Terms of Reference
- To actively support the Association’s strategy and strategic direction.
- To provide a forum for discussion and clarification of identified medical device issues which may arise (from Association members, existing or proposed legislation or guidelines), and to assist the Association to play an active rôle in any consultative process related to medical device matters.
- To promote effective liaison and provide informed opinion to regulatory bodies on medical device matters.
- To contribute regularly to the Association’s publications in order to communicate to Association members up-to-date information concerning medical devices and committee activities.
- To contribute to seminars, meetings or training courses, as and when necessary, in conjunction with other committees as appropriate.
- To co-opt Association members and non-members, as and when appropriate, to handle issues where input from other disciplines and / or specific expertise may be beneficial.
- As and when required, prepare reference documents or review and comment upon published papers of medical device interest.
- To formulate proposals for presentations, course or workshops under the direct organisation of the Association in conjunction with other interested and mutually acceptable organisations and to set up sub-groups or working parties with responsibility for implementing the proposals.
Expectations of Medical Device Committee Membership
The medical device Committee is composed of volunteers willing to contribute their time, experience, knowledge and efforts for the benefit of the organisation and its members. Medical device Committee membership requires commitment and dedication.
The medical device Committee is committed to providing the latest information on; international regulatory laws, standards and guidelines; intelligence across the discipline; and information on professional developments. Members of the Committee are therefore expected to have sufficient expertise in quality and medical devices and capacity to actively contribute to the knowledge base of the organisation.
The following is a list of expectations of medical device Committee membership:
- Attendance at a minimum of three face-to-face Committee meetings per annum
- Willingness to host Committee meetings (approx once every two years) if practicable.
- contributions to specialist meetings and training courses organised by the Association, the Committee and relevant professional organisations
- Contributions to working parties on topics of interest to the members
- Input of knowledge and experience to answer members’ questions
- Support in the organisation, planning and running of Association meetings and conferences
- Liaison with external organisations such as, but not limited to, ICR, JSQA, SQA.
- Liaison with other committees, groups, working parties and international members
- Contribute articles to Quasar and other RQA publications
- Contribute to preparation for MHRA and other Competent Authority Consultative Committee meetings
- Liaison with Notified Bodies
The structure of Committees is described in Document POL/001, Policy for the Organisation of Committees.
In addition to the Chairman and Secretary, other committee members will have specific responsibilities including:
- Programme Committee liaison for Association’s annual and international meetings;
- Co-ordination of the Committee’s regular contribution to Quasar;
- Updating the medical device section of the Association’s website;
- Liaison with other Association committees;
- External liaison as a member of the External Liaison Group (See CTR/011 – Terms of Reference of the External Liaison Group);
- Review of Committee minutes (the review of other committee’s minutes will be allocated to a specific committee member);
- Responsibilities for specific projects will be allocated as and when required e.g., for the organisation of specialist meetings/training days.
- Monitoring or moderating the Medical Device Discussion Forum on the RQA website
- Co-ordinating the committee’s planned training events
- Monitoring committee budget as allocated by the Association
- Monitoring and updating the regulatory roadmap
All members will be expected to actively contribute to the activities of the medical device Committee. The medical device Committee aims to meet approximately four times per year.