In brief
The Turkish Medicine and Medical Devices Authority (TİTCK) published a critical announcement covering the topic of new practices for the registration and evaluation process of medical devices post-Brexit.
Contents
- Recent developments
- What’s new?
Recent developments
On 12 April 2021, TİTCK announced the amendment of practices for the registration and evaluation process of medical devices post-Brexit published on 15 January 2021. TİTCK’s announcement regarding the amendment is available here (in Turkish).
What’s new?
TİTCK’s announcement establishes amended practices for evaluating EC certificates issued to medical device companies by approved organizations that are affected by Brexit and the records linked to these documents.
The announcement elaborates on the following:
- There will be no restrictions upon the movement of medical devices that are singularized by production or importation declaration through the ÜTS until 8 April 2021. Nonetheless, for single product declarations made after 8 April 2021, if the relevant document is rejected because of a delay in update, the relevant medical device and its relevant documentation must be updated and registered to the system.
When medical devices that lose their registration with the ÜTS after 8 April 2021 are later registered to the system with a recent EC certificate by another approved organization in accordance with 93/42/EEC, 98/79/EC or 90/385/EEC ); if there are inconsistencies between documents linked with the relevant device, these will not be taken into consideration in the medical device applications. Therefore, the medical device application will not be rejected or will not require revision, depending on the status of the current ÜTS record.
