k.janecek2024-02-29T13:59:58+00:00May 1st, 2020|Categories: Covid-19, Europe, USA|Tags: Covid-19, Europe, Helpline, USA|
By Dr. Monica Tocchi, MD, PhD One million Covid-19 patients have returned to their homes after discharge from hospital. But are they fully healed? Why is this not being discussed amidst the crisis? It is a burning global health [...]
k.janecek2024-02-29T14:08:24+00:00April 30th, 2020|Categories: Covid-19, Europe, Regulatory, USA|Tags: Covid-19, Europe, Regulatory, USA|
Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during [...]
adminMTE_04792024-02-29T13:50:15+00:00April 30th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory, UK|Tags: Covid-19, Europe, Regulatory, UK|
MHRA updated the guidance on the clinical requirements to consider for ventilators during COVID-19 emergency. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and [...]
k.janecek2024-02-26T12:08:56+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, Europe, Regulatory|
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. 'The COVID-19 pandemic affects the whole world and the best way to fight it [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
k.janecek2024-02-07T16:09:22+00:00April 28th, 2020|Categories: Covid-19, USA|Tags: Covid-19, FDA, USA|
The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable face masks, such as surgical or medical masks, or [...]
adminMTE_04792024-02-23T16:59:16+00:00April 27th, 2020|Categories: Compliance, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued guidances to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides and non-invasive fetal and maternal monitoring devices during COVID-19 pandemic. Enforcement Policy for [...]
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: [...]
k.janecek2024-02-07T15:52:28+00:00April 24th, 2020|Categories: Covid-19, Europe, MDR, Regulatory|Tags: Europe, European Commission, MDR|
Medical devices can be sold for another year under the current regulatory framework based on the EU Medical Device Directive (93/42/EEC). The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2024 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
