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.
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Read More
The commission is delaying the implementation of the EU’s landmark Medical Device Regulation until May 26, 2021, and said regulators may use their discretion in allowing some certificates to temporarily lapse during this time. Read More
The spending bill grants the FDA $55 million in emergency funding for developing and reviewing medical countermeasures, vaccines, therapies and devices used in the battle against the COVID-19 pandemic. Read More
When asking for a meeting, sponsors should include product information, such as a description of the combination product and constituent parts and proposed indications, the agency said. Read More
Of particular concern are regulatory considerations for devices made for particular patients, which are covered under the TGA’s current custom-made definition that exempts the products from regulatory requirements, such as inspections and third-party certifications. Read More
Device manufacturers that have been denied a Certificate to Foreign Government (CFG) to export a product may file for a review of the decision in a process laid out in a new FDA guidance. Read More
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. Read More
Munich, Germany-based notified body TÜV SÜD has issued its first certificate for an in vitro medical device under the EU’s new In Vitro Medical Device Regulation (IVDR), marking the first IVDR certificate worldwide. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Read More
The FDA attempted to provide clarity on an HHS announcement over the summer that it would no longer require premarket reviews of laboratory-developed tests (LDTs), including LDTs for COVID-19, but the attempt just muddied the water further, according to attorneys at Ropes & Gray. Read More