New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices
- Home
- regulatory updates
- New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices
New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices
Monday, 22 April 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices under Regulation (EU) 2017/745 or the medical device regulation (MDR) (MDCG 2024-5).
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chapter I of Annex XV of the MDR which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated. This includes the intended purpose(s), design, the basic fundamental scientific principles behind the design and the level of objective evidence already in place, to assure its safety and functionality during the investigation.
This guidance document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.
In the absence of a dedicated guidance document for the IB that is also required as per Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for interventional clinical performance studies and certain other performance studies, this guidance can be used as reference what is to be expected for these studies.
What Does This Mean To You?
MDCG 2024-5 is of relevance for all parties that are involved in clinical investigations of medical device devices.
Need regulatory support?
Trust our expertise to guide you through the regulatory process and achieve compliance
with ease.
Discover how we can help.
Discover more expert content
Previous
Regulatory Affairs
9 Dec 2024
New MDCG Guidance document released
On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the...
Regulatory Affairs
12 Dec 2024
New MDCG 2024-16 form released
On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer...
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
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
15 Mar 2024
New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies
New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan...
Regulatory Affairs
9 Dec 2024
New MDCG Guidance document released
On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the...
Regulatory Affairs
12 Dec 2024
New MDCG 2024-16 form released
On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer...
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
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
15 Mar 2024
New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies
New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan...
Regulatory Affairs
9 Dec 2024
New MDCG Guidance document released
On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the...
Regulatory Affairs
12 Dec 2024
New MDCG 2024-16 form released
On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer...
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