Recent Development
On January 15, 2021, the Turkish Medicine and Medical Devices Authority (”TİTCK”) announced the practices for the registration and evaluation processes of medical devices post-Brexit. The TİTCK’s announcement is available online here (in Turkish).
What’s New?
The TİTCK’s announcement establishes practices for the evaluation of EC certificates issued to medical device companies by the approved organizations that are affected by Brexit and the records linked to these documents. These organizations are the British Standard Institute (BSI) Assurance UK Ltd, Lloyd’s Register Quality Assurance Ltd No. 0088, SGS United Kingdom Limited No. 0120, and UL International (UK) Ltd No. 0843.
The announcement elaborates the following:
- The Product Tracking System (tr.ÜTS) registrations of the relevant approved organizations were deactivated as of January 15, 2021. Medical device companies have been given 60 days to update their EC certificates issued by the relevant approved institutions. If the documents and related medical device records on the ÜTS are not updated with a valid EC certificate issued by another approved organization, the records will be rejected.
- If the approved organization numbers and EU authorized representative information on the technical documents differ from the EC certificate of the medical device, these incompatibilities will be taken into consideration in the medical device applications made through the ÜTS. If there is an incompatibility, the medical device application will be rejected or will require revision, depending on the status of the current ÜTS record.
Conclusion
The TİTCK continues to provide guidance for medical device companies. Companies should follow the TİTCK’s announcements and update their ÜTS registrations in accordance with the TİTCK’s announcement.
