Proposed Legislation to Regulate Distributors of Medical Devices Notice of Public Consultation
The Minister for Health and Children, Ms. Mary Harney T.D., proposes to introduce legislation to regulate distributors of medical devices. The Minister would welcome the views of the public and interested parties on the following matters
- Registration of distributors with the Competent Authority for Medical Devices – The Irish Medicines Board
- Requirements for record keeping by Distributors and Retailers of medical devices to ensure a full system of traceability and capability to react in the event of recalls/withdrawals or field safety corrective actions.
- Requirements to ensure distributor’s have suitable facilities, personnel and equipment to maintain medical device quality during storage, transport and distribution, and to enable the conduct of an effective recall/withdrawal or field safety corrective action
- Requirements to ensure medical devices are CE marked and meet the mandatory labelling requirements when supplied.
- Requirements for maintaining a quality system in medical device distribution operations to an appropriate standard.
- Possibility of fees being charged to distributors of medical devices by the Competent Authority for Medical Devices, The Irish Medicines Board.
- Enforcement measures to allow Irish Medicines Board to suspend / revoke a distributors registration when appropriate.
Submissions should be forwarded by post to Distributors Consultation, Medical Devices Unit, Department of Health and Children, Hawkins House, Dublin 2 or by e-mail to medicaldeviceconsultation@health.irlgov.ie
Closing date for receipt of submissions is 5:30 p.m. on 9 July 2010
Please note the following:
- It is the responsibility of interested parties to ensure that their e-mail or submission is received within the Department by the above mentioned deadline.
- Any submission received is subject to the Freedom of Information Act 1997, as amended.
