Tag Archives: Article 20

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Article 20

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

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…

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