Background to the Committee on the Safety of Devices (CSD)
The Committee on the Safety of Devices (CSD) was formed to advise Ministers and to complement the work of the MHRA (Devices sector) formerly the Medical Devices Agency.
The Committee was first set up in April 2001 and the full Committee meet two or three times a year.
Remit of Committee
The main aim of the Devices sector of the MHRA is to protect public health and safeguard the interest of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union. The remit of the Committee is to support this aim by giving advice on a range of device related initiatives. Recommendations can be made by the committee membership but as specific decisions are not taken by the CSD membership there is no need to have these independently reviewed or audited.
Code of Practice
The work of the Committee must remain confidential at all times. There could be serious consequences to industry if any leaks occurred from committee meetings. Members are all required to sign a declaration of interests form stating whether they have any interests in the medical devices industries.
CSD Code of Practice
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Terms of reference
The terms of reference of the CSD are to:
- take a strategic view of initiatives to make medical devices and their use safer and more effective
- offer advice on the development of device related policies
- advise on the format and targeting of the MHRA’s communications with the Health Service and
- be part of the Agency Quality Assurance System.
Minutes of meetings
The minutes of meetings are circulated to members after approval by the Chair within two weeks of meetings. Following circulation of the minutes to members, an edited version is placed on the MHRA's website.
There is no annual report.
Ad hoc groups and meetings
CSD members may be required to participate in ad-hoc groups and carry out pieces of work, often to short deadlines, as the need may arise.
Contacting the CSD
Members of the CSD can be contacted directly by members of staff from the Devices devision when specific advice relating to the use of a device and / or clinical issues relating to a device are required and MHRA Devices Clinical are unable to provide sufficient detailed information.
The advice may be required:
- as part of an adverse incident investigation
- in relation to an enquiry
- in relation to a compliance matter.
The relevant member of the CSD can be contacted by telephone or in writing (email or post). The chosen method may depend on the urgency of the request.
Details of areas of potential conflicts of interest for members of the CSD are included with the individual's contacts details.
Compliance with the Data Protection Act 1998
In order to comply with the Data Protection Act 1998 Devices Clinical will inform each member of the CSD / Register of Experts (RoE) what information we are holding and why.
Members are informed on joining the CSD annually or if MHRA intend to use the information for any purpose other than that for which it was originally obtained. Members are also informed that the validity / usefulness of the information is being monitored.
Committee membership
The Committee comprises 23 members from all healthcare backgrounds and includes two (2) lay members. Members are appointed for a four (4) year period and can then re-sit for a further four (4) years if they wish.
All appointments are made through the Appointments Commission.
Meetings
The full CSD committee meet three times a year. At present these meetings are ‘closed’. They may be ‘open’ meetings in the future.
Individual members meet on specific topics as needed.
The Chair meets the Clinical Director weekly.
Remuneration
The members are unpaid but receive an attendance fee and expenses. In addition, members that undertake clinical investigations receive a one off payment to carry out the investigation. Audits normally take between 10 -12 hours per person.
Meeting dates for 2011/12
The March 2011 meeting was cancelled and so no minutes were produced.
| Date | Location |
| 7 July 2011 | R-T - 501 and 502, Buckingham Palace Road |
| 3 November 2011 | R-T - 501 and 502, Buckingham Palace Road |
| 1 March 2012 | R-T - 501 and 502, Buckingham Palace Road |
| 5 July 2012 | R-T - 501 and 502, Buckingham Palace Road |
| 22 November 2012 | R-T - 501 and 502, Buckingham Palace Road |
Latest documents for the Committee on the Safety of Devices
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03 Nov 2011 | Committee on the Safety of Devices Meeting - 3 November 2011
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07 Jul 2011 | Committee on the Safety of Devices Meeting - 7 July 2011
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19 Nov 2010 | Committee on the Safety of Devices Meeting - 19 November 2010
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22 Jul 2010 | Committee on the Safety of Devices Meeting - 22 July 2010
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25 Mar 2010 | Committee on the Safety of Devices Meeting - 25 March 2010
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05 Nov 2009 | Committee on the Safety of Devices Meeting - 5 November 2009
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09 Jul 2009 | Committee on the Safety of Devices Meeting - 9 July 2009
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06 Mar 2009 | Committee on the Safety of Devices Meeting - 6 March 2009
(48Kb)
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28 Nov 2008 | Committee on the Safety of Devices Meeting - 28 November 2008
(156Kb)
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11 Jul 2008 | Committee on the Safety of Devices Meeting - 11 July 2008
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