MedTrace Pharma takes step towards CE marking
A notified body has signed a contract to review MedTrace Pharma’s aQuant software and patient kit products with an eye to CE marking.
The notified body, BSI, is based in the Netherlands.
“We’re encouraged that BSI has agreed to audit our products,” says Rune Wiik Kristensen of MedTrace Pharma. “Because there are currently a very limited number of Notified Bodies available in the medtech industry, there can be a long wait to start a process with a notified body. Having BSI accept MedTrace Pharma as a client gives us a feeling of confidence.”
The entire audit process is expected to end with a CE mark, which certifies that a product fulfills all the requirements of European Medical Device Regulation and performance and safety standards.
CE marking is required for a product to be sold commercially within the European Union. MedTrace Pharma’s aQuant software and patient kits must live up to the Medical Device Regulation (MDR) as they are classified as medical devices in the European jurisdiction.
A notified body is an organization that can assess the conformity of products before they are placed on the market. Notified bodies carry out inspections and audits related to conformity assessment procedures and perform assessments of the product technical documentation, where a third party is required.