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 [...]
Meditrial Editorial Team2024-02-29T16:50:47+00:00September 25th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: FDA, Regulatory, USA|
The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. The standard is recognized [...]
Meditrial Editorial Team2024-02-29T16:38:59+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: Clinical Trial, Digital Health, FDA, Regulatory, USA|
The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including [...]
Meditrial Editorial Team2020-08-31T15:11:17+00:00August 31st, 2020|Categories: Europe, MDR, USA|
With the MDR, EUDAMED will act as central repository of information to lay the foundation for collaboration, transparency and interaction of all parties, namely the new European databank for medical devices and in vitro diagnostic devices. EUDAMED will have several [...]
k.janecek2020-08-24T08:31:47+00:00August 24th, 2020|Categories: Compliance, Europe, MDR, Regulatory|Tags: Europe, European Commission, European Union, MDR, Regulatory|
On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach [...]
Meditrial Editorial Team2024-02-29T16:58:13+00:00August 17th, 2020|Categories: Clinical Trial, Compliance, USA|Tags: FDA, Regulatory, USA|
The FDA issued the first two device-specific guidances drawing performance criteria to support 510(k) clearance via the new pathway. The FDA had previously proposed an alternate safety and performance based pathway for certain well-understood medical devices. The two final [...]
Meditrial Editorial Team2024-02-29T16:01:48+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, MHRA, UK|
MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you [...]
Meditrial Editorial Team2024-02-29T17:10:45+00:00August 13th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid COVID-19. Meditrial is there to help! - Reach out to us for any kind of assistance in regard of [...]
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