adminMTE_04792023-03-29T14:47:07+00:00January 12th, 2022|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: Compliance, Covid-19, Europe, Invitro diagnostic devices|
The MDCG 2022-1 Notice has been published It is addressed to manufacturers of SARS-CoV-2 IVDs based in a third country and who place or intend to place their in vitro diagnostics on the EU market. It highlights a number of common issues [...]
adminMTE_04792023-03-31T13:12:41+00:00February 9th, 2021|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, European Commission, Remote Source Data Verification, rSDV|
The European Commission and European Medicines Agency’s updated the guidance on managing clinical trials conducted during the COVID-19 pandemic by expanding the use and scope of remote source data verification (rSDV) in clinical trials. While previous versions of the guidance [...]
k.janecek2024-02-01T16:41:27+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory|Tags: Canada, Clinical Trial, Covid-19, Regulatory|
Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic. New trialsTo reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical [...]
adminMTE_04792024-02-29T17:09:11+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA provided an update to the guidance on the conduct of clinical trials during COVID-19 pandemic. The update aims at providing "general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice [...]
adminMTE_04792024-02-29T16:01:48+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, MHRA, UK|
MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you [...]
adminMTE_04792024-02-29T17:10:45+00:00August 13th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid COVID-19. Meditrial is there to help! - Reach out to us for any kind of assistance in regard of [...]
adminMTE_04792024-02-29T16:53:39+00:00July 13th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020. The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a [...]
adminMTE_04792024-02-02T12:24:26+00:00July 8th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Europe, European Commission|
The European Commission (EC) conducted a survey in order to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the EU and for which notified bodies [...]
adminMTE_04792020-07-07T07:57:08+00:00July 7th, 2020|Categories: Compliance, Covid-19, Europe|Tags: Covid-19, Europe, European Commission|
The European Commission launched the JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database. The objective of this database is to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices [...]
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 [...]
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