Even with the MDD firmly in place, new regulations are afoot. A current example comes from Ireland.
MPO Magazine reported that health officials in Ireland are soliciting feedback from medical device manufacturers and the business community on a proposal to regulate the distribution of medical devices.
Specifically, the legislation proposed by the Irish Minister for Health and Children covers issues such as:
- 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 labeling 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.
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