Mr. Pat O'Mahony:

I will ask Mr. Lynch to comment on the organ issue. Before doing so, I wish to pick up on an issue raised by Senator Jillian van Turnhout regarding the direction in which the process is heading with regard to medical devices and the joint assessment of notified bodies and whether we are making any progress in that regard. In the joint action on which we are working across Europe and in which the IMB is engaged and involved, there are joint assessments of all the notified bodies involved. The process is under way and by now assessments of more than 20 notified bodies have been made. Our notified body will be assessed before the end of the year. By the end of the year, all of the notified bodies which give pre-market approval for devices will have had a joint assessment. What this assessment brings about for the first time is that instead of just a local, national competent authority visit, there will be a visit by an expert from another competent authority in another country. There will also be a visit by an expert from the European Commission. Therefore, three separate groups will come to take part in a week-long assessment or whatever else is involved. This is already generating substantial improvements in the system and we will see it deliver for us over a period. Unannounced audits can also take place and they are happening. A range of other improvements are taking place in regard to communication and how the system is run. We are working hard on these. The position on medical devices will change, but we have a long way to go with regard to the regulatory environment for such devices.