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Medical Device Regulations & Brexit


Sunday, February 28, 2021
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.
The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the COVID-19 pandemic is still a major issue, the expiry of the one-year deferral is fast approaching.
The Regulation recognised that the COVID-19 outbreak and the associated public health crisis presented an unprecedented challenge to EU member states and constituted an immense burden for national authorities, health institutions, Union citizens and economic operators. Further, it recognised that the public health crisis created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been ....

United Kingdom , Northern Ireland , Great Britain , Regulatory Agency , Medical Device Directives , Notified Bodies , United Kingdom Medicines , Agreement Act , Medical Device Regulations , Regulation 2020 561 , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , நன்று பிரிட்டன் , மருத்துவ சாதனம் வழிமுறைகள் , அறிவிக்கப்பட்டது உடல்கள் , ஒன்றுபட்டது கிஂக்டம் மருந்துகள் , மருத்துவ சாதனம் ஒழுங்குமுறைகள் ,