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 [...]
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 [...]
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_04792024-02-29T14:18:56+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 [...]
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.janecek2024-02-29T13:51:45+00:00June 2nd, 2020|Categories: Europe, Regulatory, Western Europe|Tags: Clinical Trial, Germany, Regulatory|
*** Deutsche Sprache unten *** MPG Basic Course for Investigators, Deputies and Members of the Clinical Study Group - NEW at the Meditrial Academy Berlin The MPG basic course based on the recommendations of the German Federal Medical Association [...]
k.janecek2024-02-29T14:13:21+00:00May 29th, 2020|Categories: Covid-19, Europe, Regulatory, Western Europe|Tags: Covid-19, Regulatory, Spain|
The Spanish Agency of Medicines and Medical Devices (AEMPS) moved to May 25th, 2021 the deadline for changing the labelling and instructions for use of medical devices due to Brexit. This decision aims at allowing manufacturers to face the [...]
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