Article 20 of the Medical Device Directive delineates the requirements for “Confidentiality.” There are three takeaways from this edition: Under the Directive, reasonable attempts at confidentiality are required to be sustained; three categories of information are not protected under the confidentiality clause—registration, user, and certification information; and the best way an organization can protect itself in regards to the managing of proprietary information is through a well-documented policy augm…

Continue reading →