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Implement and oversee your trial with ease
Our team is led by former notified body and competent authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.
At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device. The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses.
ECLEVAR can help in collecting the clinical data required and provide long-term clinical strategy that support your business in EU, UK and Australia.
Collect scientifically valid and MDR compliant PMCF data using our platform:
Easy GDPR compliance.
Easily comply with GDPR requirements for informed consent and data protection. Our in house data protection officer monitor the compliance for all the studies
Pre-validated and compliant data platform: Our platform is compliant with ISO14155:2020 requirements and GDPR.
Fully documented data traceability. All data inputs automatically include automatic user identification to ensure fully documented traceability from source to sponsor via using State of The Art technology Blockchain
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As shown in the clinical evaluation report, the clinical safety and performance claims are not sufficiently supported by existing clinical evidence. In order to maintain the “Vascular Device” on the European market, the customer must conduct a PMCF study to generate sufficient clinical data in accordance with “Chapter VI – Clinical Evaluation and Clinical Investigations, in particular sections 62 to 82”. And ISO 14155:2020
Goals
Confirm the safety and performance of the vascular device throughout its intended lifetime and at both anatomical sites: carotid and femoral.
Recognize and analyze emerging risks based on evidence,
Ensure continued acceptance of the benefit/risk ratio according to the EU-MDR
Identify possible systematic misuse or off-label use of product X to verify that the intended use is correct.
Methodology
A sponsor conducted a multicenter RWE study to collect clinical data on the vascular device. The objective was to examine the short- and long-term outcomes of device use when exposed to a larger, more diverse population.
All data were extracted from each patient’s medical records from the time of surgery (considered the baseline of the study) to a maximum of 3 years after surgery.
300 subjects were evaluated from 3 different sites. 150 subjects were evaluated in the carotid position and at least 150 in the femoral position.
Benefits
Contribute to a larger body of evidence under development:
representative population
Accepted by the notified body for MDR certification.
Limitation: Incomplete long-term evidence.
Solution: Establishment of a European Vascular Registry
The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.
In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.
Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.
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