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.
Before CE registration, medical device classification is crucial. Classification affects the device’s regulatory requirements, approval route, and expenditures. Manufacturers are responsible for the correct classification of their device(s). CLIN-r+ has created this paper to give an overview of the process.
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.
What are common nonconformities identified under the EU MDR?
What does a Notified Body want from your Technical Documentation?
What can mitigate risks and ensure compliance?
We have these answers and much more…
Feedback from MDR regulatory submissions are valuable assets that we incorporate in our EU MDR transition projects and strategy documents for clients. CLIN-r+ shares the evolving collective expert knowledge to support you in your MDR submissions.
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