Meditrial Editorial Team2024-02-02T11:58:44+00:00July 13th, 2020|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Europe, European Commission, USA|
The European Commission together with the European regulatory agencies EMA (European Medicines Agency) and HMA (Heads of Medicine), released a statement to urge sponsors to comply with clinical trials rules after Brexit. The deadline for compliance is 31st December [...]
Meditrial Editorial Team2024-02-29T15:14:45+00:00July 8th, 2020|Categories: Clinical Trial, Europe, UK|Tags: Clinical Trial, IRAS, UK|
On 2 June 2020 changes were introduced in the Integrated Research Application System (IRAS) to the way amendments are notified to Research Ethics Committees and NHS/HSC in the UK: Project-based research should now prepare amendments using the Amendment Tool. Amendments [...]
Meditrial Editorial Team2024-02-02T12:24:26+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 [...]
Meditrial Editorial Team2020-07-07T07:57:08+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 [...]
Meditrial Editorial Team2024-02-02T11:53:30+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 [...]
Meditrial Editorial Team2024-02-26T16:44:18+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 [...]
Meditrial Editorial Team2024-02-29T14:18:56+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 [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2026 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
