Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices.
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.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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