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”
Category: Medical device
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”
MDCG rolls out host of new guidances and updates with MDR looming
With 26th May fast approaching, the Medical Device Co-ordination Group (MDCG) has published three new guidances, two updated guidances and an implementation/preparedness plan for the incoming Medical Device Regulation (MDR). Read more “MDCG rolls out host of new guidances and updates with MDR looming”
COVID-19: Asia-Pacific Regulatory roundup
Catch up with the latest COVID-19 related regulatory interventions in the Asia-Pacific region. Read more “COVID-19: Asia-Pacific Regulatory roundup”
Revised medical device risk management standards and European regulatory requirements
Understanding the current expectations of a medical device risk management system is a critical element of meeting the new regulatory requirements. Read more “Revised medical device risk management standards and European regulatory requirements”
Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?
Smart medical devices, including medical tools, implants and pacemakers are being exposed to cyber-attack, due to vulnerabilities in their Bluetooth Low Energy (BLE) protocol. Read more “Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?”
UK government introduces post-Brexit medicines and medical device bill
In a post-Brexit overhaul, the UK government has introduced a human and veterinary medicines, clinical trials and medical devices bill, which could alter the regulatory framework at the end of the transition period. Read more “UK government introduces post-Brexit medicines and medical device bill”
FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic
The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US. Read more “FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic”
Would a Brexit deal hinder the UK medical device industry?
As the UK enters a transition period post-Brexit, there is evidence that a Brexit deal would require the medical device industry to abide by the EU Medical Device Regulation’s (MDR) tighter restrictions on development, thereby hindering the industry. Read more “Would a Brexit deal hinder the UK medical device industry?”