1-12 of 12 results for subject:"Medical equipment"
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My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can...
My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can...
My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.
I am very happy to support...
My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.
I am very happy to support...
My Lords, I am speaking on the telephone, as something went wrong with my iPad.
I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number...
My Lords, I am speaking on the telephone, as something went wrong with my iPad.
I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number...
My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.
It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE...
My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.
It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE...
My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have...
My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have...
My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation...
My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation...
My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for tabling this very important amendment. For a long time, I have been interested in the growing resistance to antibiotics. The residue of many of them, used for both humans and animals, pass into the environment by different...
My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for tabling this very important amendment. For a long time, I have been interested in the growing resistance to antibiotics. The residue of many of them, used for both humans and animals, pass into the environment by different...
My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.
I spoke at Second Reading of the need to provide an attractive...
My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.
I spoke at Second Reading of the need to provide an attractive...
My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of...
My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of...
My Lords, when the noble Lord, Lord O’Shaughnessy, gave up his position at the Department of Health, many people were dismayed, as he was doing an excellent job. I am so pleased that he is still involved with the health service, and today is an example, as he has brought...
My Lords, when the noble Lord, Lord O’Shaughnessy, gave up his position at the Department of Health, many people were dismayed, as he was doing an excellent job. I am so pleased that he is still involved with the health service, and today is an example, as he has brought...
My Lords, I thank the Minister for the support he has given to the epileptic women who have taken valproate, resulting in them having children with autism. The marking and the advice were not there for them. Does the Minister realise that many people are concerned about the European Medicines...
My Lords, I thank the Minister for the support he has given to the epileptic women who have taken valproate, resulting in them having children with autism. The marking and the advice were not there for them. Does the Minister realise that many people are concerned about the European Medicines...
To ask Her Majesty’s Government whether they have plans to regulate the use of in vitro diagnostics outside a hospital setting.[HL3845]
To ask Her Majesty’s Government whether they have plans to regulate the use of in vitro diagnostics outside a hospital setting.[HL3845]
There are no plans to regulate in vitro diagnostics or pathology tests beyond the restrictions provided in directive 98/79/EC on in vitro diagnostic medical devices (IVDs). This directive places requirements on the standards that need to be met by IVDs before they are placed on the European Union market. It includes an exemption from the provisions of the legislation for IVDs manufactured and used in-house by health institutions.
There are no specific additional requirements placed on all IVDs used outside a hospital setting, although IVDs intended for self-testing must fulfil certain additional requirements of the directive. In addition, the Medicines and Healthcare products Regulatory Agency has recently produced fact sheets aimed at the public to provide guidance and advice on the use of self-test IVDs. These can be found at: www.mhra.gov.uk/Safety information/Generalsafetyinformationandadvice/Adviceandinformationforconsumers/Buyingmedical devices/Selftestkits/index.htm.
Directive 98/79/EC is currently the subject of a revision by the European Commission. Revised provisions were published in September 2012, for agreement through the ordinary legislative procedure. This process is not yet completed. The revised legislation maintains an exemption for health institutions manufacturing and using IVDs in-house; but includes additional requirements for those health institutions to meet certain standards and an exclusion from the exemption for the highest risk devices. It will also place additional requirements that will need to be met by IVDs intended for self-testing above and beyond those in the current directive. The Government are content to impose such additional requirements, while continuing the current exemption for products contained in the current directive.