adminMTE_04792024-02-26T11:42:11+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) issued on April 20th four technical documents covering cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER). Following, a short overview on the content of the guidelines: [...]
adminMTE_04792024-02-29T16:18:52+00:00April 22nd, 2020|Categories: Covid-19, UK|Tags: Clinical Trial, Covid-19, Helpline, UK|
UPDATED ON April 22nd, 2020 In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the management of clinical trials in response to the COVID-19 pandemic. "The MHRA will be as flexible and pragmatic as [...]
adminMTE_04792024-02-07T16:10:56+00:00April 17th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, USA|
The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The FDA has made a wide range of information regarding their activities available to the public on their COVID19 website. [...]
adminMTE_04792024-02-29T14:26:41+00:00April 16th, 2020|Categories: Clinical Trial, Covid-19, Europe, Switzerland|Tags: Clinical Trial, Covid-19, Europe, Switzerland|
The Swiss Federal Council issues a new regulation allowing marketing of devices that have not undergone a conformity assessment procedure. This will not exempt the manufacturer from proving performance of the device and essential requirement fulfilment. This exception is [...]
adminMTE_04792024-02-29T14:28:12+00:00April 16th, 2020|Categories: Clinical Trial, Covid-19, Europe, Switzerland|Tags: Clinical Trial, Covid-19, Switzerland|
The Swiss Federal Council temporarily suspends custom duties on import medical goods. Such measure was set out to ease the import of medical equipment such as masks, gloves, disinfectant, protective goggles to face COVID-19 emergency in the country. The [...]
adminMTE_04792024-02-07T16:07:23+00:00April 11th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR|Tags: Clinical Trial, Covid-19, Europe, MDR|
Few changes made and… review by Parliament announced on APRIL 16th! On April 7, 2020 the Presidency of Council of the European Union (EU) examined the European Commission (EC) proposal for MDR delayed application, including the urgent measures regarding devices [...]
k.janecek2024-02-26T11:53:42+00:00April 9th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
Today, the international regulators have published a report highlighting their reflections on the development of potential COVID-19 therapies, clinical trials, and compassionate use programs. The report presents the results of a virtual meeting from April 2nd, 2020 on COVID-19 [...]
k.janecek2024-02-02T11:24:14+00:00April 3rd, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
EU has updated their COVID-19 clinical trial guidance that was initially released on March 20, 2020. Version 2, published on March 27, includes the following key changes from version 1: Initiating new clinical trials The feasibility of starting a [...]
adminMTE_04792024-02-29T16:35:19+00:00March 31st, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, Helpline, USA|
While global markets are being impacted by COVID-19 pandemic, FDA issues various statements regarding measures to tackle the negative impact on industry and people. Following, we provide a summary of FDA recently introduced regulatory policies. March 31 The FDA [...]
adminMTE_04792024-02-01T16:54:53+00:00March 30th, 2020|Categories: Clinical Trial, Compliance, Covid-19|Tags: Clinical Trial, Covid-19|
PROTOCOL AMENDMENT: The submission of amendments and related documents, must be presented to MoH -INVIMA-, including the approval letter of at least one Research Ethics Committee. INVIMA will evaluate and issue a concept for these documents and provide a [...]
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