Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?

Question

Our company has a device certified under the MDD with a certified QMS (quality management system). We are planning to transition to MDR certification.
Do we need to undergo a new QMS audit according to MDR, or is it sufficient to update and submit our technical documentation to our notified body? Specifically, does an existing MDD or ISO 13485 QMS audit meet the MDR requirements, or is a new audit mandatory?

Dr. Oliver Eidel · Accepted Answer

For our company, the stage I audit was a verification of our QMS specifically against MDR requirements, and then we sent in our technical documentation for review and CE marking. So, yes, you will likely receive a QMS audit because the QMS requirements under MDR are more specific and stricter than under MDD, like reporting timelines. Basically, a new audit is expected.

Answer

What conformity assessment do you have? If you have at least class IIa you also need to have a certified QMS.

Answer

We have a certified QMS, and I asked a similar question. It seems best to check with your notified body. In our case, the notified body said the MDR audit is more strict for the QMS, so if we decide to market an MDR compliant device, we need a longer audit than just a surveillance audit.

Answer

I discussed this with our notified body. Neither a MDD nor a ISO 13485 QMS audit can formally be used for MDR QMS. The conformity assessment procedure for MDR that needs a certified QMS must be based on its own audit. For example, our company was quoted three days for ISO 13485 audit, but five days for MDR QMS, so MDR is more detailed. It’s always good to double check with your notified body though.

Answer

Some notified bodies use the MDR as a reason for a new certification, but our notified body didn’t mention anything about that. We wanted to change notified bodies, but the new one did not accept the QMS certificate, so it would need a new QMS certification. Since ISO 13485 is harmonized, it should be okay with MDR. QMS is audited annually and, together with the technical documentation, there will be an on-site audit, but I don’t think an NB will make a complete new first certification except for the three-year re-certification.

Answer

From our experience, some notified bodies treat the transition to MDR as a requirement for a new QMS audit, while others may be more flexible, especially if your ISO 13485 is up to date. It’s best to check directly with your notified body, as practices seem to differ.

Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?

6 Answers

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