Harmonization with the EU Medical Devices Regulation


Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published and will enter in force on 26 May 2020. As a non-EU country, TITCK published an announcement on 30 December 2019 that harmonization of the new rules established by the MDR with the Turkish regulations continues.

On 1 February 2020, Presidential Circular numbered 2020/1 was published in Official Gazette numbered 31026 on the transition period for the UK’s exit from European Union membership. This Circular states that the UK will continue to be subject to EU law until 31 December 2020.

Upon publication of this Circular, TITCK published an Announcement concerning the effects of this transition period on medical devices whose EC certificates were issued by the notified bodies named as the British Standard Institute (BSI) Assurance UK Ltd, Lloyd’ Register Quality Assurance Ltd and SGS United Kingdom Limited, located in the UK.

According to the Announcement, the expiry dates of EC certificates whose validity period will expire after 31 December 2020, will automatically expire on 31 December 2020. The Announcement also gave detailed information for EC certificates whose expiry dates had been extended or shortened prior to this Announcement.

The harmonization of the Regulation has been long awaited by the industry, and it is expected that the year 2020 introduces many changes in the medical device sector. 

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