Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market. Information After years of development and testing, bringing your medical device to market is an exciting achievement.  However, your work isn’t finished yet. Once your product is in the hands of the public, […]

There is a common misconception that only manufacturers need to comply with the Medical Device Regulation (MDR) 2017/745 and/or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) . However, MDR/IVDR defines the roles and the responsibilities of “Economic Operators” which includes Importers, Distributors, Authorized Representatives and Manufacturers. An Importer means any natural or […]