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 [...]
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 [...]
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_04792024-02-02T10:53:33+00:00May 28th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
The European Medicine Agency (EMA) encouraged collaboration between EU researchers on high-quality, multi-center observational studies of COVID-19 treatments and vaccines. High-quality observational research of real world data collected during the pandemic can be an important complement to the results [...]
adminMTE_04792024-02-29T13:53:58+00:00May 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Netherlands|
The Central Committee on Research Involving Human Subjects (CCMO) published a document with the conditions for the (re)start of studies in clinical research units. The document foresees a step-by-step relaxation of the restrictive measures. This makes it possible to [...]
k.janecek2024-02-26T11:05:15+00:00May 26th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Europe, Italy|
Italy has been the gateway to Europe for the Coronavirus pandemic. The crisis has raised many questions about our vulnerabilities and strengths. After the emergency, what is our future? What is the new reality in the wake of the [...]
adminMTE_04792024-02-29T14:38:43+00:00May 22nd, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Clinical Trial, Covid-19, Europe, European Commission, Regulatory|
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021. Moreover, the Commission issued guidelines explaining the process and requirements [...]
k.janecek2024-02-29T15:17:32+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
On 21 May 2020, NIHR set out a framework to guide the restarting of NIHR research activities which have been paused due to COVID-19. Sponsors planning to restart trials or to initiate new clinical trials should take account of the principles [...]
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