Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello Regulatory Experts,

I am looking for some thoughts relating to Article 120 of the MDR. We are making plans for our transition from MDD to MDR as a medical device manufacturer. We have multiple sites, Site A being our legal manufacturer address and Site B being a site which carries out purchasing/warehouse activities. We plan to move Site B in early/mid 2020. Site A will remain the same for years to come.

What I am considering is whether this relocation of Site B will require us to recertify all of our devices under MDR if this occurs after May 2020, given that the address change of Site B is listed on our MDD EC Certificate as a facility. If after May 2020 we move Site B, I presume our MDD EC Certificate would become invalid as the Site B address would be incorrect.

I understand the wording of Article 120 relates to significant changes to design or intended use of a device, but it seems unreasonable for any company to no longer be able to supply a device under MDD during the transitional period if such a facility change occurs. Such a change in site would be captured under a QMS audit.

Our current EC certificate expires in February 2020 and we plan to renew, but we are hoping to not have to recertify all of our devices under MDR with this change for obvious reasons!

Any thoughts, opinions or solutions would be greatly appreciated.

Thanks for your time.

Well in my own opinion a site change to manufacturing activities or a crucial supplier would be considered a significant change.  The Site B you describe if just doing purchasing (an administrative activity) and warehousing, changing this site in my opinion would not be a significant change.  Purchasing being an administrative type of function is a support function in the QMS processes that cross different areas.  Warehousing is only storing the product in conditions specified.  A significant change has to do with the actual manufacturing and final testing of the device having a potential impact on safety and performance of the finished device.  That is the key issue is impact a change either product or process may have on the General Safety and Performance Requirements, i.e. safety and performance.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-May-2019 17:08
From: Anonymous Member
Subject: Article 120 MDR - Change of Facility affecting MDD Certificate Validity

This message was posted by a user wishing to remain anonymous

​Hello Regulatory Experts,

I am looking for some thoughts relating to Article 120 of the MDR. We are making plans for our transition from MDD to MDR as a medical device manufacturer. We have multiple sites, Site A being our legal manufacturer address and Site B being a site which carries out purchasing/warehouse activities. We plan to move Site B in early/mid 2020. Site A will remain the same for years to come.

What I am considering is whether this relocation of Site B will require us to recertify all of our devices under MDR if this occurs after May 2020, given that the address change of Site B is listed on our MDD EC Certificate as a facility. If after May 2020 we move Site B, I presume our MDD EC Certificate would become invalid as the Site B address would be incorrect.

I understand the wording of Article 120 relates to significant changes to design or intended use of a device, but it seems unreasonable for any company to no longer be able to supply a device under MDD during the transitional period if such a facility change occurs. Such a change in site would be captured under a QMS audit.

Our current EC certificate expires in February 2020 and we plan to renew, but we are hoping to not have to recertify all of our devices under MDR with this change for obvious reasons!

Any thoughts, opinions or solutions would be greatly appreciated.

Thanks for your time.