Medical Device Regulation (“Regulation”) has been published in the Official Gazette numbered 31499 on 2 June 2020.
With the Regulation prepared in accordance with the EU Medical Device Regulation numbered 2017/745 (“MDR”), it is aimed to provide a safer use for manufacturers and medical device users with a transparent and sustainable system.
In this context; new noteworthy provisions are the definition of a medical device, classification of products, distance sales…
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The Law Amending the Criminal Procedure Code and Certain Other Laws No. 7331 (“Law No. 7331”) -known as the 4th Judicial Reform Package - which entered into force by publication in the Official Gazette dated July 14, 2021, significantly reduced the time limits foreseen in the Administrative Jurisdiction Procedure Law No. 2577 (“Law No. 2577”) in terms of the administrative authorities in the application procedures before filing of administrative actions. Accordingly:
As per…
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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…
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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…
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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…
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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…
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