;   Medical Translation Insight: Ireland proposes new medical device regulations - ForeignExchange Translations

Ireland proposes new medical device regulationsEven 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.
Full details and information on how to provide input can be found on the web site for the Department of Health and Children.

ForeignExchange Translations provides specialized software translation and localization services to medical device companies. Contact us to learn more.


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