Ireland Proposes Funding Model for Medical Device Regulatory Activities
Starting in 2016, medical devicemakers supplying or manufacturing products in Ireland would be subject to a proposed fee-based system to cover the cost of the Health Products Regulatory Authority’s market surveillance activities.
HPRA developed the system at the request of Ireland’s Department of Health, which had been providing the majority of the authority’s funding, according to a public consultation document announcing the proposal. It comes as health authorities in other European countries, including Austria, Germany, Portugal and Spain, have turned to user fees to recover the costs of their regulatory activities.
HPRA considers this a suitable approach in terms of equity and minimizing burden, in advance of a wider solution at the European level.
Taking company size into consideration, the proposed fee structure is as follows:
- Manufacturers with more than 150 employees would pay about US $33,000;
- Manufacturers with 50 to 150 employees would pay about US $27,500;
- Manufacturers with 15 to 49 employees would pay about US $16,500;
- Manufacturers with five to 14 employees would pay about US $5,500; and
- Manufacturers with fewer than five employees or turnover of less than US $557,800 would pay about US $275.
Other fees apply to distributors and authorized representatives for medical devices in Ireland. The fee for export certifications, also known as certificates of free sale, would rise to about US $275. As a result of this fee increase, HPRA says it will introduce an expedited service for issuing these certificates.