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:
- 2024-1-1 for cardiac ablation
- 2024-1-2 for coronary stents
- 2024-1-3 for cardiac implantable electronic devices (CIEDs), and
- 2024-1-4 for breast implants.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 12-Feb-2024 18:37
From: Armin Beck
Subject: MDCG 2024-1
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.
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Armin Beck
CEO
SunTrixConsulting LLC
El Dorado Hills, CA
1-925-212-7683
armin.beck@suntrixmedical.com
Original Message:
Sent: 12-Feb-2024 12:47
From: Anonymous Member
Subject: MDCG 2024-1
This message was posted by a user wishing to remain anonymous
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?