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Indegene

Indegene assists in CE Marking Registration Support in EU as per the IVD Directive with 100% accuracy

The Customer

A leading Indian healthcare company seeking support for obtaining CE Marking Registration, which is a regulatory requirement for marketing medical devices in the European Union

The Need

  • Support for EU CE Marking/ registration (per IVDD) of multiple COVID -19 Test Kits​

    Support in gap assessment and remediation of the product technical documents​

    Support in appointment of authorized representative in EU and registration of the products in EU​

The Solution

End-to-end consulting and solutions for successful CE marking through a fast-track approval process

Guidance on conformity assessment route

Appointment of a reputed Authorized Rep​

Comprehensive compilation of technical dossier and on-time submission to the Competent Authority (Dutch Authority)​

Liasoning with the competent authority for the release of the CE Certificate

Outcomes

100%

Accuracy in Technical Dossier

0

Review Comments from notified body

1 Week

Time taken to obtain CE certification