Recalls in the medical device industry are a business activity — not just something that the regulatory and quality teams do. Source: The GMP Letter

The European Commission has established common specifications for reprocessing single-use devices under the EU Medical Device Regulation. Source: The GMP Letter

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…

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…

FDA inspections at four U.S. facilities revealed problems with design controls, medical device reporting, and corrective and preventive actions. Source: The GMP Letter

The FDA issued warning letters to four device firms for violations that included unapproved tests and quality failures. Source: The GMP Letter

Australia’s TGA reported finding clear examples of harm caused by medical software in a review of medical device recalls. Source: The GMP Letter

FDA Commissioner Stephen Hahn said that the agency is resuming domestic inspections using a new risk assessment system developed in response to the pandemic. Source: The GMP Letter

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…

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. Source: The GMP Letter