Change in address for critical supplier - does NB need to be informed?

[Ronen E]

Update for anyone reading: We contacted our notified body and they approved the change. The supplier will be re-audited and we would need to change all our technical data files and other internal documentations accordingly.

Thanks for updating! I suspected as much.

I'm not sure though what "they approved the change" means. I didn't think NBs have the power to "approve" significant changes under MDR transitional provisions for MDD legacy devices. In my understanding the only way to "approve the change" would be to go through the full-blast MDR certification, regardless of the existence of MDD certifications. Is that what's planned? "change all our technical data files and other internal documentations accordingly" (read: in full accordance with all applicable MDR requirements) seems to be in line with that. I hope you realise the magnitude/weight of this undertaking. I also hope your NB can (and actually will) fit your MDR certification in within a reasonable timeframe.

 

[EmiliaBedelia]

With respect to significant changes under the MDR transition: reference MDCG 2020-3. This guidance describes the types of changes that can be made under Article 120 of MDR (provisions for the transitional period).

From this guidance:
"Furthermore, all changes not having an impact on the design or the intended purpose of the device can be regarded as not significant in the meaning of MDR Article 120(3). This is the case for example of relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers, or of certain changes of the quality management system, provided that the conditions for which the conformity assessment certification was granted are maintained. Nevertheless, such changes continue to be subject to the agreed notification procedure identified in the first paragraph of the current section. The manufacturer should always remain responsible for providing evidence that all the above-mentioned changes do indeed neither affect the design nor the intended purpose."

From my understanding, the distinction here is that there are "substantial changes" per the 2014 NBOG guidance (ie, changes that are identified as substantial vs. non substantial as far as whether your NB needs to be notified), and there are "significant changes" under Article 120 (changes that are allowed to be made to MDD products under the MDR transition). These are 2 different things so while you may need to notify your NB about a change, if it's "not a significant change to design or intended use" under Article 120 you can still implement.

To answer OP's original question: Others have brought up process validation/verification for manufacturing site moves, but just to add on:
Part of the reason you need to provide critical subcontractors to your NB is because they will audit them. They need the contact info/address so that they can show up at that site and do an audit. If you know your NB has some information on file, it is probably a good idea to update that information if it changes.
Real life example: A company did not keep up with their subcontractor list. NB showed up at the contractor for an unannounced audit, contractor said "We haven't done anything for Company in years". NB was not happy about having their time wasted.

 

[Ronen E]

With respect to significant changes under the MDR transition: reference MDCG 2020-3. This guidance describes the types of changes that can be made under Article 120 of MDR (provisions for the transitional period).

From this guidance:
"... provided that the conditions for which the conformity assessment certification was granted are maintained. ..."

The last sentence is as clear as mud.

This is a fine example of the absurdity of MDCG guidance and its use by NBs as pseudo regulation. The NB has infinite power to interpret sentences such as the above in whichever way the choose to. That sentence could be equally rationalized to say that the referred conditions have irrefutably changed by the Contract Manufacturer moving site, or that they weren't really... What do those "conditions" include, or exclude?...

On a different aspect - IMO the NBOG substantial changes guidance is no longer applicable under the MDR (other than as a historical reference or indication of intent, where relevant).

 

[franklymissshankly]

Thanks for updating! I suspected as much.

I'm not sure though what "they approved the change" means. I didn't think NBs have the power to "approve" significant changes under MDR transitional provisions for MDD legacy devices. In my understanding the only way to "approve the change" would be to go through the full-blast MDR certification, regardless of the existence of MDD certifications. Is that what's planned? "change all our technical data files and other internal documentations accordingly" (read: in full accordance with all applicable MDR requirements) seems to be in line with that. I hope you realise the magnitude/weight of this undertaking. I also hope your NB can (and actually will) fit your MDR certification in within a reasonable timeframe.

We are indeed going for an MDR certification with the said notified body as the next step. The company signed a major agreement with an EU distributor so that was a requirement. We definitely realize the gravity of that- I believe we will hire consultants to figure out MDR. The rest of our team does not have much experience with the EU.

I am unsure why this change did not trigger the NB negatively. They asked us to provide documentation on why the site needed to change (critical supplier's site was ordered to be demolished by their government) and that seemed to work.

 

[EmiliaBedelia]

The last sentence is as clear as mud.

This is a fine example of the absurdity of MDCG guidance and its use by NBs as pseudo regulation. The NB has infinite power to interpret sentences such as the above in whichever way the choose to. That sentence could be equally rationalized to say that the referred conditions have irrefutably changed by the Contract Manufacturer moving site, or that they weren't really... What do those "conditions" include, or exclude?...

Is "significant change to the design or intended use" as stated in Article 120 that much clearer, though? They already have infinite power to interpret that however they want as well. "Design change" could be interpreted narrowly (eg, if the drawing is not updated, it's not a design change) or extremely broadly (eg, anything that could impact the final device is part of the design). "Significant" is very much in the eye of the beholder, and seems to be even more open to interpretation. I'm not trying to defend MDCG guidance on the whole, but this is definitely an area where the regulation is not clear, and as a manufacturer I think the 2020-3 guidance is more helpful than not.

