Hello Anon,
In application you would create the GSPR when you are transitioning your entire Technical Documentation for compliance to the EU MDR. As the GSPR is "part of" the overall technical documentation, when updating to be ready for a Notified Body review or just updating, you would generate the GSPR then. If your current certificate goes out to 2024, then just update your GSPR when you update all the other documentation and ready for your Notified Body review.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-Nov-2020 09:28
From: Dan O'Leary
Subject: GSPR
A device can be in one of three states:
Full MDD
MDD as modified by MDR Article 120
Full MDR
If the device is part of your Article 120 transition, then the applicable technical documentation includes MDD Annex I. The device must stay compliant will the MDD and you can't make any significant changes to the design or intended purpose.
When you implement full MDR, then the technical documentation includes MDR Annex I. The device must comply with the MDR.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 30-Nov-2020 08:52
From: Anonymous Member
Subject: GSPR
This message was posted by a user wishing to remain anonymous
Hello,
Our MDD Certificate is valid until 2024, however do we still need to transition our ER Checklist to GSPR Summary by May 2021? I appreciate any feedback.
Thank you