Transition Process for Product Tracking System
The announcement clarifies the status of certified documents, product registration and movement requirements relating to medical devices in the context of the transition to the Regulation. The announcement states due dates for the certified documents and new product registrations that take into consideration the Product Tracking System registrations. The announcement also sets out rules for the status of: · Products certified by British notified bodies. · Products with… »
In Vitro Medical Device Regulation Published
The Regulation aims to protect the health and safety of patients and users of medical devices, supply high quality medical devices, support innovation, and create a transparent, robust and sustainable medical device market. The Regulation includes new rules regarding: · Device classification. · Stricter oversight of manufacturers by notified bodies. · The responsible person. · Unique Device Identifier marking for devices. · EUDAMED registration. · Increased post-market… »
New Medical Device Regulation Published
Under the Regulation, the processes for placing a medical device on the market, putting it into service and distance selling are now explicitly regulated. Devices that are in conformity with the relevant harmonised standards shall be presumed to be in conformity with the requirements of the Regulation. Where the manufacturer of a device is not established in an EU member state or Turkey, the device may only be placed on the market if the manufacturer designates a sole… »
Commitments on The Transfer of Data Abroad
In lieu of a comprehensive list of countries that personal data can be transferred to freely, the procedure for data transfers outside of Turkey is more complicated than most. Begüm Okumuş and Selin Başaran Savuran, Managing Associate and Senior Associate respectively at Gün + Partners, explore this process and how it is likely to evolve in the future. In an increasingly digitalised and globalised world, the need for transferring personal data abroad is inevitable and… »
Remote Working in the New Normal After COVID-19
Global COVID-19 pandemic, which has been going on for over a year now, had inevitable impacts on the business life. During the pandemic, various measures have been taken into place at workplaces to fight this outbreak. Remote working was one of the most prominent measures of all. It is beyond question that remote working model will maintain its significance at workplaces even after the pandemic. As per the Turkish Labour Act (the “TLA”), remote working is an employment… »
Data Protection Officer Within the Scope of the Personal Data Protection Law and the GDPR
Data protection officer (“DPO”) is a concept regulated under the General Data Protection Regulation (“GDPR”), which came into force in May 2018 in the European Union. The purpose of regulation of the DPO is to appoint a person who will be responsible for monitoring compliance of data controllers with data protection legislation. The GDPR imposes an obligation to appoint a data protection officer on data controllers who meet a number of criteria as well as regulates the duties… »