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Clinical Investigation of Medical Devices
What is Clinical Investigation?
Clinical Investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Why is Clinical Investigation important?
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in EU MDR 2017/745 Regulation should be based on clinical data that, for Class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor.
What is Clinical Investigation Plan?
Clinical Investigation means a document that describes the rationale, objectives, design, methodology, statistical considerations, organization, and conduct of a clinical investigation.
As part of Clinical Investigation process, the Clinical Investigation Plan will be prepared.
Adverse Events (AE) Reporting
Another important term related to the Clinical Investigation process that one has to be aware of is serious Adverse Events (AE) reporting.
According to Reg. 2017/745, serious adverse events, device deficiency that could lead to an adverse event, and its follow-up must be reported via the internet portal. It includes adverse events that could lead to death, serious conditions of ill-health of the subject, foetal distress and/ or death, congenital anomaly or birth defect.
How can we help?
The experts of CECD aim at the following six main points of direct practical relevance while involving in design and conducting a Clinical Investigation:
Role of Clinical Investigations in the context of clinical evaluation of Medical Device
Objectives of Clinical Investigation
Cases where a Clinical Investigation is mandatory and exceptions to this rule
Application procedure for a Clinical Investigation
Requirements for conducting a Clinical Investigation
Serious Adverse Events (AE) reporting
Clinical Investigation results
CECD team does the complete clinical investigation for you and prepare adequate documents such as Clinical Investigation Plan as part of Clinical Investigation results.
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