I always find the term "legacy product" confusing, because with the EU-MDR you start over. However, for products with a CE Mark under the MDD, you may have some of the data required by the EU-MDR.
In terms of the SSCP, it is required for device registration. See Annex VI, Part A, section 2.14. However you will not load it to Eudamed, the NB does that.
You will apply to an NB, probably following Annex IX. Part of your application will include the draft SSCP. The NB will review it and, if it is satisfactory, the NB will put it into Eudamed. You will reference the Eudamed location in your IFU or some other suitable place.
You will need to understand the NB's requirements for language for the draft version. The version in Eudamed will need to be in multiple languages, so, after approval, the NB will probably ask you for all the translations. This will allow the NB to post all of them.
For the manufacturer, Eudamed availability is not a consideration.
During surveillance audits, the NB will determine if you have updated the SSCP when required. They will also know if you have submitted drafts of the updates for their review and posting on Eudamed.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 14-Aug-2019 16:23
From: Anonymous Member
Subject: MDR Article 32 -SSCP / Legacy devices
This message was posted by a user wishing to remain anonymous
Dear All
Article 32 indicates
"The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body."
This SSCP shall be updated at least annually by Article 61.
My questions:
- For legacy devices, should this SSCP draft be submitted by first time once EUDAMED is ready? or
- should this SSCP draft be ready for recertification?
Thank you!