Second revision to MDCG 2023-3 Guidance document released
Second revision to MDCG 2023-3 Guidance document released
Regulatory Affairs Medical Devices In Vitro Diagnostics
Monday, 27 January 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
On January 7th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance document containing Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This second revision of MDCG 2023-3 contains minor clarifications when compared to the first revision.
Second revision to MDCG 2023-3 Guidance document released | QbD Group
1:20
What is updated in MDCG 2023-3 Rev. 2:
In explaining the difference between incidents and serious incidents, the reporting obligations of manufacturers are updated to align with the current gradual roll-out of Eudamed.
Reference to ‘Eudamed vigilance module’ is corrected to ‘Eudamed Post-market surveillance and Vigilance module’.
The review and commenting period for a competent authority upon receiving a draft Field Safety Notice is clarified to be 2 weekdays.
What does it mean to you?
MDCG 2023-3 Rev.2 is important for all MD and IVD manufacturers that place products on the EU market: they have to comply with the vigilance obligations from MDR respectively IVDR. Establishing a good understanding of vigilance terms and concepts is important to effectively implement the vigilance requirements under these Regulations.
Discover more expert content
Previous
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
10 Jan 2025
New MDCG 2020-16 Revision 3 Guidance Documents Released
MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices...
Regulatory Affairs
27 Jan 2025
New revisions of the Preliminary Assessment Review templates, forms and annexes
The documents are available in the Notified Body section of the MDCG Guidance webpage. The...
Regulatory Affairs
5 Mar 2025
Fifth revision to MDCG 2019-6 Guidance document released
MDCG 2019-6 Rev. 5: Questions and Answers on requirements relating to notified bodies.
Regulatory Affairs
23 Apr 2025
New Revision to MDCG 2020-16 Guidenance Document Released
This fourth revision of MDCG 2020-16 focuses on devices to detect infectious agents, and in...
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
10 Jan 2025
New MDCG 2020-16 Revision 3 Guidance Documents Released
MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices...
Regulatory Affairs
27 Jan 2025
New revisions of the Preliminary Assessment Review templates, forms and annexes
The documents are available in the Notified Body section of the MDCG Guidance webpage. The...
Regulatory Affairs
5 Mar 2025
Fifth revision to MDCG 2019-6 Guidance document released
MDCG 2019-6 Rev. 5: Questions and Answers on requirements relating to notified bodies.
Regulatory Affairs
23 Apr 2025
New Revision to MDCG 2020-16 Guidenance Document Released
This fourth revision of MDCG 2020-16 focuses on devices to detect infectious agents, and in...
Regulatory Affairs
23 Dec 2024
Revision of MDCG 2019-13 released
MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C...
Regulatory Affairs
10 Jan 2025
New MDCG 2020-16 Revision 3 Guidance Documents Released
MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices...
Next
- 1
- 2
- 3
Stay ahead in life sciences
Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.
Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.
Twitter Widget Iframe