Meditrial Editorial Team2023-03-31T09:37:46+00:00April 19th, 2021|Categories: Europe, MDR|Tags: Europe, European Commission, IVD, MDCG|
The European Commission Medical Device Coordination Group (MDCG) adopted a new standardization request for harmonized European standards in support of the MDR and IVDR after its initial standardization request was rejected last year.Contact Meditrial for a free consultation regarding your device! [...]
Meditrial Editorial Team2023-03-31T09:46:24+00:00April 12th, 2021|Categories: Compliance, Europe|Tags: Europe, European Commission, IVDR, MDCG|
The transition period to the new in vitro diagnostic regulation (IVDR) in the EU will last till next 26 May, 2022. In order to inform device manufacturers, the European Commission´s Medical Device Coordination Group issued a Q&A including information on [...]
Meditrial Editorial Team2023-03-31T11:05:13+00:00April 7th, 2021|Categories: Europe|Tags: Digital Health, Europe, European Commission|
The European Commission has established a new executive agency, the European Health and Digital Executive Agency (HaDEA) for digital and health projects. The agency is expected to help Europe emerge stronger from the COVID-19 pandemic.The new HaDEA will be responsible [...]
Meditrial Editorial Team2023-03-31T12:43:00+00:00March 31st, 2021|Categories: Clinical Trial, Compliance, Regulatory|Tags: Clinical Trial, ICH, International Council for Harmonisation, Regulatory|
The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data. Meditrial [...]
Meditrial Editorial Team2023-03-31T13:23:04+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 [...]
Meditrial Editorial Team2024-02-29T14:31:01+00:00March 24th, 2021|Categories: Clinical Trial, Europe, MDR, Switzerland|Tags: Clinical Trial, Europe, MDCG, Switzerland|
Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials in Switzerland. Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals and local [...]
Meditrial Editorial Team2024-02-29T16:54:30+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, RWE, USA|
The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption [...]
Meditrial Editorial Team2023-04-21T09:14:17+00:00March 15th, 2021|Categories: Clinical Trial, Europe, MDR, Software|
The European Commission Medical Device Coordination Group has issued a Q&A document on custom made devices. The document includes the definition of custom made device, examples of eligible and non-eligible devices and MDR-related procedures. Contact Meditrial to know how we [...]
Meditrial Editorial Team2023-04-21T09:20:12+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 [...]
Meditrial Editorial Team2023-03-31T13:15:38+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 [...]
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