Clinical Evaluator for Medical Device

A Clinical Evaluator, whether an individual or a team, plays a pivotal role in the comprehensive process of clinical evaluation for medical devices. Their responsibilities encompass the collection, appraisal, and analysis of clinical data to demonstrate the device’s conformity to General Safety and Performance Requirements (GSPR).

Given the critical nature of their role, Clinical Evaluators are subject to thorough scrutiny, particularly during technical file review conducted by Notified Bodies. During technical documentation file review especially clinical evaluation reports review, the appointed Notified Body reviewer meticulously examines the Declaration of Interest (DOI) and the Curriculum Vitae (CV) of the Evaluator(s) designated by the manufacturer. These documents must not only be current but also signed and dated, underlining the significance of the Clinical Evaluator’s role in the evaluation process

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 have 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 travelling 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 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

If the risks are acceptable when compared with the benefits

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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 know about the device technology and application; and also, the diagnosis and management of conditions intended to be managed 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.

Job Responsibilities and Duties

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 weigh 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 evaluator are also considered.

Looking for Clinical Evaluation?

Accelerate the preparation of your medical device Clinical Evaluation Report (CER) with the expertise of a clinical evaluator, writer, and consultant. Our team has extensive experience in MDR technical documentation and responding to Notified Bodies, ensuring early approvals of CER.

CLINICAL EVALUATION FEE

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Frequently Asked Questions

Is the Clinical Evaluation for Legacy Device being different from others?

No exemption is allowed for legacy devices. All device categories must follow the same.

MDCG 2020-6 Appendix II provides the minimum information expected for legacy device CEP