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 certif...»
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 survei...»
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 authori...»
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 increas...»
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 relati...»
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...»
The dispute is based on the claim that appearance features of Brompton Bicycles, which have been produced and sold in the same form since 1987 by the Designer SI and Brompton Bicycle Limited Company and can be adjusted to three different positions (folded, unfolded and stand-by) are copied in the production of ‘Chedech Bicycles’ by Get2Get, thus infringing the copyright in the Brompton Bicycle.
The dispute commenced at the local level before the Belgian Court (Refe...»
“The Guideline on Commercial Advertisement and Unfair Commercial Practices Conducted by Social Media Influencers” (“Guideline”), which was adopted by Advertisement Board (“Board”) as per its decision numbered 2021/2 and dated 4 May 2021, is preliminary and substantial legislation regarding social media influencer’s advertising activities. Nevertheless, the Board imposed several sanctions on the social media influencers prior to the Guideline on the grounds of the dispositions...»
Sending a warning letter is not a pre-condition to enforce patent rights as per Turkish Law. However, considering it is a cost-effective and fast way to solve disputes, patent owners may choose to send warning letters to perceived infringers.
In 2014, a global pharmaceutical company filed a patent infringement action against a Gx company asking the IP Court to request and examine the related evidence; namely, the marketing authorisation dossier of the Gx drug filed before the...»
The first six months of 2021 have witnessed significant amendments to the legislation on the prevention of money laundering and financing of terrorism. In fact, this trend started by the end of 2020. The Law on the Prevention of the Financing of the Proliferation of Weapons of Mass Destruction No. 7262 was published in the Official Gazette on December 31, 2020, and introduced substantial changes to numerous legislation such as the Turkish Commercial Code, the Law on Cheques, ...»
The data of the Central Bank of the Republic of Turkey indicate that the private sector’s loan debt from abroad and short-term loan debt in general, excluding commercial loans, have reached a level that will cause economic uneasiness.
Due to economic fluctuations and the following pandemic, the financing needs of companies are increasing day by day. Companies may need to increase their capital in order to meet these financing needs, to evaluate their idle resources and to man...»
The Regulation on the Promotional Activities of Medicinal Products for Human Use (“Regulation”) defines the scientific and product promotion meetings and regulates how the marketing authorization holders can support or organize these activities. However, the Guidelines on the Application of Electronic Scientific Meetings and Product Promotion Meetings (“Guidelines”) which has been prepared taken into consideration the electronic scientific meetings and electronic product prom...»