Dr. Lorraine Nolan:

I will take the first part of that question about the regulatory processes. I will then pass over to colleagues from the HSE to talk about their ongoing review and evaluation of medical devices.

The Deputy is right that historically there has been a high dependence on the United Kingdom's regulatory activities, specifically certification of activities for medical devices in Europe. That being said, there is an issue of scale and numbers that may be impacted on. We are working very hard and have close dialogue with the European Commission on this issue and are hopeful a European solution can be achieved to have an ordered regulatory transition. If that is not achieved, at the end of the day, from the point of view of the safety of these devices and their quality and performance, just because regulatory compliance may fall as and from 31 October, it does not necessarily present any immediate risk to patients. In fact, from a regulatory viewpoint, given that the United Kingdom will be totally aligned up to 31 October, we have a full alliance. We will manage that situation on a national basis in terms of regulatory compliance because we will not allow it to compromise continuity of care for patients. To give reassurance on the regulatory process, it can be managed. Obviously, we will have to work with the industry to ensure it is working towards achieving that compliance and to making devices compliant as soon as possible. The position is changing as regards the regulatory basis in Europe. That is excellent in terms of the protection of public health because the framework coming into place is to raise the standards of patient protection. The notified body system in Europe is working through a process. Therefore, there is a timing issue with it which will sort itself out over time. It is unfortunate that Brexit and the introduction of the new regulatory changes have coincided, but I am confident that a European solution can be found.

I will pass over to colleagues in the HSE who will speak about the assessment work that has been taking place.