 8 months ago.  It is not in scope anymore."  This could have a significant impact on the audit agenda or planning of the auditor.

Hi Oleksii

Per the IVDD, 98/79/EC, Article 10, any discontinuation has to be notified. Per the IVDR, 2017/746, Annex VI, EUDAMED will be updated when a product is no longer available on the market. So I guess the NB expects to be informed.

I wonder if your NB contract mentions product discontinuations.

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii 

Hi Oleksii

Per the IVDD, 98/79/EC, Article 10, any discontinuation has to be notified. Per the IVDR, 2017/746, Annex VI, EUDAMED will be updated when a product is no longer available on the market. So I guess the NB expects to be informed.

I wonder if your NB contract mentions product discontinuations.

Hello All,

A company is not going to distribute several devices. We got a corresponding change request. General IVDs and Annex II, List B devices affected by this change. We use NBOG 2014-3 and MDCG 2022-6 to assess changes. I would appreciate any ideas about how discontinuation changes should be assessed. For example, we came up with several options:

1) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

2) General IVDs – significant change, notification to NB is not necessary

Annex II, List B – significant, NB is to be notified

3) General IVDs – non-significant change, notification to NB is not necessary

Annex II, List B – non-significant (as not impact on the safety and effectiveness), NB is to be notified

Please share your opinion on which option you support and why? 

Or, please suggest another option.

Regards,

Oleksii