How to manage the QMS system and SOP during the transition from MDD to MDR

[alag]

Hello-
new to the group. I hope I am doing everything correct for my first post .
Just curious to know how manufactures in the transition process from MDD to MDR are currently processes their SOPs in their QMS systems. Are you keeping both MDD and MDR SOPs live at the same time? or are you still releasing SOPs in alignment to MDR even if you haven't got the certification yet? thanks a lot

 

[yodon]

Welcome and congrats on your first post.

I don't think there's anything in the MDR that would be contradictory / counter to anything in the MDD so I don't see any issue with (incrementally) advancing your SOPs.

 

[alag]

Hi Yodon,
Thanks for your reply.
I agree with you comments, there are however differences like ERs for MDD and GSPR for MDR or for example additional requirements in the DoC. These templates require an update and at the same we should be kept valid until the MDR certification.
Therefore I was just curious to see how they were managed in the QMS during the transition. thanks

 

[DMLqms]

I'm in the same place as you - I'm going to have both ERCs and GSPRs for each technical file at least for now and amend my procedures as I go.

 

[alag]

I'm in the same place as you - I'm going to have both ERCs and GSPRs for each technical file at least for now and amend my procedures as I go.

same thing here. make sense keep them both active in the transition period. thanks

 

[StepPCHen]

Hi Guys,

I had identified SOPs etc to be revised for MDR compliance as part of my MDD to MDR Roadmap. I had revised a handful of SOPs to swap out MDD for MDR, going through an MDD/13485/9001 surveillance audit last month I picked up an NCR for this. The auditor's rationale was that we were not being audited to MDR and should not reference it.

I showed them the roadmap and transition timeline, pointed to Article 10 of MDR but he was not having any of it.

CAPA for NCR included a revision of SOPs and include MDD reference alongside MDR reference, this was accepted as a close out.

 

[Ed Panek]

Hi Guys,

I had identified SOPs etc to be revised for MDR compliance as part of my MDD to MDR Roadmap. I had revised a handful of SOPs to swap out MDD for MDR, going through an MDD/13485/9001 surveillance audit last month I picked up an NCR for this. The auditor's rationale was that we were not being audited to MDR and should not reference it.

I showed them the roadmap and transition timeline, pointed to Article 10 of MDR but he was not having any of it.

CAPA for NCR included a revision of SOPs and include MDD reference alongside MDR reference, this was accepted as a close out.

Much of MDD still exists in the MDR. I would be curious specifically what in MDR isn't covering that exact requirement from MDD?

 

[Steve_in_MT]

I had the same thing happen with my last Tech File review to the MDD--rather than updating the Essential Requirements I had replaced them with the GSPR, thinking I was ahead of the game and that the GSPR would contain everything in the ERs and then some. The auditor wouldn't accept them since he said we were still being audited to the MDD.

Something I have says that starting May 26, 2021, even if you're still under the MDD, the following must be in place and fulfill the MDR requirements: "PMS, market surveillance, vigilance, registration of economic operators and of devices." It also says that during the grace period (transition) there can be no significant changes in design and intended uses, and that the UDI requirements must be met once the database is set up.

Anyone know of anything else that is needed?

 

[StepPCHen]

Hi Steve,

I believe Article 10 of the MDR will tell you what you need to do for the QMS; change control, PMS, UDI, EUDAMED, PRRC to name a few

 

[Raisin picker]

What I've seen so far was to address both regulatons in parallel. The contents do not contradict each other, but many things have new names, e.g essential requirements according to MDD and general safety and performance requirements according to MDR.
This can be done during transition, instead of replacing the MDD reference, you add the MDR reference to it. Worked for me so far, but I'm only aware of this in the clinical evaluation field.