adminMTE_04792024-02-29T17:13:19+00:00June 9th, 2020|Categories: Covid-19, Regulatory, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued "guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the [...]
k.janecek2024-02-07T15:50:33+00:00June 9th, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, Regulatory|
The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The update follows the delay of implementation of the MDR by one [...]
adminMTE_04792024-02-29T14:18:56+00:00June 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Spain|
Good news from Spain! Our monitors informed us about the restart of onsite monitoring visits as of today June 8th, 2020 after the break imposed by the COVID-19 emergency. Meditrial is closely monitoring the situation in all countries to restart [...]
adminMTE_04792024-02-29T16:23:25+00:00June 8th, 2020|Categories: Covid-19, Regulatory, UK|Tags: Covid-19, Digital Health, UK|
MHRA provided advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic. Standalone software and apps that meet the definition of a medical device are required to be CE [...]
k.janecek2024-02-29T16:31:53+00:00June 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, UK|Tags: Clinical Trial, Covid-19, Regulatory, UK|
The MHRA updated its Guidance for industry on flexible approaches to regulation they are taking during the COVID-19 outbreak. In the last update from 5th June 2020, the Agency added information on audits of Notified Bodies and manufacturers in [...]
adminMTE_04792024-02-01T16:59:23+00:00June 5th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Free Webinar|
FREE WEBINAR, JOIN US! WHEN: JUNE 10, 5 PM CET (Milan time) - Italian language Register for free! WHY YOU SHOULD PARTICIPATE: This webinar offers a training opportunity for more than 1000 Italian companies facing the challenge for the [...]
k.janecek2024-02-29T17:18:32+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The US Food and Drug Administration (FDA) updates its guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The Agency added information about electronic signatures for informed consent and provided clarification about remote assessments during [...]
adminMTE_04792024-02-29T15:21:59+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, UK|
The MHRA issued a guidance on the 3D printing of medical devices or component parts during COVID-19. The requirements manufacturers need to meet when 3D printing will depend on whether the item is a medical device, or a piece [...]
adminMTE_04792024-02-29T15:25:55+00:00June 3rd, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, UK|
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched Yellow Card, a dedicated site for reporting COVID-19 related adverse medical device incidents and side effects from medicines. You can report on Yellow Card if: a medicine causes side [...]
adminMTE_04792024-02-26T10:55:19+00:00June 2nd, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA|
The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or [...]
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