The New Medical Device Regulations – A Safer Sector Subject to Closer Scrutiny

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.

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