MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies
- Home
- regulatory updates
- MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies
MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies
Regulatory Affairs Medical Devices In Vitro Diagnostics
Thursday, 27 June 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
On June 17th, 2024, the Medical Device Coordination Group (MDCG) released a new revision of the guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB) in the field of medical devices and/ or in vitro diagnostic medical devices and b) re-assessment of NBs (MDCG 2022-13 Revision 1).
Play
MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies
AI-generated audio
0:50
This guidance is intended for use by Designating Authorities and Joint Assessment Teams to assist them when conducting assessments of Conformity Assessment Bodies applying for designation as NB or when reassessing NB and now includes updates on the conduct of joint assessments relating to extending the scope of designations.
Get in touch with our experts
Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.
Discover more expert content
Previous
Regulatory Affairs
14 Oct 2024
MDCG 2024-12 released
It includes detailed sections on corrections, root cause analysis, corrective and preventive...
Regulatory Affairs
17 Dec 2025
Draft EU Implementing Act on Notified Body Procedure Published
The feedback period runs from 12 December 2025 to 23 January 2026. The draft regulation aims to...
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
17 Nov 2025
Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
The first call was launched on February 6th, 2025, and closed June 30th, 2025, but was only open to...
Regulatory Affairs
5 Mar 2025
Call for expression of interest in coordinated assessment of clinical investigations/performance studies
This pilot will allow sponsors to submit a single application for pilot coordinated assessments,...
Regulatory Affairs
14 Oct 2024
MDCG 2024-12 released
It includes detailed sections on corrections, root cause analysis, corrective and preventive...
Regulatory Affairs
17 Dec 2025
Draft EU Implementing Act on Notified Body Procedure Published
The feedback period runs from 12 December 2025 to 23 January 2026. The draft regulation aims to...
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
17 Nov 2025
Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
The first call was launched on February 6th, 2025, and closed June 30th, 2025, but was only open to...
Regulatory Affairs
5 Mar 2025
Call for expression of interest in coordinated assessment of clinical investigations/performance studies
This pilot will allow sponsors to submit a single application for pilot coordinated assessments,...
Regulatory Affairs
14 Oct 2024
MDCG 2024-12 released
It includes detailed sections on corrections, root cause analysis, corrective and preventive...
Regulatory Affairs
17 Dec 2025
Draft EU Implementing Act on Notified Body Procedure Published
The feedback period runs from 12 December 2025 to 23 January 2026. The draft regulation aims to...
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