The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021. Meditrial manages several studies in Austria and has direct connections with investigators, hospitals and
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! With international presence and
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 how to handle class D
EU: Commission drives digital health by establishing new European Health and Digital Executive Agency
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 for the activations of
International Council for Harmonisation (ICH) to issue revision of E6 (R2) Good Clinical Practice in the fall of 2021
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 experts are at the forefront
EU: European Union and Commission launch EU4Health funding program to boost healthcare digitalization and make devices more accessible
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 COVID19 healthsystems and to promote
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 Ethics Committees. Please feel free to
US: FDA provides examples on real world evidence to support marketing applications for medical devices
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 (HDE), premarket approval (PMA) and more.
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 can support medical device manufacturers
EU: EUDAMED UDI/device registration and Certificates and Notified Bodies modules available by September 2021.
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 central repository of information to