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This document certifies that Dia Sure Immunodiagnostic LLP\'s IVD device complies with the Council Directive 98/79/EC, with Obelis s.a. acting as the European Authorized Representative for the notification and conformity assessment of the device.
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How to fill out certificate of ivd notification

01
Obtain the certificate of IVD notification form from the relevant regulatory authority's website or office.
02
Read the instructions carefully to understand the required information.
03
Enter the manufacturer's name and contact information in the designated fields.
04
Provide detailed information about the in-vitro diagnostic (IVD) device, including its name, type, and intended use.
05
Include relevant technical specifications and any applicable standards the device adheres to.
06
Specify the country or region where the IVD will be sold or distributed.
07
Sign and date the form to validate the application.
08
Submit the completed form along with any required supporting documents to the appropriate authority.

Who needs certificate of ivd notification?

01
Manufacturers of in-vitro diagnostic devices.
02
Authorized representatives or distributors of IVD devices.
03
Companies planning to market IVD devices in a specific country or region.
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The certificate of IVD notification is a document that serves as confirmation that an in-vitro diagnostic (IVD) medical device has been notified to the regulatory authority in a specific jurisdiction, ensuring compliance with applicable regulations.
Manufacturers, importers, and distributors of in-vitro diagnostic medical devices are required to file the certificate of IVD notification before marketing their products in the respective jurisdictions.
To fill out the certificate of IVD notification, provide detailed information about the IVD device, including its name, intended use, risk classification, manufacturer details, and any relevant documentation required by the regulatory authority.
The purpose of the certificate of IVD notification is to ensure that IVD medical devices meet safety and performance standards before they are allowed to be marketed, thereby protecting public health.
The information that must be reported on the certificate of IVD notification includes the device name, model number, manufacturer details, intended use, classification, instructions for use, and any additional safety or efficacy data required by the regulatory authority.
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IVD notification European Authorized Representative Directive 98/79/EC Obelis s.a. Dia Sure Immunodiagnostic LLP CE marking medical devices In-Vitro Diagnostic COVID-19 test compliance certification

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