Meditrial Editorial Team2024-02-02T10:53:33+00:00May 28th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, Europe|
The European Medicine Agency (EMA) encouraged collaboration between EU researchers on high-quality, multi-center observational studies of COVID-19 treatments and vaccines. High-quality observational research of real world data collected during the pandemic can be an important complement to the results [...]
Meditrial Editorial Team2024-02-29T13:53:58+00:00May 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Netherlands|
The Central Committee on Research Involving Human Subjects (CCMO) published a document with the conditions for the (re)start of studies in clinical research units. The document foresees a step-by-step relaxation of the restrictive measures. This makes it possible to [...]
Meditrial Editorial Team2024-02-07T16:13:06+00:00May 25th, 2020|Categories: Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published a guidance describing how medical device manufacturers should notify CDRH of shortages during the COVID-19 emergency. This is a new reporting requirement for medical [...]
Meditrial Editorial Team2024-02-26T09:10:23+00:00May 25th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day [...]
Meditrial Editorial Team2024-02-29T14:38:43+00:00May 22nd, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Clinical Trial, Covid-19, Europe, European Commission, Regulatory|
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021. Moreover, the Commission issued guidelines explaining the process and requirements [...]
Meditrial Editorial Team2024-02-26T11:15:21+00:00May 20th, 2020|Categories: Europe, Regulatory, Western Europe|Tags: BfArM, Clinical Trial, DIMDI, Europe, Germany, Regulatory, Western Europe|
DIMDI (Deutsche Institut für Medizinische Dokumentation und Information) and BfArM (Federal Institute for Drugs and Medical Devices) will join to become one agency on May 26th, 2020. Once DIMDI is merged into BfArM, the name that has been in [...]
Meditrial Editorial Team2024-02-29T16:29:24+00:00May 20th, 2020|Categories: Compliance, Covid-19, UK|Tags: Covid-19, MHRA, Regulatory, UK|
MHRA issued update to regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment). Contents Antimicrobial hand sanitisers and gels Face masks Gloves Offers to supply or donate healthcare equipment to the NHS/healthcare providers [...]
Meditrial Editorial Team2024-02-02T11:50:42+00:00May 19th, 2020|Categories: Covid-19, Europe, Regulatory|Tags: Covid-19, EMA, Europe, Regulatory|
The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic [...]
Meditrial Editorial Team2024-02-01T15:08:04+00:00May 19th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: Austria, Clinical Trial, Covid-19, Europe|
The Austrian Federal Office for Safety in Health Care (BASG) updated its FAQ with new information related to the communication with the Federal Office and the withdrawal of measures at the end of the COVID-19 pandemic. Communication with the [...]
Meditrial Editorial Team2024-02-26T16:45:36+00:00May 15th, 2020|Categories: Clinical Trial, Compliance, MDR, Regulatory|Tags: Clinical Trial, Europe, MDCG|
The European Commission’s Medical Device Coordination Group (MDCG) issued a guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the MDR. The guidance applies to: premarket clinical investigations of non-CE marked devices, premarket [...]
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