Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord McColl of Dulwich Excerpts

Monday 12th July 2021 Grand Committee

[Lord McColl of Dulwich (Con) [V]]

My Lords, as there are more than half a million of these devices on the market, it is understandable that effective regulation should be in place and workable. It is also clear that most of us will need one of these devices at some time in our life. It is to be hoped that these regulations will give patients more information and choice, and that they will benefit from more up-to-date therapies. I ask the Minister this: what will be the effective way of seeking expert opinions on the wisdom of a proposed new operation that does not necessarily involve a medical device? It would be helpful to have a second opinion on whether it is likely to be feasible and safe.

As there are often notoriously long delays in obtaining answers from official bodies, and we are talking about regulations now, has any thought been given to placing a regulation to require answers within a certain time?

There has been discussion about a robust financial compensation mechanism to ensure that patients are dealt with fairly and justly for the damage caused by defective devices and by their inappropriate use in certain parts of the body. For instance, the mesh which caused so much damage in operations for incontinence is used widely and safely in hernia operations. Could the Minister tell the Committee who will operate these compensation mechanisms? Who will decide whether compensation is justified and how much to award?