What is the difference of the Clinical evaluation and clinical investigation?

Q1. What is the difference of the Clinical evaluation and clinical investigation?

Clinical Investigation is a systematic study performed in humans to access the safety and performance of a medical device based on the comprehensive analysis of available preclinical, Clinical (Safety) and post-market data relevant to the intended purpose of the device.

Clinical evaluation is a process to continuously generate, collect, analyse and assess the clinical data pertaining to a medical device under evaluation to prove the conformity with general safety and performance requirements as per its intended use by manufacturer.

Q2. When and who is responsible to conduct the clinical evaluation?

When- Clinical evaluation is an ongoing process and first conducted during the development stage of medical device throughout its life cycle.

Who- Manufacturer is responsible to conduct Clinical evaluation for initial CE-marking.

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Q3. How is the clinical evaluation related to the risk management system?
Risk management is a process of identification of risks associated with the medical device, which are further addressed in Clinical Evaluation.

Both are updated at regular intervals of time to prove the safety and performance as per the modifications in device and regulatory standards

Q4. What are the equivalent devices? How to prove the equivalency?

Equivalent device is a device from another manufacturer, which is already CE marked, clinical data of which can be used as justification for NOT conducting Clinical Evaluation for subject device. To prove equivalency, it should be technically, biologically and clinically comparable to the subject device

Q5. What are the method to be followed for the appraisal of the clinical data? Which all data has to be appraised?

Methodological quality, the scientific validity of relevant pilot data, relevance to device, relevance to intended use aspects are Quantitative and Qualitative methods based on OCEBM (Explanation of the 2011 Oxford Centre for Evidence-Based Medicine) Level of Evidence to be followed for the appraisal of the clinical data. All the pertinent data identified in Stage 1 means data from Literature search has to be appraised

Q6. Through the analysis of clinical data explain how is the conformity assessment done?

During analysis stage, any unresolved residual risks and unanswered questions should be identified and evaluated during PMCF. PMCF results plays a vital role in addressing any gaps in the clinical data. The conclusion of the analysis indicates if the safety, performance and benefits of the medical device to patients outweigh any risks, adverse events and side-effects that may be caused by it.

Q7. What are the method to be followed for the appraisal of the clinical data?

Methodological quality, the scientific validity of relevant pilot data, relevance to device, relevance to intended use aspects are Quantitative and Qualitative methods based on OCEBM (Explanation of the 2011 Oxford Centre for Evidence-Based Medicine) Level of Evidence to be followed for the appraisal of the clinical data.

Q8. What are the typical contents of a CER?

Here below is list of CER content
  • Summary
  • Scope of the Clinical Evaluation
  • General Details (Manufacturer Name & Address, Responsible Person)
  • Device Details (Description, Name, Models, Variants, Intended Purpose
Risk Class, CE marking status, Contraindications, Warnings, Precautions, Identification of Changes from previous version –if already in market)
  • Clinical Background, Current Knowledge, State Of Art
  • Device under Evaluation (Type of Evaluation -Based on available scientific literatures, Clinical investigations etc)
  • Demonstration of Equivalence (If equivalency is claimed)
  • Identification of Pertinent Data (literatures, Clinical investigations, PMS, PMCF data)
  • Data Generated and Held by the Manufacturer (PMS and its Outcome, PMCF and its Outcome, Pre-Clinical Studies, Biocompatibility Testing, Bench Testing, Electrical Safety, Software Verification & Validation, Scientific Literatures data
  • Summary and Appraisal of Clinical Data
  • Analysis of Clinical Data (Based on Safety, Acceptable Benefit/Risk Profile, Performance, Acceptability of Side-Effects)
  • CER Conclusion
  • Qualification of the Responsible Evaluators
  • Date of Next Clinical Evaluation
  • CER Approvals
Q9. What is the clinical development plan?

It is one of the requirement of MDR to have a “CLINICAL DEVELOPMENT PLAN” as part of “Clinical Evaluation”.

A clinical development plan is a blueprint of entire process of medical device lifecycle from planning to post launch stage including Designing Stage, Prototype Development, Testing Stage, Preclinical Investigations, First in Human Studies, Feasibility Pilot Studies, Pivotal Studies and a PMCF with an indication of milestones and a description of endpoints included

Q10. In what cases the clinical data not deemed to be appropriate?

Where demonstration of conformity with Essential Requirements as per clinical data is not deemed appropriate, it should be justified with pre-clinical evaluation or clinical risks

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