Meditrial Editorial Team2024-02-26T11:42:11+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 [...]
Meditrial Editorial Team2024-02-29T16:18:52+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 [...]
Meditrial Editorial Team2024-02-26T10:57:19+00:00April 21st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act. General provisions Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of [...]
Meditrial Editorial Team2024-02-26T16:52:20+00:00April 17th, 2020|Categories: Compliance, Covid-19, Europe, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance temporarily allowing postponement or remote audits of medical device manufacturers necessary for the re-certification of CE marking and related requirements. Normally, manufacturers must undergo on-site audits by Notified [...]
Meditrial Editorial Team2024-02-07T16:10:56+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. [...]
Meditrial Editorial Team2024-02-02T12:16:25+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 [...]
Meditrial Editorial Team2024-02-29T14:26:41+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 [...]
Meditrial Editorial Team2024-02-29T14:28:12+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 [...]
k.janecek2024-02-01T16:43:42+00:00April 15th, 2020|Categories: Clinical Trial, Compliance, Covid-19, Regulatory|Tags: Clinical Trial, Columbia, Covid-19, Regulatory|
In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 "By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19" , it [...]
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