We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Manufacturers do not need to submit a medical device report (MDR) to the FDA when information about the event would cause a person qualified to make a medical judgment to reach the conclusion that the device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to death or serious injury if it were to recur. Read More
The European Commission aims to increase the availability of notified bodies and designate EU reference laboratories as “essential actions” needed to ensure that the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) can take effect as planned on May 26, 2022. Read More
CellEra has received a warning letter from the FDA for not keeping written records of oral complaints about its drug-treated sterile wound dressings and not establishing a procedure to handle either oral or email complaints. Read More
The European Commission has ordered U.S. companies Illumina and Grail to keep their organizations separate and look into alternatives to Illumina’s planned $8 billion acquisition. Read More
Australia’s Therapeutic Goods Administration (TGA) is suing a medical device importer and its executive officers for the alleged unlawful importation of surgical face masks. Read More
The Advanced Medical Technology Association (AdvaMed) has developed a special code of ethics to govern dealings with healthcare professionals in India. Read More