Switzerland: FOHP instructs on how to handle clinical trial applications during the transition to new regulation ClinO-MD

The new Swiss "Medical Device Regulation" (ClinO-MD) will come into force on 26.5.2021, at the same time as the EU MDR. The Federal Office of Public Health FOPH issued some instructions on how to handle applications during the transitions period to ClinO-MD. Meditrial and its

2021-03-25T11:54:20+00:00March 25th, 2021|Clinical Trial, Regulatory, Switzerland|

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 have direct connections with Investigators, hospitals  and local Ethics Committees. Please feel free to

2021-03-25T11:27:17+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|

EU: MDCG issues guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

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 for the exchange of information

2021-03-01T10:32:39+00:00March 1st, 2021|Europe, Regulatory|

EU: The European Commission issues a guidance on management of legacy devices in Eudamed

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 Implantable Medical Devices and In Vitro

2021-02-15T08:55:48+00:00February 15th, 2021|Compliance, Europe, MDR|

EU: EMA expands the use of remote source data verification in clinical trials

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 stated that rSDV would “only

2021-02-09T09:59:57+00:00February 9th, 2021|Clinical Trial, Covid-19, Europe|

UK: MHRA updates guidance on virtual manufacturing of medical devices

The UK MHRA has updated a guidance on virtual manufacturing of medical devices. "A virtual manufacturer is an organisation that fully sources its own named product from another company [...] which has designed and manufactured an identical UKCA/CE/CE UKNI marked product. By placing their own

2021-02-04T09:24:52+00:00February 4th, 2021|UK|

US: CDRH plans full launch of ASCA pilot program in 2021

The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business needs for medical device, in

2021-01-29T16:23:36+00:00January 29th, 2021|Regulatory, USA|
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