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The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Read More
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Read More
Brazil’s National Health Surveillance Agency (ANVISA) is expediting approvals for medical devices and in vitro diagnostics related to the COVID-19 pandemic. Read More
The UK’s Medicines and healthcare Regulatory Agency (MHRA) is focused on building diagnostic capability for COVID-19 infections and is ramping up testing facilities across the UK via partnerships with universities, research institutes, diagnostics manufacturers and companies like Amazon and Boots. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released new guidance for devicemakers on regulatory requirements for equivalent devices. Read More
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Read More
The agency is allowing laboratories to use tests they develop and validate before the FDA has issued an EUA for their test but will also allow states to authorize tests in some situations. Read More