Working Groups may be established by the Management Committee and operate under targeted mandates on specific activities identified in the IMDRF work plan.
Participation on Working Groups
Working Groups are constituted in terms of size and representation as determined by the Management Committee. Working Groups are responsible for developing technical documents, and would generally involve the participation of stakeholders that have significant involvement in the development, manufacture or use of medical devices including, but not limited to, regulated industry, international entities and associations, academia, patient and consumer groups, medical professionals, and other regulatory authorities.
Working Groups responsible for developing technical documents that involve the exchange of sensitive or confidential information, or involve the specific practices or procedures of the regulatory authorities, would be comprised exclusively of representatives from regulatory authority members. When Working Groups comprised of regulatory authorities only are formed, the Management Committee will provide a clear and transparent justification for the limitation of membership on these Working Groups.
Nomination of Members, including the Working Group Chair, must be endorsed by the Management Committee. If a Working Group is to include stakeholders, these stakeholders should be nominated/selected based upon their expertise in the specific subject matter and their ability to actively contribute to the activities of the Working Group.