Process for compliance with Obelis

The notification of “IVD” product families as per IVDD 98/79/EC (Article 10) can only be completed through the appointed “European Authorized Representative”
Establishment of relations with Obelis – meaning you as a Non-EU manufacturer appointing Obelis as your European Authorized Representative as required by the directive- doing so by mutually signing an E.A.R agreement which will be presented to you upon your request
Obelis will need to receive from you all the required documentations in their Original format, something which will be explained to you by our notification department once you will become a client (the documentation which is required is mainly filled out templates which we will present you with) allowing us to compile the Notification file to be submitted first to the European IVD Authorities where the European Authorized Representative is established (in this instance Belgium)
Obelis will submit the Notification file in your behalf acting as your appointed European Authorized Representative as required by the European Directive
Within two weeks time Obelis will be able to equip you with the “Certification of CE Registration” which will be your proof that your file has been duly submitted to the European Authorities.
Upon submission of the Notification File- the Authorities will require the remittance of a Notification Tax
Obelis will then submit your file to the required EU Member State competent authorities (dependant on your instructions prior to market entry) and equip you with a “Certification of CE Registration” for each of the requested countries (within two weeks time of submission) - when this document is received by you- you may commence Sales!

Process for compliance with Obelis

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