Tag Archives: Article 21

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

MDD – Article 21

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

Article 21 of the Medical Device Directive delineates the requirements for “Repeal and Amendment of Directives.” It is incumbent upon device manufacturers to ensure all of these changes have been captured and adequately addressed within your organizations. If your organization has not implemented these changes, Dr. D suggests you “Get er done.”

Continue reading