When notifying a change to the NB, isn't it always the goal to justify why the change does or does not impact the final device, and thereby explain how "the conditions for which conformity assessment certification was granted are maintained"? If a notified body rejects a change because the aforementioned "conditions" weren't "maintained", they probably would reject it for being "significant" as well.

On a different aspect - IMO the NBOG substantial changes guidance is no longer applicable under the MDR (other than as a historical reference or indication of intent, where relevant).

If a device is still under MDD, I would think it is still applicable to use the NBOG guidance in conjunction with Article 120 to assess changes. For an MDR device, I'd agree that it's out of date.

 

[optomist1]

when in doubt, esp. re: critical supplier and to be for sure, for sure, perform an onsite audit...boots on the ground are best!! Remote visits pose their own challenges...

Hope this helps...

optomist1

 

[Ronen E]

Is "significant change to the design or intended use" as stated in Article 120 that much clearer, though? They already have infinite power to interpret that however they want as well. "Design change" could be interpreted narrowly (eg, if the drawing is not updated, it's not a design change) or extremely broadly (eg, anything that could impact the final device is part of the design). "Significant" is very much in the eye of the beholder, and seems to be even more open to interpretation. I'm not trying to defend MDCG guidance on the whole, but this is definitely an area where the regulation is not clear, and as a manufacturer I think the 2020-3 guidance is more helpful than not.

When notifying a change to the NB, isn't it always the goal to justify why the change does or does not impact the final device, and thereby explain how "the conditions for which conformity assessment certification was granted are maintained"? If a notified body rejects a change because the aforementioned "conditions" weren't "maintained", they probably would reject it for being "significant" as well.

I very much agree with you - well spoken. Yes, at the moment MDCG guidance is probably the best we have, and we have to work with it... The regulation is indeed sometimes vague (even very vague in some instances) - this is probably because of the enormity of the undertaking to get it initially over the line, and the "impossible" politics around it. The release of the MDR in 2017 was sort of a miracle, haha. A better way to deal with those ambiguities, however, is either by amending the regulation (apparently more difficult legally) or by issuing Implementing Acts, which would/could elaborate and disambiguate what terms like "significant" (or another pet peeve - "critical") mean in specific contexts. Sadly, neither happen very often.

If a device is still under MDD, I would think it is still applicable to use the NBOG guidance in conjunction with Article 120 to assess changes. For an MDR device, I'd agree that it's out of date.

Strictly speaking, no devices are under the MDD anymore, because the MDD was repealed. Legacy devices (with certificates issued under the MDD) that are currently under MDR Article 120 are not supposed to undergo "significant changes" at all under that Article, and I think the MDCG guidance provides all the clarity we can realistically expect from NBs in this context, so I don't see a reason why the NBOG document would still be applicable.

On the other hand, I can definitely imagine NB staff happily including it in any related discussion, regardless... It seems that strict "legal" thinking is pretty much on the way out in this field, and people are happy wading in the warm, grey swamp of pseudo legal. From a project management perspective, the implementation of the MDR by EU bodies has been a disaster (some say a predictable one), and it seems that wherever anything is still missing - >2 years after the original DoA - the default is to fall back onto the remnants of the old system (whose flaws are what triggered the MDR creation, in case anyone forgot).

 

[RegulatoryUS_EU]

Hi all,

if a new indication is added (e.g. new type of wound) to the existing and approved (under MDR) intended use of a device, my understanding is that we should notify the notified body since this is a significant change. Then, my assumption is that this will trigger an addendum or a new certificate for the addtion of this new indication. Is this correct?

also, if a new certificate/addendum should be issued, do we have to go through the whole NB evaluation procedure? or is there an expedited pathway since the device was alreadyc ertified under the MDR?

thanks in advance!

 

[Raisin picker]

Afaik, that's up to the NB. They will consider your change request and decide wheter to approve it directly, evaluate the change request itself* (by an expert) or evaluate the whole documentation. This depends, of course, on the type of change. Adding a second source for some supply might get approved quickly, a change in the production process would be assessed by a technical expert, while adding a new indication most likely will require an assessment of the clinical evaluation by a clinical expert.

*it is helpful to provide a rationale for the change that covers all the relevant aspects. Describe and submit all documents affected by the change (DoC?, SSCP?, RM?, CER?, ...).

 

[Ronen E]

Hi all,

if a new indication is added (e.g. new type of wound) to the existing and approved (under MDR) intended use of a device, my understanding is that we should notify the notified body since this is a significant change. Then, my assumption is that this will trigger an addendum or a new certificate for the addtion of this new indication. Is this correct?

also, if a new certificate/addendum should be issued, do we have to go through the whole NB evaluation procedure? or is there an expedited pathway since the device was alreadyc ertified under the MDR?

thanks in advance!

From MDR Annex VII (emphasis added):

4.9. Changes and modifications
The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to:
[...]
— the intended use of or claims made for the device,
[...]
and being subject to the specific procedures in accordance with Section 4.5.6 [i.e. the NB role in conformity assessments].
The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph.
In accordance with its documented procedures, the notified body in question shall:
— ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes,
— assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation, and
— notify the manufacturer of its decision and provide a report or as applicable a supplementary report, which shall contain the justified conclusions of its assessment.