Notification files for Class I Medical Devices, kits and procedure packs can currently be submitted in an electronic format to the Belgian Federal Agency for Medicines and Health Products (FAMHP).
The completion of the Notification procedure constitutes a prior condition to ensure the compliancy of Medical devices with the essential requirements of the MDD Directive; and therefore is a necessary step in order to affix the CE marking and sell the devices freely within the EU Market.
Background and context
The introduction of an E-submission procedure comes in the context of the Competent Authorities’ actions aimed at improving automated administrative processes and operational efficiency so that paper handling is reduced.
Following this innovation, the submission of hardcopies is not requested anymore which entails a relevant reduction of the total time-frame required by the Competent Authorities to revise the files.
Obelis, as a professional EC Rep, shall perform the Notification on behalf of Non EU manufacturers.
Obelis, as a professional consultancy company providing EC Rep Services, is constantly committed to supporting manufacturers towards their compliancy procedures and to assure their smooth and successful access to the EU Market.
If you require further information on the notification of Class I Medical Devices, kits and procedure packs, please contact us!