On 30 May 2022, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) on its official website, stating that a draft Communiqué on the Instructions for Use in Electronic Form for Medical Devices (Draft) has been prepared and asked stakeholders to provide feedback on the Draft.
As part of Turkey's alignment process with EU law, the Draft has been prepared in accordance with Commission Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745.
The Draft sets out the main framework on provision of instructions for use documents in an electronic environment, the principles of informing the end user in electronic form of the instructions for use and the liabilities of notified bodies. In its announcement, the Agency stated that stakeholders may submit their feedback on the Draft until 20 June 2022.
First published by Practical Law Life Sciences Monthly Newsletter in Jul 18, 2022.