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…
Why is the “Intended Purpose” important for medical devices under EU MDR?
What are the key differences between “Intended Use” and “Indications for Use” for medical devices?
What information should be included in statements regarding “Intended Purpose” or “Indications for Use”?
We explain the answers to these questions and lots more…
Intended Purpose, Intended Use and Indications for Use FAQ Read More »
What steps should be taken to prepare for compliance with EU MDR
How do you formulate a project plan?
How do you review Technical Documentation structure for EU MDR or IVDR?
We have the answers to these questions and 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.
What is a Gap Assessment?
How can it help?
What does it involve?
Read on to learn more…
Article 59 sets out how authorisation of CE Marking requirements derogation for medical devices (not IVDs) can be done. Clin-r+ provides guidance on Article 59 and CE mark derogation.
EU MDR Article 59 and CE Marking for Medical Devices Read More »
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