The Medical Device Regulation (“MDR”) no 2017/745 prepared by the EU Commission has been published and is planned to enter into force on May 26, 2020. However, the MDR's implementation date has been delayed by one year to enable healthcare institutions and economic operators to prioritize the fight against the coronavirus (Covid-19) pandemic. In Turkey, with new rules to harmonize the legislation of the mdr continue the process.
On February 1, 2020, the Presidential Circular No. 2020/1 on the transition period for the UK's withdrawal from the European Union was published in the Official Gazette No. 31026. In the Circular in question, it is stated that the United Kingdom will continue to be subject to EU law until 31 December 2020.
Following the publication of this Circular, TITCK has EC certificates issued to medical device companies by notified bodies called British Standard Institute (BSI) Assurance UK Ltd, Lloyd 'Register Quality Assurance Ltd and SGS United Kingdom Limited, which are based in the United Kingdom. has released an Notice on its effects on medical devices.
According to the announcement; The expiry date of EC certificates whose validity period will expire after December 31, 2020 will be automatically drawn to December 31, 2020. In the Announcement, there is also detailed information regarding the EC certificates whose validity periods were extended or shortened before the said Announcement.
In particular, harmonization of the Regulation with MDR is a long-awaited development in the sector, and many changes are expected in the medical device sector in 2021.