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 Team2023-03-31T13:12:41+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 [...]
Meditrial Editorial Team2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: Clinical Trial, Digital Health, Innovation, MHRA, UK|
UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in [...]
Meditrial Editorial Team2024-02-29T16:45:09+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The [...]
Meditrial Editorial Team2024-02-29T14:41:05+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) has issued an update proposal to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices. The proposal will be open for consultation untill 11 December 2020. The update includes advice [...]
Meditrial Editorial Team2024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, Innovation, USA|
The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the [...]
k.janecek2024-02-29T13:56:00+00:00October 9th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, European Union, Regulatory|
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) [...]
Meditrial Editorial Team2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: Clinical Trial, Digital Health, EMA, Europe, Innovation|
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]
k.janecek2024-02-01T16:41:27+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory|Tags: Canada, Clinical Trial, Covid-19, Regulatory|
Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic. New trialsTo reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical [...]
Meditrial Editorial Team2024-02-29T17:09:11+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA provided an update to the guidance on the conduct of clinical trials during COVID-19 pandemic. The update aims at providing "general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice [...]
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