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Brexit and the changes to medical device regulations coming in 2021

The United Kingdom’s exit from the European Union has had far-reaching ramifications for a wide range of industries, including medical device manufacturing. If you’re a medical device firm selling – or looking to sell – into the UK, significant changes are coming in January that can have a major impact on your plans. From January 1, 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are...

IVDR: What You Need to Know about Europe’s Changing IVD Market

The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this directive, all products of all classes that stay on the market after May 26, 2022 must be reassessed for IVDR compliance to ensure that those products are fit for purpose and safe to use. There is no automatic pass granted based on the...

FDA Cracking Down on Poor Performing EUA Tests

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.” Since February 4, 2020, FDA has approved 204 Covid-19 tests...