Our latest article “The New Medical Device Regulations – A Safer Sector Subject to Closer Scrutiny” by Nihan Bacanak, Can Aksoy, Bengüsu Güvendi and Selen Toma is published on Lexology.
The Medical Devices Regulation numbered 2017/745 (the “MDR”) of the European Union (the “EU”) became fully effective as of 26 May 2021. Given the substantial changes that the MDR brings, it is for sure that the medical devices sector will never be the same. In parallel with the changes brought by the MDR, Turkey’s corresponding legislation has been amended with a view to harmonising the legislative framework of the country with that of the EU. The new Medical Device Regulation (the “Regulation”) has been prepared in full compliance and mostly includes very similar provisions -if not identical- with the MDR. The Regulation was published in Turkish Official Gazette on 2 June 2021 with several dates of coming into force depending on the relevant provision.
The MDR and the Regulation (together, the “New MDRs”) include more detailed and stricter requirements and responsibilities for those subject to the legislation than the current legislation, and expand the scope and classification of the in-scope products. This comes as no surprise given that as a result of the recent technological developments, the previous legislation had become obsolete in terms of meeting the need to ensure safety and effectiveness of the market, particularly in protecting the medical device users, and it had thus become necessary to amend the legislative framework to keep up with the necessities of the time.
You may reach the entire article here.
Share
Related persons
You can contact us for detailed information.


Legal Information
This briefing is for information purposes; it is not legal advice. If you have questions, please call us. All rights reserved.
You May Be Interested In
14 February 2025
Important changes in Regulation on Insurance Agencies
On 22 January 2025, Turkey’s Insurance and Private Pension Regulation and Supervision Agency (IPRSA) published the Regulation Amending the…
10 February 2025
Minimum equity amounts for payment services and electronic money institutions have been reassessed
On 30 January 2025, Central Bank of the Republic of Türkiye (CBRT) published the Communiqué on the Reassessment of Minimum Equity Amounts…
6 February 2025
Developments in Private Hospitals Legislation
Following the entry into force of the Regulation on Private Hospitals (“Regulation“) published in the Official Gazette on 30 January 2025,…
4 February 2025
Technology M&A 2025 in Turkey
Overall M&A activity in Turkey slowed down throughout 2022 and into early 2023 due to economic instability, inflation, and geopolitical…
28 January 2025
Recent developments in Turkish data protection law
The end of 2024 and the beginning of 2025 were highly active in terms of developments in data protection legislation in Türkiye. Many…
13 January 2025
New Administrative Fines Regulation For Competition Violations Enters Into Force
The Regulation on Administrative Fines for Restrictive Agreements, Concerted Practices, Decisions, and Abuse of Dominance, which governs…