Regulatory Open Forum

Hello All, 

We are preparing for our Stage 1 EU MDR Audit, and I was hoping someone would be willing to share some insight into what we can expect. I have an Audit Plan from my NB and am using ANNEX IX from the Regulation as my checklist, but I wanted to get some real-world feedback if possible; I know every NB and auditor is different. For reference, we manufacture and design Class IIa devices that were not previously considered medical under the MDD, so this will be our first "European" audit. We are ISO 13485, and MDSAP Certified though.  

Thank you in advance!

Hello Rebecca,

In the past Stage 1 audits used to be done completely remotely and was really just a document review.  The Notified Body (and/or Certification Body) requested a number of documents such as procedures, instructions, and maybe some sampling of records.  Nowadays because when the Notified Body showed up for the Stage 2 audit they saw the procedures were written, but not implemented, this slowly transitioned over the years to doing Stage 1 audit either part remote review with some onsite time or completely onsite.  The intent of a Stage 1 is really to examine the overall system from a high-level, doing some interviewing, and assure the Stage 2 would go smoothly or more smooth.  Stage 1 is also usually limited being 1 or 2 days compared to the Stage 2 audit which may be 3 to 5 days in length.  If this is also EU MDR focus, then it will focus on those areas of Article 10 and Annex IX.  It also depends on if the Technical Documentation will be reviewed in conjunction either at the same time or close together.  You are right it does vary depending on the Notified Body and auditor, so if you say at least the NB maybe some others might give some recent experience with their Stage 1.

Hello All, 

We are preparing for our Stage 1 EU MDR Audit, and I was hoping someone would be willing to share some insight into what we can expect. I have an Audit Plan from my NB and am using ANNEX IX from the Regulation as my checklist, but I wanted to get some real-world feedback if possible; I know every NB and auditor is different. For reference, we manufacture and design Class IIa devices that were not previously considered medical under the MDD, so this will be our first "European" audit. We are ISO 13485, and MDSAP Certified though.  

Thank you in advance!