Dr. Lorraine Nolan:

To be honest, we would need another session to go into this in detail. First, the EMA has no role in respect of the regulation of medical devices. It is a notified body system. It is a decentralised approach. Our organisation does not issue certificates for devices. They are issued by certification organisations throughout Europe.

We are transitioning to a new regulatory regime, which enhances the standard those notified bodies have to comply with. From the notified body viewpoint, one can imagine that their quality systems and resourcing are all being elevated in standard. That takes time and is the complexity for them when they are being asked to accept certification activities that were previously conducted by the UK in order to bring them in. They are struggling with capacity issues in this. It can be managed, which is the one thing to say about the regulatory system. Mr. Breslin has outlined that we are confident that a European solution can be found. If it cannot be found at a national level we can make decisions as a regulator to work with those companies to bring them into compliance. I have spoken about the fact of the risk that these present. It is the same regulatory system on 31 October as on 1 November. We will do whatever it takes to keep continuity of care going and will work with the companies. There is a risk over time that, commercially because of uncertainty, that may change in terms of whether manufacturers will supply the marketplace or not. That is a problem we have with Brexit in general.