BREXIT: Turkey Amended its Approach on Medical Device Registrations
On April 12, 2021, Turkish Medicines and Medical Devices Agency (“TITCK”) published the Amending Announcement regarding the Practices to be Carried Out After the Transition Period Regarding BREXIT (“Announcement”), abolishing the current practices and bringing out new approach on medical device registrations with purpose to ensure uniform practices with the EU.
The Announcement explains that pursuant to the announcement of TITCK dated January 15, 2021, ÜTS registrations of the notified bodies resident in UK affected by the BREXIT, namely British Standard Institute (BSI) Assurance UK Ltd, Lloyd ‘Register Quality Assurance Ltd, SGS United Kingdom Limited and UL International (UK) Ltd, has been inactivated as of the date of February 7, 2021 and a period of 60 days has been granted to medical device companies concerning EC certificates issued by the relevant notified bodies. The 60-days period granted to medical device companies concerning EC certificates issued by the relevant notified bodies, has expired on April 8, 2021. Thus, the registration documentation and relevant medical device records which have not been updated with a valid EC certificate issued by another notified body were deemed as rejected.
As per the Announcement, it is explained that some of the practices previously announced by TITCK are amended for harmonized practices with EU. Accordingly, there will be no restrictions applied on the movements of medical devices that have been singularized by making a production or import notification on the Product Tracking System (“ÜTS”) before April 8, 2021. However, ÜTS registration should be updated before singular product notifications to be made after April 8, 2021, for the medical devices whose ÜTS registration were deemed as rejected since the EC certificate was not updated.
The Announcement emphasizes that concerning medical devices whose ÜTS registration was deemed as rejected since the EC certificate was not updated with an EC certificate issued by a notified body other than the ones resident in UK, if such medical devices are granted with a valid EC certificate issued by a new notified body within the scope of Regulations on Medical Devices in effect (Council Directive 93/42/EEC on Medical Devices, Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices, or Council Directive 90/385/EEC on Active Implantable Medical Devices) and are registered in the system, differences in information regarding the notified body between the renewed EC certificate and the declaration of conformity, label, user manual and other similar technical documents shall not be evaluated negatively for the registration. This rule will also be applicable for medical devices whose ÜTS registration was not deemed as rejected since the EC certificates issued by notified bodies resident in UK were updated by another notified body before April 8, 2021, in case the ÜTS registration needs to be updated for any reason within the scope of Regulations on Medical Devices in effect.
Lastly, the Announcement evaluates Turkey’s adoption of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“MDR”). Accordingly, concerning the medical device registration applications to ÜTS to be made within the scope of the MDR, the incompatibilities in information regarding the notified body between the EU certificate(s) associated with the medical device in question and the EU declaration of conformity, label, user manual and other similar technical documents shall be considered as a means for rejection. With this respect, depending on the status of the current ÜTS record of the medical device, the application would be returned for revision or rejected.
Background
TTICK published the Announcement regarding the Practices to Be Carried Out After the Transition Period Regarding BREXIT on January 15, 2021 since the transition period is over. As per this 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 were set forth.
Accordingly, ÜTS registrations of the above-mentioned notified bodies affected by the BREXIT were announced to be inactivated as of the date of January 15, 2021 and a period of 60 days was granted to medical device companies concerning EC certificates issued by the relevant notified bodies. It was stipulated that in case the registration documentation was not updated with a valid EC certificate issued by another notified body after the expiration of 60-days period, such medical device registrations and relevant medical device records shall be deemed as rejected. (To further read please see: https://herdem.av.tr/brexit-turkey-s-new-approach-on-medical-device-registrations )
Simge Kılıç, Ezgi Ceren Aydoğmuş