What is the value of CE-mark and other regulatory approvals when assessing diagnostic tests?

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In the search for available diagnostic tests it is important to have an understanding what the value if of the CE-mark and other regulatory approvals. There has already been recalls initiated for self-tests which are not fulfilling the requirements. There are classes of diagnostic test that where the company is allowed to make a self-declaration that they have fulfilled the requirements without the involvement of an external auditor. This unfortunately creates the risk that we get products with poor quality to the market. There are ways through the certification of the company that can help give security, however there are also some non-accredited certifications that does not have any certain value.

In the absence of clarity regarding the CE-mark, we also want to evaluate the regulatory frameworks in China and the US to see if they can provide additional guidance if the product has been approved there.

The aim with this session is to create an understanding of:

• What does the CE-mark mean in terms of assurance of the quality of the product?
• What are the additional measures that can be taken to evaluate the quality of the company producing the test?
• How can other regulatory approvals help?

• Confirmed:
  • The notified body TÜV SÜD Product Service 
    • Marta Carnielli, IVD technical officer, Germany
    • Andreas Stange, VP, Germany
  • Regulatory consultant:
    • Sue Spencer, Head of In Vitro Diagnostics & Principal Consultant, Qserve Group UK, Ltd.

To access recording : https://attendee.gotowebinar.com/recording/5847070202834687234