Tag: medical device regulation
US FDA begins ‘real-time’ reporting of adverse event data
The US Food and Drug Administration (FDA) recently announced that it has begun daily publication of adverse event data from the FDA Adverse Event...
MHRA announces amends to UK medical device regulation
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today announced "important" new steps to secure access for patients to the latest medical...
ESMINT issues ‘call for experts’ to streamline EU medical device certification
The European Society of Minimally Invasive Neurological Therapy (ESMINT) has issued a call for experts in neurointerventions to work with notified bodies over the...
“The tables have turned”—US FDA regulation is becoming the envy of...
Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the...
UK MHRA adds capacity for medical device certification
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices.
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