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The bipartisan sponsors called on fellow members to support or co-sponsor the Protect Medical Innovation Act of 2019, which would permanently repeal the tax. Read More
BSI said that when it initiated its contingency plan in August 2016, it “could not have foreseen the lack of political progress” toward a Brexit resolution. Read More
The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission. Read More
Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls. Read More
The proposal looks to keep up with the EU’s medical device regulations, which reclassified some categories of medical devices into higher risk classes. Read More
With a looming hard Brexit exit less than 60 days away, BSI is warning devicemakers that their CE certificates in the UK could become invalid if the UK and EU fail to negotiate an agreeable contract. Read More