BREXIT: Turkey’s New Approach on Medical Device Registrations
Following the conclusion of long-standing proceedings of BREXIT, Turkey regulated the transition period via the Circular issued by the Presidency of the Republic of Turkey dated February 1, 2020 which determined the expiration of the transition period as December 31, 2020. With the Circular, government institutions were instructed to consider the provisions of the Withdrawal Agreement and inform and lead the public accordingly as necessary. According to the Withdrawal Agreement, during the transition period, legal status quo was decided to be maintained in terms of any transactions arising from bilateral or multilateral agreements executed by and between Turkey and/or EU and the UK would continue to be treated as an EU member state.
Turkish Medicines and Medical Devices Agency (“TITCK”) has recently published the Announcement regarding the Practices to Be Carried Out After the Transition Period Regarding BREXIT (“Announcement”) on January 15, 2021 since the transition period, which was designated to be ended on December 31, 2020, is over. With the Announcement, the previous announcement of TITCK regarding the documents issued by notified bodies affected by the BREXIT process and the registration and evaluation processes of the medical devices within the scope of these documents in the Product Tracking System (“ÜTS”) has been abolished since it is not applicable after the completion of the transition period.
Pursuant to the Announcement, the procedure and principles to be applied regarding the EC certificates issued by notified bodies resident in UK, namely British Standard Institute (BSI) Assurance UK Ltd, Lloyd ‘Register Quality Assurance Ltd, SGS United Kingdom Limited and UL International (UK) Ltd, and the evaluation of these medical device records are set forth.
Accordingly, ÜTS registrations of the above-mentioned notified bodies affected by the BREXIT are inactivated as of the date of January 15, 2021 and a period of 60 days will be granted to medical device companies concerning EC certificates issued by the relevant notified bodies. After 60 days in case the registration documentation is not updated with a valid EC certificate issued by another notified body then such medical device registrations and relevant medical device records will be deemed rejected.
Additionally, for the abovementioned 60-days period, no restrictions will be imposed on the movements of medical devices that have been singularized by making a production or import notification on ÜTS. On the other hand, for the medical devices of which ÜTS registration was deemed to be rejected since the EC certificate was not updated, ÜTS registration should be updated before singular product notifications to be made.
It is also emphasized that for the applications to be made via ÜTS, the differences between the EC certificate associated with the medical device in question and the declaration of conformity, label, user manual and other similar technical documents regarding the notified body numbers and the EU authorized representative information shall be evaluated for the registration. In this respect, in case of difference between the relevant documents and the label, the medical device application shall be concluded negatively by rejection or revision request depending on the current ÜTS registration status of the medical device subject to the application.
Simge Kılıç, Nihan Ünal
