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Combination products marketed under a device application have up to 30 calendar days to submit an adverse event report for “serious” and “unexpected” events. Read More
France’s National Medicines Agency has established a pilot project to prepare for implementation of the new EU Medical Device Regulation and In Vitro Diagnostics Regulation. Read More
TGA said that manufacturers are responsible for assessing and managing the cyber security risks of their devices before they reach the market. Read More
The advertisement failed to mention contraindications for the product, including acute pelvic inflammatory disease or current behavior suggesting a high risk of pelvic inflammatory disease. Read More
The agency said that manufacturers seeking certification for new products or maintaining existing certification may be affected by notified bodies that do not intend to transition to the new MDR, such as Lloyd’s Register and QS Zurich AG. Read More
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020. Read More