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Harmonization with the EU Medical Devices Regulation


Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published, and was planned to be enter in force on 26 May 2020. However, the MDR’s implementation date has been delayed for a year to enable healthcare institutions and economic operators to prioritize the fight against the Covid-19 pandemic. The legislation in Turkey continues the process of harmonization with the new rules set by the MDR.

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 the European Union membership. This Circular stated that the UK will continue to be subject to the 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 the EC certificates whose validity period expired after 31 December 2020, will, indeed, 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.

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

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