Internal Audits during the MDR Transition Period

lisasolo

Starting to get Involved
Hi! Wanted to get some feedback on how people are handling internal audits prior to undergoing an MDR conformity assessment.

We are starting the process of an MDR assessment with our notified body with the assessment likely occurring early-mid next year. We have already updated most of our QMS to the MDR in preparation for the NB assessment. We have an internal audit at the end of this year and were planning on doing the internal audit to the MDR instead of the MDD. However, our current certificate is under the MDD, so it creates confusion about what the scope of our internal audit should be during this transition period. Is it appropriate to do the internal audit to the MDR in anticipation of the conformity assessment happening so soon?
 

yodon

Leader
Super Moderator
This will probably be a wildly popular response. :) I would think you would want to do both. You still have product under the MDD so I think your NB will expect to see that the audit shows you're still in compliance with the directive. The MDR part wold be more of a preparedness audit
 

Cybel

Involved In Discussions
I agree with yodon. Before getting MDR certified, we updated our checklists adding MDR requirements and we made internal audits in compliance with both MDD (to verify compliance) and MDR (to check any gap, in the first place, and after to verify compliance before NB assessment).
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
We specifically requested to our consultant that they audit our QMS to 13485 AND MDR even though we are not yet MDR cleared. This was to create and identify gaps. the MDR is mostly a SUPERSET of the MDD so the risk is low on missing key areas.
 

Sinus Tarsi

Involved In Discussions
We did the same and are currently undergoing the internal audit for ISO and MDR. Our NB requires an MDD and MDR as long as we hold a valid certificate. Even though we aren't compliant to MDR as of yet, there are still MDR requirements that must be in affect and will be audited
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Around post-market stuff. Also, no substantial changes are reviewed under MDD any longer.
 
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