MHRA Regulatory Flexibilities during the COVID-19 Pandemic

2024-01-15T10:39:50+00:00June 4th, 2020|

MHRA Regulatory Flexibilities during the COVID-19 Pandemic In the wake of the on-going fallout from the COVID-19 pandemic, the MHRA has been active in taking steps to lessen the regulatory burden on companies working on issues central to the fight against COVID-19. Since the first publication of the guidance on [...]

Confirmed: Date of MDR application put back by one year

2024-01-15T10:10:11+00:00April 28th, 2020|

Confirmed: Date of MDR application put back by one year Following our post on the 26th March regarding the European Council (EC) proposal to delay the Medical Devices Regulation (MDR - 2017/745) due to COVID-19, the proposal has been overwhelmingly backed by the European Parliament and was published in the Official Journal on [...]

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic

2024-01-15T10:07:43+00:00April 14th, 2020|

EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic In the wake of the on-going COVID-19 pandemic, the EMA has published a Question and Answers document which provides guidance to stakeholders on the implemented adaptations to regulatory framework that have been put in place to address some of the unprecedented challenges [...]

EC Propose Postponement of Medical Devices Regulation due to COVID-19

2024-01-15T10:07:00+00:00March 26th, 2020|

EC Propose Postponement of Medical Devices Regulation due to COVID-19 As of 25 March 2020, the European Commission (EC) announced that their services are working on a proposal to postpone the implementation of the Medical Devices Regulation (MDR – 2017/745) by one year (to May 2021). This announcement has been made following increasing pressure [...]

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