eCRF (Electronic Case Report Forms)

As the clinical evaluation report shows, claims of safety and clinical performance are not sufficiently supported by existing clinical evidence.

To keep the “Vascular Device” on the European market, the client must conduct a PMCF study to generate sufficient clinical data in accordance with “Chapter VI – Clinical Evaluation and Clinical Investigations, particularly Sections 62 to 82” and ISO 14155:2020.

Objectives

1. Confirm the safety and performance of the vascular device throughout its intended lifespan at two anatomical sites: carotid and femoral.
2. Identify and analyze emerging risks based on factual evidence.
3. Ensure continued acceptance of the benefit-risk ratio according to the EU-MDR.
4. Identify any potential 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 aim was to examine short- and long-term outcomes of device use when exposed to a broader and more diverse population.
• 300 subjects were evaluated from 3 different sites, with 150 subjects assessed in the carotid position and at least 150 in the femoral position.

Benefits

1. Contributes to a broader body of developing evidence.
2. Representative population.
3. Accepted by the notified body for the MDR certificate.
4. Limitation: Incomplete long-term evidence.

Solution: Establishment of a European Vascular Registry