adminMTE_04792024-02-02T11:53:30+00:00July 2nd, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA|
The European Medicine Agency (EMA) released a guidance to illustrate some points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials. "At this point in time it is not possible to provide general advice on [...]
k.janecek2024-02-29T14:46:51+00:00July 1st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory|
The US Food and Drug Administration (FDA) has published final guidance for unique device identification compliance dates for Class I and Unclassified Medical Devices. This immediately in effect guidance also clarifies the Agency policy concerning compliance dates for certain [...]
k.janecek2024-02-02T10:24:34+00:00June 30th, 2020|Categories: Clinical Trial, Covid-19, Eastern Europe, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Czech Republic, Regulatory|
The Czech Authority State Institute for Drug Control (SÚKL) updated its general recommendations respecting the current epidemiological situation with coronavirus regarding ongoing or not yet started clinical trials and the release of emergency measures of the government. This opinion [...]
k.janecek2024-02-29T17:02:19+00:00June 29th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The Food and Drug Administration (FDA) issued guidance on inspections of medical device establishments. The finalized document follows draft guidance issued on March 28, 2019, filling a requirement of the FDA Reauthorization Act of 2017 (FDARA). The guidance specifies [...]
adminMTE_04792024-02-29T17:05:07+00:00June 24th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA published a Q&A document to respond frequently asked questions from submitters and applicants on regulatory matters and issues relating to medical devices arising from the COVID-19 public health emergency. This guidance addresses the following: Meetings with Industry MDUFA [...]
adminMTE_04792024-02-26T09:26:25+00:00June 18th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The FDA issued guidance to provide sponsors with statistical advice in order to maintain trial integrity and reduce the impact of the COVID-19 emergency on clinical trials conduct. This new document follows the agency’s guidances on the conduct of [...]
k.janecek2024-02-29T10:16:35+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: Europe, Expert, Innovation, Regulatory, Switzerland, Venturelab|
Dr. Monica Tocchi, CMO and Founder of Meditrial joined the Innosuisse Start-up Training program designed by Venturelab, as a member of their Expert panel. The panel is composed of successful founders, leading academic and industry partners that bring the [...]
adminMTE_04792024-02-26T16:44:18+00:00June 12th, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Europe, European Commission, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) released guidance about the process for transitioning CE certificates for devices carrying ancillary substance which could be considered a medicinal product and those incorporating animal tissues to the MDR. Ancillary substances [...]
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 [...]
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