Clinical investigations of medical devices – guidance for manufacturers from the MHRA, covers everything from the choice to conduct a clinical trial to the approval process. CLIN-r+ gives you an overview and highlights key aspects to help you understand UK clinical investigation legislation if you plan to conduct one.
Medical device safety and performance can be demonstrated via clinical investigations. The Medical Device Coordination Group amended MDCG 2021-6 clinical investigation recommendations in December 2023. CLIN-r+ outlines both new and revised questions and answers.
Conformity routes under the clinical data needs for the EU MDR are not well understood and can lead to unnecessary costs due to investment into clinical investigations or unsuccessful CE assessments. CLIN-r+ outline the clinical evaluation route options, their requirements, and which devices they apply to.
Do manufacturers need to conduct investigations or follow an exemption route? CLIN-r+ explores the exceptions as outlined by MDCG 2023 and MDCG 2020-6.
The EU MDR has raised the bar for supporting data quantity and quality, so it is critical to keep the pace of preparation activities in Post-Market Clinical Follow-Up planning. This document provides manufacturers with best practice guidance for preparation, steps, and the three key pitfalls which CLIN-r+ frequently encounters.
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