Oireachtas Joint and Select Committees

Wednesday, 25 September 2019

Joint Oireachtas Committee on Health

Brexit Preparations Update: Discussion

Mr. Jim Breslin:

Regarding what Mr. Sullivan said in his opening statement on medical devices and the notified bodies, which is the fact that not all the products that have UK notified bodies have got a new EU notified body behind them, we need to link that up with what the HPRA and the Department are saying, which is that the engagement of all of us is with those suppliers to become compliant. That is at the fore of the European Commission's position in saying that they must become compliant. However, in a situation where, Europe-wide, there are products that are required for healthcare and have public health implications and which up to the last day have a full CE mark signed off by a European member state, but on day one there is an issue over that, then we, the Minister and the HPRA have stated in Brussels that we need to solve that problem as part of a European system. It is not a supply issue but a regulatory one. We will be making our voice very clear. I understand why that decision will not be made until the end of this process. To make it six months out, one gives people no incentive to comply. However, we will have to examine it in that situation and look at the implications. Ireland and other member states will have a view on that and will be seeking to come up with a solution.

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