New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies
- Home
- regulatory updates
- New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies
New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies
Friday, 15 March 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices.
On March 12th, 2024, the Medical Device Coordination Group (MDCG) released guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices according to article 70(1) of Regulation (EU) 2017/745 or the Medical Device Regulation to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. (MDCG 2024-03).
This guidance document, which is developed by contribution from national competent authorities, industry and relevant stakeholders can be recognized as best practice and should support the sponsors of those clinical investigation plans (CIP) as it describes in great detail what type of information is needed in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. The CIPs should be adapted based on the type of clinical investigation and type of development stage of the investigational medical device. Last, for combined studies of medical devices and pharmaceutical products, legal requirements from several regulations should be addressed for which the structure and content of the CIP may need to be adapted. However, sponsors need to be aware that the elements required by MDR need to be present in a combined CIP/study protocol, and this guidance is intended to be useful also in those situations.
What Does This Mean To You?
MDCG 2024-03 provides guidance on the content of the clinical investigation plan (CIP) for medical devices and as such provides valuable insights for all sponsors of those studies or other parties that are involved in the investigation of medical devices.
Discover more expert content
Previous
Regulatory Affairs
15 Nov 2024
MDCG 2023-3 Rev 1 released
On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision...
Regulatory Affairs
6 Nov 2024
MDCG 2024-13 and MDCG 2022-5 Rev 1 released
On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG...
Regulatory Affairs
22 Apr 2024
New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released
On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document...
Regulatory Affairs
27 May 2024
New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies
On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body...
Regulatory Affairs
15 Mar 2024
New MDCG Guidance Released: Device-Specific Vigilance Document
The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document...
Regulatory Affairs
15 Nov 2024
MDCG 2023-3 Rev 1 released
On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision...
Regulatory Affairs
6 Nov 2024
MDCG 2024-13 and MDCG 2022-5 Rev 1 released
On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG...
Regulatory Affairs
22 Apr 2024
New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released
On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document...
Regulatory Affairs
27 May 2024
New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies
On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body...
Regulatory Affairs
15 Mar 2024
New MDCG Guidance Released: Device-Specific Vigilance Document
The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document...
Regulatory Affairs
15 Nov 2024
MDCG 2023-3 Rev 1 released
On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision...
Regulatory Affairs
6 Nov 2024
MDCG 2024-13 and MDCG 2022-5 Rev 1 released
On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG...
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