1. The Medical Devices Agency has a challenging set of targets and objectives for the coming year. Our strategy, set out recently in the five-year Corporate Plan, seeks to position the Agency as the leading Regulator in Europe and as an authority for medical devices worldwide. Above all it will ensure that the Agency gives the greatest possible support to the Government's quality agenda for the National Health Service and to the implementation of the NHS Plan. The purchase and use of medical devices will increase rapidly next year as part of the programme to re-equip and modernise the NHS and medical devices are set to play an increasingly important role in health care.
2. Our goal for 2001-02 is to improve the safe and effective use of medical devices throughout the health and social care services. We will be giving particular attention this year to devices used by patients at home and we will give all the support we can to securing the quality agenda for the NHS. We will do this through:
our strategy to improve post-market surveillance of medical devices,
underpinning the NHS controls assurance programme for devices,
aligning our evaluation programme to support the priorities of the NHS Plan,
introducing a series of training and educational initiatives for users of medical devices,
increasing the guidance we make available for users, and
improving the ways we communicate with users by enhancing our website and developing direct electronic links. 3. We will increase our dialogue with stakeholders, particularly patient groups, the professions and the medical devices industry. We will work with the UK medical devices industry to enhance its standing and profile and to ensure, through our control of clinical investigations, that the UK is a fertile environment for innovation.
4. Within the European Union MDA has taken the lead in the establishment of a Notified Oversight Group and has secured a review of the Medical Devices Directive 93/42. Over the coming year we will seek to ensure that the Directives focus more clearly on patients and users of devices. We want to secure some necessary changes in the operation of the Directives to benefit public health throughout Europe and to enhance confidence in the system, for example by encouraging more transparency consistent with the aims of freedom of information. We will also seek to ensure that European and international Standards programmes are prioritised to place patient care and the public health agenda at the forefront.
5. We expect to build on the commitment and expertise of all our staff, keeping their skills and knowledge up-to-date. During the past year the Agency was successfully re-accredited as an Investor In People. In the next year we will undertake further initiatives as part of the agenda for Modernising Government and the programme for Civil Service Reform. Key themes to be taken forward are leadership training, diversity, the management of stress and reduced dependency on long hours. We will also work with the Department of Health to improve the pay system so as to reward our staff for their work and achievements.
6. Quality assurance and business excellence are key issues for any regulatory authority. The Agency has set itself a demanding quality assurance programme. We will use the Business Excellence Model to assess the strengths and weaknesses of the Agency, and undertake further benchmarking exercises both with other UK Executive Agencies and internationally. We will also seek to evolve an outcome analysis quality assurance system.
7. This programme will be complemented by the establishment of a new external professional advisory committee structure in the Spring of 2001. The new Advisory Group will increase the quality of the Agency's advice. We want it to take a strategic view of initiatives to make medical devices and their use safer and more effective, to offer advice on the development of device-related policies, to advise on the format and targeting of communications with the Health Service and to be part of our quality assurance system.
8. The Corporate Plan records the new financial freedoms we have secured, in particular the opportunity to develop new revenue-generating operations in "Selling to the Wider Market". The Agency will be using this freedom to enhance its services to all stakeholders. It expects to develop a series of major conferences and new training initiatives, to explore new ways of packaging publications and to offer new support functions to other agencies and Government Departments.
9. The Agency is able to expand its activities in the coming year within its previously allocated budget as a result of increased efficiency and the use of the new financial freedoms. We look forward to playing a major part in raising healthcare standards both within the UK and internationally. Above all, MDA will place the patient at the centre of all it does.
