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In further Brexit fallout, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) said Sept. 1 that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023. 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
FDA inspections at four U.S. facilities revealed problems with design controls, medical device reporting, and corrective and preventive actions. Read More
FDA Commissioner Stephen Hahn said that the agency is resuming domestic inspections using a new risk assessment system developed in response to the pandemic. 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
Australia’s Therapeutic Goods Administration (TGA) said it is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies. Read More
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More