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 [...]
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 [...]
adminMTE_04792024-02-02T12:16:25+00:00April 17th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Digital Health, Europe, European Commission, European Union|
The EC and the EU Members States issued a toolbox for the use of mobile applications for contact tracing and alerting during the coronavirus pandemic. The toolbox is accompanied by guidance on data protection for such mobile app “Contact [...]
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 [...]
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