We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A key requirement of the policy is that the facilities must obtain a device manufacturing permit, which will raise the bar for the domestic industry. Read More
Conventional Foley catheters and cutaneous electrodes are the first two types of devices to get their own final guidances under the FDA’s new safety and performance-based pathway for 510(k) marketing clearance. Read More
The European Commission’s Medical Device Coordination Group (MDCG) said notified bodies can make use of Medical Device Single Audit Program (MDSAP) reports for audits under the EU’s medical device and in vitro diagnostics regulations. Read More
In a move likely to send ripples through the supply chain, President Donald Trump signed an Aug. 7 executive order that directs the federal government to obtain medical countermeasures and essential components domestically and reduce reliance on foreign firms. Read More
“These certificates are not evidence that the manufacturer has met the regulatory requirements and should not be taken as proof of such,” the MHRA warned. Read More
An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led to calls for major reforms at the agency due to its mishandling of safety concerns linked to pelvic mesh. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations. Read More
MedTech Europe is urging the European Commission and EU member states to publish guidance that clarifies that notified bodies may conduct audits virtually in place of on-site audits during the COVID-19 pandemic for new devices and in vitro diagnostics. Read More
If the device’s medical effectiveness could be compromised by its non-medical functions, the manufacturer should consider the possible adverse effects on the device’s medical performance, the agency says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations. Read More