Medical Device Clinical Evaluation

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Medical Device Clinical Evaluation

Purpose of Clinical Evaluation

EU 2017/745 Medical Device Clinical Evaluation

Medical Device Clinical Evaluation Identify, collect, appraise, and analyze clinical data from clinical investigations, literature, and post-market surveillance to demonstrate the medical device’s safety and performance.

Medical devices must be evaluated using clinical data throughout their lifetime in order to justify their safety and performance.

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The Medical Device Clinical Evaluation Services we provide includes:

Clinical Evaluation Plan (CEP)

method for identification, collection, and analysis of the clinical data with the proper schedule…read more

Analysis of Clinical Data

pre-clinical and clinical data to ensure requirement to safety, performance, risk-benefit profile, and undesirable side effects…read more

Appraisal of Clinical Data

appraisal of favorable and unfavorable clinical data in terms of its suitability, scientific validity, and data contribution…read more

Demonstration of Equivalence

demonstration of its technical, biological, and clinical equivalence with the medical device under clinical evaluation…read more

Literature Search and Review

literature search based on the review questions on safety, performance, undesirable side effects, and risk-benefit analysis…read more

Clinical Evaluation Report

demonstration of safety and performance of the medical device…read more

Know 2017/745 on Clinical Evaluation

The medical device clinical evaluation process should be planned, conducted, and documented in detail throughout the lifecycle of medical devices and shall be updated if required based on the clinical data obtained from the PMCF plan.
Before the medical device is placed on the market and put into service, it should demonstrate conformity with the medical device’s general safety and performance requirements.
The clinical risks shall be addressed as part of clinical investigations, clinical evaluation, and post-market clinical follow-up. The risk management system should be carefully aligned and updated if required.
For class III devices and certain class IIb devices, if required, consult an expert panel before the clinical evaluation and investigation. This should be part of the clinical development plan.
If the medical device is a class III and implantable device which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation: — is based on sufficient clinical data, and — is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available for such devices clinical Investigation is not required.
As per MDR Annex I, conformity with relevant general safety and performance requirements should be set out under the normal conditions of the intended use of the device and evaluate the undesirable side effects and the acceptability of the risk-benefit ratio. This should be documented in the clinical evaluation plan.
The relevant scientific literature currently available relating to the safety, performance, design characteristics, and intended purpose of the device, where it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data related and the data adequately demonstrate compliance with the relevant general safety and performance requirements;
The manufacturer of the equivalent device should have a contract to show for full access to the technical documentation on an ongoing basis to demonstrate the equivalence.
For products without an intended medical purpose, the clinical data concerning safety should be from post-market surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
For class III devices and implantable devices, the PMCF evaluation report, and the summary of safety and clinical performance shall be updated at least annually.
The output of the medical device clinical evaluation report should be updated in Summary of Safety and Clinical Performance (SSCP) and Risk Management.

Medical Device Clinical Evaluation Report shall be updated with the clinical data obtained from the PMCF plan in accordance with Part B of Annex XIV, the post-market surveillance plan referred to in Article 84, the Periodic Safety Update Report (PSUR) according to the article.

When to demonstrate in medical device Clinical Evaluation?

The conformity assessment of safety and performance of the medical device should be demonstrated before it is released for use to the customer.

What are the stages of Medical device Clinical Evaluation

STAGE 0 [Scoping and planning]
STAGE 1 [Identification of pertinent data]
STAGE 2 [Appraisal of pertinent data]
STAGE 3 [Analysis of the clinical data]
STAGE 4 [The clinical evaluation report]

Explain Clinical Benefit

The positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.

Clinical Evaluation Report Writing as per MEDDEV 2.7.1 Rev 4 and MDR article 61

CER writing services means the art of content writing and arranging documents by a clinical evaluation report writer / expert by cross-references between the clinical evaluation report's contents and the pertinent documentation supporting them. Which claims are supported by which pieces of evidence and which express the opinions of the assessors should be very clear. With cross-references to the location in the technical documentation from the manufacturer, the report should include references to literature-based data as well as the titles and investigational codes of any clinical trial reports (if applicable and accessible).

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