Mr. Pat O'Mahony:

I am very happy to deal with Senator Burke's query because all of the work in which we are currently engaged at a very high level in Europe is about having a common system across Europe. Dr. MacAleenan has recently been appointed to the management board of an international body on medical devices. We are very pleased about that, as there are just three European nominees - one from France, one from Germany and one from Ireland.

If a product is coming in from outside Europe it must still have a CE mark in order to come onto the market in Europe, which requires the company to submit the file to a notified body. The notified body has the authority and the power to carry out inspections, no matter where the plant is located.

On the question of putting any industry here at an advantage or a disadvantage, that is a fundamental part of free trade in Europe and whatever rules apply here have to apply right across Europe.