Austria: medical device and IVD clinical trials submission process changes during transition to MDR

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

2021-04-22T10:58:02+00:00April 22nd, 2021|Clinical Trial, Europe, MDR|

EU: MDCG issued a guidance on standardization for medical devices

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

2021-04-19T08:47:50+00:00April 19th, 2021|Europe, IVD, MDR|

EU: The MDCG informs on how to handle class D IVDs during transition to new regulation IVDR

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

2021-04-12T09:14:08+00:00April 12th, 2021|Compliance, Europe|

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

2021-04-07T13:25:28+00:00April 7th, 2021|Europe|

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

2021-03-31T13:43:11+00:00March 31st, 2021|Clinical Trial, Compliance, Regulatory|

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

2021-04-01T09:46:18+00:00March 30th, 2021|Europe, Innovation|

Switzerland: New requirements and changes to authorization practice as of May 2021

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

2021-03-24T16:13:05+00:00March 24th, 2021|Clinical Trial, Europe, MDR, Switzerland|

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.

2021-03-19T10:03:34+00:00March 19th, 2021|Clinical Trial, USA|

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

2021-03-05T09:56:23+00:00March 5th, 2021|Compliance, Europe, Uncategorized|
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