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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
The FDA clarified its regulatory approach for multiple function devices in a final guidance that outlines the extra steps manufacturers of such products need to take. 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
A database of implanted devices would allow the long-term follow-up of patients and provide information on device safety and patient-reported outcomes, the report said. Read More
Among other questions, the lawmakers asked what resources the agencies are using to assess the extent of the scams and what actions they are taking against those involved. Read More
The agency noted in new guidance that COVID-19 and other factors are creating obstacles for labelers in meeting the UDI direct mark requirements for certain finished devices already manufactured, labeled and in inventory. Read More
“The medical technology industry would strongly encourage allowing ‘virtual audits’ when necessary and consider them as a tool to overcome challenges linked to the CE marking procedure when on-site audits cannot be performed,” MedTech Europe said. Read More