Renewal of EC Certificates After Brexit

On 15 January 2021, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) on the deactivation of Product Tracking System registrations of notified bodies located in the UK following the end of the UK-EU transition period. The registrations were deactivated on the date of the publication of the announcement, although affected medical device companies will have a 60-day period to update the system with valid EC certificates (issued by the EU notified bodies). After 60 days, medical devices that do not have a valid EC certificate will be rejected by the system.

During the updating procedure, if it is determined that the EU notified body numbers differ between documents that are submitted for a single device, the record application of the device will be rejected.

First published by Practical Law, in 02.02.2021

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