I have a question in regard to recently released MDCG 2024-1, Guidance on the vigilance system for CE-marked devices DSVG 00 Device Specific Vigilance Guidance(DSVG) Template. Does anyone have any idea what this document is referring to? What is a Specific Device, that the guidance repeatedly refers to?
The term specific device is very broad, and the meaning is that different devices have different reporting requirements. As an example: Implants vs class I no sterile. You need apply the guidance in accordance with your specific device.
MDCG 2024-1 is simply a template to be used by the MDCG when it writes and issues device specific vigilance guidance (DSVG) documents. Thus, in 2024-1, "Specific Device" is just a place holder to be filled in with the actual type of specific device when the template is used to create a particular DSVG. Thus far, the MDCG has released four DSVGs using the 2024-1 template:
What Kevin says: This is a template for the MDCG, the guidances of interest for the manufacturer are the ones where the "specific device" has been filled in with a particular device/device type. This is the same approach that was used under MEDDEV 2.12/1 (with almost identical specific guidances).
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