Ireland Developing New Medical Device Regulations

Ireland’s top health official is soliciting feedback from manufacturers and business leaders on a new proposal to regulate the distribution of medical devices.

The legislation from the Department of Health and Children covers various issues, including:

•The registration of distributors with the Irish Medicines Board;
•Requirements for record-keeping by distributors and retailers of medical devices to ensure traceability and capability during product recalls or field safety corrective actions;
•Requirements to ensure sellers have suitable facilities, personnel and equipment to maintain device quality during storage, transport and distribution, and to facilitate an effective product recall or field safety corrective action;
•Requirements to ensure medical devices are CE marked and meet mandatory labeling requisites;
•Requirements for maintaining a quality system in medical device distribution;
•Possible fees for sellers by the Irish Medicines Board; and
•Enforcement measures to allow the Irish Medicines Board to suspend or revoke a seller’s registration when appropriate.

Input on the proposed legislation can be emailed to: [email protected] or sent by traditional mail to: Distributors Consultation, Medical Devices Unit, Department of Health and Children, Hawkins House, Dublin 2 (Ireland). The department is accepting comments through 5:30 p.m. on July 9.

Ireland is home to more than 160 medical technology companies. These firms, according to the Irish Medical Devices Association, export 6.8 billion Euros ($8.4 billion U.S. dollars) worth of products worldwide annually. The industry employs 24,000 workers, the highest in all of Europe per head of population, according to the association. Exports of medical devices and diagnostics products represent 8 percent of Ireland’s total merchandise exports.