Sufficient resources and regulatory expertise to perform its duties Contribution to scientific or regulatory innovation in the field of medical devices as demonstrated by development of guidance(s) in emerging technical and regulatory issues A capacity to contribute resources and expertise to the objectives of IMDRF A recognized commitment to the objectives of IMDRF demonstrated by implementation of IMDRF documents (work items) Roles Participates and Does not participate in the Does not participate in Does not participate in provides oversight in decision making process of the decision making the decision making the decision making IMDRF process of process of process and strategic Attends all and Only attends Only attends “open” “open” “open” direction of IMDRF sessions of the MC MC meetings MC meetings “closed” activities meetings Invited on a meeting May attend certain Attends all and Participates in IMDRF by meeting basis portions of the “open” sessions of Working Groups sessions of “closed” “closed” the MC meetings the MC meetings by including MC invitation of the MC teleconferences
Sufficient resources and regulatory expertise to perform its duties Contribution to scientific or regulatory innovation in the field of medical devices as demonstrated by development of guidance(s) in emerging technical and regulatory issues A capacity to contribute resources and expertise to the objectives of IMDRF A recognized commitment to the objectives of IMDRF demonstrated by implementation of IMDRF documents (work items) Roles Participates and provides oversight in the decision making process and strategic direction of IMDRF activities Attends all “open” and “closed” sessions of the MC meetings including MC teleconferences Does not participate in the decision making process of IMDRF Attends all “open” and “closed” sessions of the MC meetings Participates in IMDRF Working Groups Does not participate in the decision making process of Only attends “open” MC meetings Invited on a meeting by meeting basis Does not participate in the decision making process of Only attends “open” MC meetings May attend certain portions of the “closed” sessions of the MC meetings by invitation of the MC
imdrf-proc-171127-sop.docx