Auditor Comment about MDR vs MDD

[Ed Panek]

Our auditor commented that the scope of our internal audit for summer 2021 was ISO 13485 and MDR, although we are still approved under MDD. They mentioned that we should focus on both MDD AND MDR during this transition however I countered we received MDD approval in June of 2021 so we felt an MDD audit would not be valuable as we are transitioning to MDR within the next 12 months,

Do any MDR requirements conflict with MDD?

 

[vagabondbettie]

We are still under the scope of the MDD, however, during a remote audit two weeks ago, we were told we need to comply with MDR, Article 120 (3). Since then, I have confirmed this.

 

[Ed Panek]

Could one pass an MDR audit and fail an MDD audit? Which area(s) are most likely to cause an issue?

 

[shimonv]

This is so silly that you have to deal with such bureaucracy...
There is no direct conflict between MDD and MDR, just differences like reporting dates, PRRC, technical documentations structure, and PMS process. MDR is stricter than MDD.

I'm afraid it's difficult to work your way around this, even if you have a management review decision about transitioning to MDR.

-Shimon

 

[Ed Panek]

It was in Management Review that an objective of ours was a focus towards an application with our NB with MDR. Our goal was to at least apply in 2021, which we did. Now we have to justify the quotation price with revenue but that's another issue.

We wrote our annual quality plan stating we would move our QMS to be more MDR compliant in the meantime. One of the outputs of that was having our internal audit focus on MDR over MDD and using that audit result to drive CAPA to changes required. It feels ridiculous now that I should have asked us to be audited to BOTH MDD and MDR. MDD is much less risk-controlling than MDR so this seems counterintuitive and, as you said, beauracratic.

 

[shimonv]

it is... this soft of bureaucratic behavior keeps good and talented man away from the QA profession.
If the auditor is not reasonable you will just have to take a CAPA with no correction (based on a statement that MDR is stricter than MDD) and one corrective action - to keep MDD and MDR in the annual internal audit plan.

 

[TWA - not the airline]

13485 requires your quality management system to cover all regulatory requirements that are relevant for your company (based on products, markets, etc.), so formally MDD must be in the scope of your QMS and also in the scope of your internal audit. Per 13485 you'd then establish an audit plan with a risk based approach, so as you are preparing for MDR and MDR requirements are stricter and you have a good track record with MDD, there is no need to change more than this one line regarding the scope of the internal audit.

 

[Philip B]

We recently got a nonconformity for having our MDR procedures in draft, even though we are still under the MDD. I had to talk the auditor down from a major would you believe. This subject really riles me, there has been zero guidance on how to transition from MDD to MDR. I've asked two NB auditors recently on how to handle the transition (presumably at some point you have to make a batch break ie last batch made under MDD, first batch made under MDR) and both were clueless.

 

[Raisin picker]

Two points:
1) You do have to have several MDR procedures already active (especially PMS/PMCF and Vigilance). Others can wait until you submit for MDR certification. After all, MDR is the valid regulation for medical devices in Europe since May 2021 (nitpicking: since 2017, but grace periods were applied). You can sell devices with MDD certificate, but you have to be sure to cover all MDR aspects where there is no grace period any more.

2) Afaik, you can have a MDD certificate and a MDR certificate in parallel. So, you can decide when to make the batch break for the respective product. MDD and MDR do not contradict each other (in general).

 

[TWA - not the airline]

Some more comments:

- as raisin picker already pointed out, MDR currently is the valid regulation, so actually you should have an analysis, from when on you have to comply with which MDR requirement and how long which MDD requirements still apply to you and your product; strictly speaking only that would establish the real scope for your internal audit
- for passing the MDR audits I'd expect that you must be able to show you have performed at least one internal audit with the scope of MDR
- regarding transition of product, my MDD devices will not be same as the MDR ones, there is a required change to the labelling and that will clearly identify which is which as part of the change process