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

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