State Board Vacancies – Advisory Committee for Medical Devices of the Irish Medicines Board
Advisory Committee for Medical Devices of the Irish Medicines Board
In accordance with the Government’s recent decision to widen the opportunity for appointment to committees of State Bodies, the Minister for Health, James Reilly TD, invites expressions of interest from suitability qualified and experienced persons interested in being appointed to fill a vacancy that has arisen on the Advisory Committee for Medical Devices of the Irish Medicines Board.
The Irish Medicines Board (IMB) is the regulatory authority for human and veterinary medicines, medical devices and cosmetics in Ireland. In addition, the IMB is responsible for the implementation of EU and national legislation relating to Blood and Blood components and for Tissues and Cells. The IMB, formerly the National Drugs Advisory Board (NDAB), was established on a statutory basis by the Irish Medicines Board Act in 1995.
The mission statement of the IMB is:
‘to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products’
The IMB is responsible for the regulation of medical devices on the Irish market. The range of products types and technologies of medical devices is very wide including a range from walking frames, syringes and wound dressings through pregnancy tests to higher risk devices like replacement heart valves, implantable cardiac defibrillators, deep brain stimulators and radiotherapy machines.
There are three types of medical devices outlined in the legislation. They are as follows:
- General medical devices
- Active implantable medical devices
- In-vitro diagnostic medical device
Medical devices are divided into classes dependent on risk which can be low, medium and high risk.
The principle legislation covering medical devices is:
- Directive 90/385/EEC concerning Active Implantable Medical Devices (AIMDD) as amended
- Directive 93/42/EEC concerning General Medical Devices (MDD) as amended
- Directive 98/79/EC concerning In-vitro Diagnostic Medical Devices (IVDs)
The above Directives have been transposed into national law, as follows:
- S.I. No. 253 of 1994, European Communities (Active Implantable Medical Devices) Regulations, 1994 that became mandatory on 1st January 1995 as amended
- S.I. No. 252 of 1994, European Communities (Medical Devices) Regulations, 1994 that became mandatory on 14th June 1998 as amended
- S.I. No. 304 of 2001, European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001 that became mandatory on the 7th December 2003.
The general functions of the IMB, as defined by the IMB Act 1995 and subsequent legislation are:
- to ensure that medical devices available in Ireland comply with the Essential Requirements of the regulations and to participate in systems designed to achieve this throughout the European Union
- to appoint certification bodies in Ireland to act as ‘notified bodies’ for medical devices and perform appropriate conformity assessment of medical devices prior to them being placed on the market. The IMB oversee the notified bodies in Ireland on an ongoing basis.
- to review the scientific aspects of safety issues relating to medical devices reported through the vigilance system and overseeing investigations and related corrective actions conducted by medical device manufacturers for medical device product/safety issues
- to effectively communicate on device safety/product issues with users, manufacturers, European/international regulatory authorities and other relevant stakeholders
- to monitor the conformance of medical devices by conducting inspections at sites of manufacture of medical devices
- to authorise the use of medical devices for clinical research purposes
- to enforce the regulations for which it has responsibility
- if so requested, to advise the Minister or others concerned on such matters relating to medical devices as may be referred to it and are connected with the functions or activities of, or the services provided by, the Board
Details of Appointment
A vacancy is currently available on the Advisory Committee for Medical Devices (ACMD) of the Irish Medicines Board. In accordance with the requirements of the Irish Medicines Board Act 1995 as amended, members of the ACMD are appointed by the Government on the recommendation of the Minister for Health to advise the Board on matters relating to medical devices. The period of appointment will run from the date of appointment until 31 December 2015.
Meetings of the ACMD are normally held quarterly. Members will serve on a part-time basis and travel and subsistence allowances will be paid in accordance with approved public sector rates. Members of the ACMD do not receive remuneration.
Members of the ACMD are required to devote as much time to duties on the ACMD as is necessary for the proper and efficient discharge of their duties, and to comply with the relevant provisions of the Code of Practice for the Governance of State Bodies.
Type of persons required
Expressions of interest in serving as a member of the ACMD are being sought from persons with relevant skills and knowledge of the medical devices sector who would be prepared to contribute their skills and time. Experience and background in clinical specialties such as plastic and reconstructive surgery, interventional cardiology, cardiothoracic surgery, interventional radiology, or vascular surgery for the current vacancy would be particularly welcome/beneficial.
In particular, applicants must have no financial or other interests in any industry regulated by the Irish Medicines Board or any conflicts of interest likely to interfere with his or her ability to play a full part on the ACMD.
How to apply
Anyone interested in being considered for appointment as a member of the ACMD should submit an application form via www.publicjobs.ie/publicjobs/ together with detailed Curriculum Vitae not exceeding 3 pages.
The application process will consist of the following steps:
If you are already registered on www.publicjobs.ie/publicjobs/ you can log in using your username and password.
If you have not previously registered you will need to register your details, then you must go to “Choose a Job Category” on the left side of the screen. Click on “Membership of a State Board” and then click ‘Apply for this job’.
Step 1 -Download a PDF Application Form. This is an application form which you should complete and save to your PC.
Step 2 – Complete the Online Application Form. Most of this will be pre-filled from your registration profile. Then you will be asked to upload the PDF Application Form that you previously saved.
Step 3 – Attach a detailed CV not exceeding 3 pages.
By submitting an expression of interest the applicant accepts that appointments are made in the exercise of a statutory discretion, that the Minister is not obliged to consider the expressions of interest offered, that he is not confined to recommending an appointment from amongst those who have expressed an interest and is not bound by any statement set out in the notice.
Applications will be accepted up to and including Thursday 31st January 2013
We will treat all applications /expressions of interest confidentially and information will only be given to the appropriate personnel.