Medical Device News November 2024 Regulatory Update

[@munasofi5037]

Hi Munir, thank you for keeping us updated on medical device topics, and for the informative blog posts that provide further clarification on these subjects.

[@gulnihalsevim3908]

In order to eliminate the possible problems that may arise in terms of data security and responsibility arising from the situations where the peoplewho perform medical device document and product registration transactions on behalf of the companies in the Product Tracking System (ÜTS) in the “Manufacturer/Importer/Dealer/Exporter” and “Custom-made orthotic prosthesis center” company types are not the direct employees of the companies, software development has been completed in the ÜTS system so that a person can be defined as a company user in a maximum of 10 companies for the specified company types and will be implemented with the first version update.

[@simhasibony5376]

I encounter problems to find a notified body for a start up.

[@EasyMedicalDevice]

If you need help let us know. The only moment we had a problem to find one was only because the notified body didn‘t consider the product as a medical device or not on scope of their certification. So if you need help, hire us to find one and work with them.