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The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Read More
The European Commission (EC) launched a new registration module in December for Eudamed, the EU database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More
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 FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More
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