e.alvarado2022-07-05T08:49:15+00:00May 17th, 2022|Categories: Meditrial|Tags: Clinical Trial, Covid-19 vaccines, Drug Safety, Eudamed, PAES, PASS, POST-AUTHORIZATION STUDIES, SAFETY|
Over the course of two years of the pandemic, there have been heated debates about the safety and efficacy of the anti-Covid-19 vaccines. Even today, after more than 7 billion doses administered, issues continue to emerge about the available clinical [...]
k.janecek2024-02-26T16:46:14+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Eudamed, Europe, European Commission, European Union, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED of actors not subject to registration requirements under the Art. 31 Medical Device [...]
k.janecek2024-02-29T15:05:43+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Eudamed, Europe, IVDR, MDR, Regulatory|
The Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR) were published in Turkish Official Gazette No. 31499 on 2 June 2021. The Regulation, which is fully harmonized with European Union legislation, aims to improve [...]
adminMTE_04792023-04-21T09:20:12+00:00March 5th, 2021|Categories: Compliance, Europe|Tags: Eudamed, Europe, European Commission|
The European Commission announced the activation of the modules on UDI/device registration (second module) and on Certificates and Notified Bodies (third module) by September 2021. The first module on Actor registration is available since December 2020. EUDAMED will act as [...]
adminMTE_04792023-03-31T13:15:38+00:00March 1st, 2021|Categories: Europe, Regulatory|Tags: Eudamed, Europe, MDCG|
The MDCG issued a new guidance "to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions [...]
adminMTE_04792023-03-31T13:14:00+00:00February 15th, 2021|Categories: Compliance, Europe, MDR|Tags: Eudamed, Europe, European Commission, Regulatory|
The European Commission issued a new guidance explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database, expected to be fully rolled out by May 2022. "Legacy Devices are defined as Medical Devices, Active [...]
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