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Companies located outside the European Union (EU) need to designate an EU-authorized representative if they want to sell SARS-CoV-2 in vitro diagnostic devices in EU countries, the EU’s Medical Device Coordination Group (MDCG) has advised. Read More
The number of EU Notified Bodies empowered to certify devices for a CE mark or CE-in vitro diagnostic (IVD) mark has increased by two, to 27. Read More
In a final rule released yesterday, the FDA said that it will no longer publish its quarterly approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs) in the Federal Register. Read More
In observance of Martin Luther King Jr. Day, FDAnews Device Daily Bulletin Premium will not be published Monday, Jan. 17. The next issue will be published Tuesday, Jan. 18. Read More
When devicemakers conduct validation and verification testing, they look at two general types of data — continuous and discrete. Continuous or typical data essentially apply to performance requirements. Read More
Sweden’s Xvivo touted the success of its heart perfusion device used in the first successful transplantation of a genetically modified pig heart to a human. Read More