adminMTE_04792024-02-29T13:50:15+00:00April 30th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory, UK|Tags: Covid-19, Europe, Regulatory, UK|
MHRA updated the guidance on the clinical requirements to consider for ventilators during COVID-19 emergency. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and [...]
k.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
k.janecek2024-02-07T16:09:22+00:00April 28th, 2020|Categories: Covid-19, USA|Tags: Covid-19, FDA, USA|
The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable face masks, such as surgical or medical masks, or [...]
adminMTE_04792024-02-23T16:59:16+00:00April 27th, 2020|Categories: Compliance, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic. Enforcement Policy for [...]
adminMTE_04792024-02-29T16:18:52+00:00April 22nd, 2020|Categories: Covid-19, UK|Tags: Clinical Trial, Covid-19, Helpline, UK|
UPDATED ON April 22nd, 2020 In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the management of clinical trials in response to the COVID-19 pandemic. "The MHRA will be as flexible and pragmatic as [...]
adminMTE_04792024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
adminMTE_04792024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
adminMTE_04792024-02-02T12:16:25+00:00April 17th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Digital Health, Europe, European Commission, European Union|
The EC and the EU Members States issued a toolbox for the use of mobile applications for contact tracing and alerting during the coronavirus pandemic. The toolbox is accompanied by guidance on data protection for such mobile app “Contact [...]
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