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. They play a major role in Clinical Evaluation.
The importance of a Clinical Evaluator is so much that during an audit, the Notified Body reviewer will review the Declaration of Interest(DOI) and the Curriculum Vitae (CV) of the Evaluator(s) appointed by the manufacturer. Both documents must be up-to-date, signed, and dated.
The DOI and CV of the evaluator(s) must be held by the manufacturer and should cover the relevant financial interests outside the current work as an evaluator(s). Some of the typical contents of a Declaration of Interest has the information on (Meddev 2.7/1 Rev.4):
- employment by the manufacturer;
- interests in connection with the manufacturing of the device or its constituents;
- ownership/ shareholding possibly affected by the outcome of the evaluation;
- benefits such as traveling or hospitality (if beyond what is reasonably necessary for the work as an employee or external evaluator);
- grants sponsored by the manufacturer;
- interests in connection with intellectual property, such as patents, copyrights, and royalties (whether pending, issued, or licensed) possibly affected by the outcome of the evaluation, and so on.
The Clinical Evaluator identifies specific aspects of the clinical data evaluation for their specific review. During clinical evaluation, they should verify:
- If the benefit/risk profile, undesirable side-effects (whether previously known or newly emerged) and risk mitigation measures are
- Able to prove the safety and performance of the device
- Correctly addressed in information materials
- Addressed in the current PMS plan
2. If the risks are acceptable when compared with the benefits
Requirements to act as Clinical Evaluator
- The clinical evaluator must have training and experience in relevant fields corresponding to the device under evaluation.
- The clinical evaluator must have knowledge of the device technology and application; and also the diagnosis and management of conditions intended to manage or treated by the device, medical alternatives, and treatment standards.
- They should be able to assess the degree of relevance of papers selected through a literature search.
- They should also be able to differentiate if the relevant data is useful for the application or use of the device.
Clinical Evaluator also should:
- Identify information contained in each document,
- Evaluate the methodological quality of work done by the authors and from that, the scientific validity of the information,
- Determine the relevance of the information to the clinical evaluation, and
- Systematically weight the contribution of each data set to the clinical evaluation.
- Set the plan for appraisal of the clinical data to conduct a thorough and objective appraisal of clinical data.
- Responsible for conducting the appraisal by evaluating the methodological quality and scientific validity.
- Examine the methods used to generate/collect the data and evaluate the extent to which the observed performance or safety outcomes can be attributed to the intervention with the device.
- Verify whether clinical investigations have been defined to confirm or refute the manufacturer’s claims for the device; and whether these investigations guarantee the scientific validity of the conclusions by including an adequate number of observations.
- Involve with the analysis of the clinical data by identifying appropriate criteria to be applied for a specific evaluation to demonstrate the compliance of the device to GSPR.
- Identify additional clinical investigations or other measures that are required to generate any missing data and eliminate compliance issues.
- Perform post-market activities like PMS, PSUR, and PMCF in association with other team members.
- Conduct PMCF – the clinical evaluators should identify residual risks, any uncertainties, or unanswered questions.
During the preparation of the CER, the opinions of the clinical evaluators are also considered.