Mr. Pat O'Mahony:

I am grateful to the members for the opportunity to answer a few questions. First, I made it very clear the previous times I appeared before the committee that as the competent authority for patient safety we were very unhappy with the situation with regard to medical devices at that time and how pre-market approval was operating. As Deputy Ó Caoláin said, it suffered a severe dent. Two things happened in response to that: one is the proposal for the new legislation, and the other is what is happening, as I have described, under the joint plan.

Mr. Barron has captured the issues on the legislation. In essence, we rely on the policy lead from the Department and it is still early days for the proposals. Much of what is required is captured in the legislation. To respond to the question about the scrutiny mechanism, it was in the Commission's proposal, which was that a certain percentage of files that would be looked at by the notified bodies would also be examined by another committee as a separate pair of eyes. The proposal as I understand it from the ENVI committee is that there is the scrutiny mechanism and a centralised committee looking at all high-risk devices. We still do not know where that debate will end.

From a competent authority perspective, whatever the outcome is along those lines that would increase protection for patients, that would be perfectly okay with us, and we will work within that system. There will be resource implications, but we will work within it. In the certain knowledge that legislation takes time, we are trying to make real progress on the joint plan in the meantime. Since we last met, as I described, all this stuff has been going on around joint assessments of the notified bodies. We identified before that the big weakness in the pre-market piece was the lack of consistency across notified bodies across Europe. As I said in the note, up to 20 countries have now had visitations. The joint visitation consists of the Commission, the national competent authority and experts from other competent authorities. It is a very rigorous review of the approach of the national authority and the notified body. They have targeted first of all the notified bodies involved with high-risk or class 3 devices. That has worked very well and progress has been made during the second half of this year, and a legislative basis is being provided now by the Commission to make that mandatory, which is very helpful.

With regard to unannounced inspections, the answer is that they are under way. Our own notified body, the NSAI, is doing that, and it is happening across Europe. With regard to the RAPEX system, we are also involved with cosmetics and others are involved with food in other areas, and the RAPEX system is in place for that. The Commission has in place a similar system for medical devices, which it is currently suggesting will remain as the system. It is similar to RAPEX but it has a different title and it operates in a different way, but it means that if an issue is notified in a country it will be disseminated throughout the rest of the competent authorities via this process.

I will make a quick comment on insurance. The new proposals make provision for a manufacturer's liability if the manufacturer goes bankrupt. It would have applied, for example, in the PIP case. There is also a requirement in the proposal for notified bodies to have specific insurance to cover their liabilities. The issue of health professionals such as surgeons does not seem to be addressed in the current proposal. The fundamental issues raised in the question about insurance are captured in the current Commission proposal. They are the main questions to which I needed to respond.