adminMTE_04792023-03-31T13:23:04+00:00March 30th, 2021|Categories: Europe, Innovation|Tags: Digital Health, Europe, European Commission, European Union|
As COVID-19 keeps surging throughout many of the European countries, the EU and EU Commission launched EU4Health, the €5.1 billion funding program targeting EU countries, health organisations and NGOs. Aim of the program is to strengthen the resilience of post [...]
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_04792023-03-31T13:14:00+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 [...]
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 [...]
adminMTE_04792023-03-31T16:17:03+00:00November 17th, 2020|Categories: Compliance, Europe, Regulatory|Tags: Europe, European Commission, IVD, IVDR, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) released a guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). The guide provides industry a clarification on how to accurately classify diagnostics under the [...]
k.janecek2020-08-24T08:31:47+00:00August 24th, 2020|Categories: Compliance, Europe, MDR, Regulatory|Tags: Europe, European Commission, European Union, MDR, Regulatory|
On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach [...]
adminMTE_04792024-02-23T16:35:16+00:00August 11th, 2020|Categories: Compliance, Europe, Regulatory|Tags: Europe, European Commission, IVDR, MDCG, MDR, Regulatory|
The EU Commission’s Medical Device Coordination Group issued a guidance providing details on how notified bodies can reference Medical Device Single Audit Program audit reports when planning surveillance audits under the MDR or IVDR. Meditrial can help you to [...]
adminMTE_04792024-02-29T14:40:29+00:00July 20th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR|Tags: Clinical Trial, Europe, European Commission, MDCG, MDR|
The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency [...]
adminMTE_04792024-02-02T11:58:44+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 [...]
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 [...]
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