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 [...]
Meditrial Editorial Team2024-02-29T17:06:35+00:00August 3rd, 2020|Categories: Clinical Trial, Software, USA|
The FDA has recently published the user fee amounts which will be collected from medical device manufacturers in fiscal year 2021. Meditrial is the partner for medical device manufacturers in the US. Reach out to Meditrial for clinical or [...]
Meditrial Editorial Team2024-02-29T16:48:12+00:00July 29th, 2020|Categories: Clinical Trial, Software, USA|Tags: FDA, USA|
The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions. Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as [...]
Meditrial Editorial Team2024-02-29T16:40:22+00:00July 23rd, 2020|Categories: Clinical Trial, Compliance, USA|Tags: Covid-19, FDA, USA|
The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden. Meditrial has extensive experience on regulatory matters relating to medical device [...]
Meditrial Editorial Team2024-02-29T14:40:29+00:00July 20th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR|Tags: Clinical Trial, Europe, European Commission, MDCG, MDR|
The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency [...]
Meditrial Editorial Team2024-02-02T11:58:44+00:00July 13th, 2020|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Europe, European Commission, USA|
The European Commission together with the European regulatory agencies EMA (European Medicines Agency) and HMA (Heads of Medicine), released a statement to urge sponsors to comply with clinical trials rules after Brexit. The deadline for compliance is 31st December [...]
Meditrial Editorial Team2024-02-29T16:53:39+00:00July 13th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020. The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a [...]
Meditrial Editorial Team2024-02-29T15:14:45+00:00July 8th, 2020|Categories: Clinical Trial, Europe, UK|Tags: Clinical Trial, IRAS, UK|
On 2 June 2020 changes were introduced in the Integrated Research Application System (IRAS) to the way amendments are notified to Research Ethics Committees and NHS/HSC in the UK: Project-based research should now prepare amendments using the Amendment Tool. Amendments [...]
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