Pre-market notification procedure for Class I Devices
- Our relations need to be established – 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.
- A fee will be required (against an invoice which will be issued) for your 1st Notification file which will hold ALL of your current Class I medical devices allowing Obelis to prepare and submit this file to the European Authorities.
- We 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 registration file to be submitted to the European Authorities.
- Obelis will then submit the registration file in your behalf acting as your appointed European Authorized Representative as required by the European Directive for Medical Devices.
- 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. From this point you may affix the CE marking on your product and commence sales. Obelis will guide you through the correct manner of affixing the CE marking on your device (with the accompanying documentation which needs to be available) and the correct manner in which a product needs to be in order to enter the European community.
- Within a period of time (dependent on the Authorities’ work load) we shall receive the registration codes on your registration file from the Authorities (there will be a Tax for the release of these codes- 124.00 Euros)- these codes (which will actually replace the Certification of CE Registration as a valid proof that you as a manufacturer and your devices are complying with the European Regulation applicable to your type of device) will need to be kept in your files but do not require to be mentioned on your devices or on your CE certificate (your EC Declaration of Conformity will act as your CE certificate as explained).