Audit Under MDD

[nakab]

Hi, as of May 2024, we are still holding a legacy device for which the MDR application has already been submitted. Now, we would like to understand the audit requirements during this assessment period (tll certification). Do we still need to arrange an MDD audit with our NB, or will the surveillance audit ( stage 1, 2) under the MDR application would ensure our compliance within transition period (as the certification process could easliy take up to 150 working days for TUV)?

• In short, how will the current product be audited until we receive MDR (CE) certification? Thank you in advance for your clarification.

 

[EmiliaBedelia]

You will still be audited to MDD. In my experience the NB will just do 1 audit with both regulations (in our case, our audits include MDD, MDR, MDSAP, and ISO 13485). However this depends on how your notified body handles audits. An MDD audit will likely focus on Article 120 and compliance to the transitional requirements of MDR.

It's also worth noting that devices certified under MDD are still subject to desktop tech file audits , especially if an application has not yet been filed for MDR. So don't slack on your TF updates in the meantime

 

[Nichole F]

You will still be audited to MDD. In my experience the NB will just do 1 audit with both regulations (in our case, our audits include MDD, MDR, MDSAP, and ISO 13485). However this depends on how your notified body handles audits. An MDD audit will likely focus on Article 120 and compliance to the transitional requirements of MDR.

It's also worth noting that devices certified under MDD are still subject to desktop tech file audits , especially if an application has not yet been filed for MDR. So don't slack on your TF updates in the meantime

That was our experience as well. We also did the MDD/MDR/MDSAP/ISO 13485 audit. The MDD portion was either a half man day or a full man day. I don't recall which it was.

 

[nakab]

Thank you for the Replies. As per the current situation. We have submitted application of MDR. The stage 1 audit is already happening soon.