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: Comprehensive Support for EU CE Marking and Registration
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 the appointment of authorized representatives in the EU and registration of the products in the EU
The Solution: Fast-Track CE Marking and Approval
End-to-end consulting and solutions for successful CE mark registration 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
The expertise provided by Indegene in guiding through the conformity assessment route was pivotal in the fast-track approval process, leading to the rapid acquisition of CE certification within just one week. The efficiency in liaising with the competent authority and streamlining the approval process helped the customer ensure the safe and effective marketing of their products.
Ready to enhance compliance efficiency? Contact us now to explore innovative solutions tailored to your unique needs.
100%
Accuracy in Technical Dossier
0
Review Comments from notified body
1 Week
Time taken to obtain CE certification