What is included in a clinical evaluation?
What is included in a clinical evaluation?
What is clinical evaluation? Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.
How do you perform a clinical evaluation?
There are four discrete stages to perform a clinical evaluation of a medical device.
- Stage 0: Scope and plan.
- Stage 1: Identification of pertinent data.
- Stage 2: Appraisal of pertinent data.
- Stage 3: Analysis of the clinical data.
- Stage 4: Finalize the report.
What is clinical evaluation report?
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.
Which Meddev guideline is used for clinical evaluation?
MEDDEV 2.7/1 REV 4 IS A DOCUMENT WHICH PROVIDES GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS AND NOTIFIED BODIES WHO MUST PERFORM CLINICAL EVALUATIONS FOR MEDICAL DEVICES THAT FALL UNDER 93/42/EEC AND 90/385/EEC.
Who should perform the clinical evaluation?
6.4. Who should perform the clinical evaluation? The clinical evaluation should be conducted by a suitably qualified individual or a team.
What is the purpose of clinical evaluation?
The overall aim of a clinical evaluation is to assess and analyze clinical data regarding the medical device to provide evidence for the product’s clinical safety and performance.
When should clinical evaluation be conducted?
6.2. When is clinical evaluation undertaken and why is it important? Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. Usually, it is first performed during the development of a medical device in order to identify data that need to be generated for market access.
Who is responsible for clinical evaluation?
What is the difference between clinical evaluation and clinical investigation?
Clinical investigation refers to a systematic clinical trial of a medical device that uses human participants to assess the safety and/or efficacy of the device. One way to differentiate between clinical evaluation and clinical investigation is to remember that a clinical evaluation is always necessary.
What is a clinical evaluator?
A Clinical Evaluator is a person or a team who is actively involved in the various stages of the clinical evaluation like collection, appraisal, and analysis of clinical data of the medical device to demonstrate its conformity to general safety and performance requirements.
Does FDA require clinical evaluation report?
The FDA does not require a clinical evaluation report (CER), and up until 2010, only some CE Marked products were required to provide a clinical evaluation report (CER).
What does clinical evaluation is advised mean?
Clinical Evaluation is a process to collect and assess all clinical data relating to a device and to evaluate whether there is sufficient clinical evidence to demonstrate conformity to the relevant regulatory requirements. This process and its results are documented in a Clinical Evaluation Report.