The Medicine and Healthcare Products Regulatory Agency (MHRA) have released a list of medical devices granted exceptional use applications during the pandemic. Read more “Exceptional use authorisations for medical devices during COVID-19”
Category: Medical device
Transitioning devices with ancillary substances to MDR
A guidance recently published by the Medical Device Coordination Group (MDCG) explains the process for transitioning CE certificates for devices containing an ancillary substance under the Medical Device Regulation (MDR). Read more “Transitioning devices with ancillary substances to MDR”
The latest update on the MDR, IVDR implementation timeline
The European Commission (EC) has updated its rolling plan for adopting implementing acts ahead of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Read more “The latest update on the MDR, IVDR implementation timeline”
Obtaining informed consent for clinical trials during COVID-19
The US Food and Drug Administration (FDA) have developed a new app which provides a suitable way of obtaining informed consent in an electronic format for both investigators and subjects. Read more “Obtaining informed consent for clinical trials during COVID-19”
South Korea adds renewal requirement for new medical device authorisations
South Korea’s Ministry of Food and Drug Safety (MFDS) have published revised guidance for medical device authorisations. Read more “South Korea adds renewal requirement for new medical device authorisations”
MDCG publishes five new guidances
The European Commission’s (EC) Medical Device Coordination group (MDCG) has posted five new guidances on clinical evidence for legacy devices, regulatory requirements for ventilators, post-market clinical follow-up (PMCF) plan and evaluation report templates, and clinical evaluation of equivalence to existing devices. Read more “MDCG publishes five new guidances”
When is a device exempt from a pre-market clinical consultation?
The Medical Device Coordination Group (MDCG) have issued a revised guidance on the criteria exempting medical devices from pre-market clinical evaluation consultations with expert panels. Read more “When is a device exempt from a pre-market clinical consultation?”
European Commission adopts one year delay to MDR
The European Commission (EC) has asked EU law makers to delay the implementation of the incoming Medical Device Regulation (MDR), which is due to apply from 26 May 2020. Read more “European Commission adopts one year delay to MDR”
CPAP device gains rapid MHRA approval for use in COVID-19
A Continuous Positive Airway Pressure (CPAP) device, which can help to keep coronavirus patients out of intensive care, has been created in under a week, and gained rapid approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “CPAP device gains rapid MHRA approval for use in COVID-19”
Expanding the availability of critical ventilator devices to fight COVID-19
With an urgent need for the rapid manufacture of life-saving ventilator systems for hospitals to fight the current pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA), along with their international counterparts, have outlined how they intend to expand the availability of such devices. Read more “Expanding the availability of critical ventilator devices to fight COVID-19”