1-20 of 39 results for subject:"Medical equipment"
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I declare that I am president of the CO Research Trust and a member of the Delegated Powers and Regulatory Reform Committee. The Minister has already referred to our report. I am also one of those people who responds when there is a call for a doctor on a flight,...
I declare that I am president of the CO Research Trust and a member of the Delegated Powers and Regulatory Reform Committee. The Minister has already referred to our report. I am also one of those people who responds when there is a call for a doctor on a flight,...
My Lords, I am absolutely delighted to follow the noble Lord, Lord Holmes, who has really put his finger on summarising all these amendments incredibly well. As you go through, you can look at each one as an individual case. Amendment 12 is about vulnerable people and where they are...
My Lords, I am absolutely delighted to follow the noble Lord, Lord Holmes, who has really put his finger on summarising all these amendments incredibly well. As you go through, you can look at each one as an individual case. Amendment 12 is about vulnerable people and where they are...
I thank the Minister very much for her introduction to this tide-over regulation, which is as it has been portrayed to us. I should declare that my son is involved in medical technology, in cardiology; you could say that our family has a bit of skin in the game, although...
I thank the Minister very much for her introduction to this tide-over regulation, which is as it has been portrayed to us. I should declare that my son is involved in medical technology, in cardiology; you could say that our family has a bit of skin in the game, although...
My Lords, I am grateful to the Minister for highlighting that we are a leader across Europe with our services, but only 50% of the country is covered. Can she assure us that in all reviews of the NHS, consideration will be given to centrally commissioned, highly specialised services such as this, rather than relying on local commissioning, that the workforce plan will recognise that highly skilled nurses are needed to undertake this treatment, and that that needs to be factored in? The numbers are small but the skills are enormous.
My Lords, I am grateful to the Minister for highlighting that we are a leader across Europe with our services, but only 50% of the country is covered. Can she assure us that in all reviews of the NHS, consideration will be given to centrally commissioned, highly specialised services such as this, rather than relying on local commissioning, that the workforce plan will recognise that highly skilled nurses are needed to undertake this treatment, and that that needs to be factored in? The numbers are small but the skills are enormous.
What the noble Baroness says is very true and I certainly can give the assurances she seeks.
To ask His Majesty's Government what progress they have made with the proposed amendments to the Part IX of the Drug Tariff, including any impact assessments on the future provision of medical technologies in the UK; how these proposals meet the ambitions of the Life Sciences Vision; and what steps...
To ask His Majesty's Government what progress they have made with the proposed amendments to the Part IX of the Drug Tariff, including any impact assessments on the future provision of medical technologies in the UK; how these proposals meet the ambitions of the Life Sciences Vision; and what steps...
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.
It is notable that the medical devices road map from the...
My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.
It is notable that the medical devices road map from the...
May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can...
May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can...
To ask Her Majesty’s Government how many COVID-19 lateral flow tests are awaiting approval under the Medical Devices (Coronavirus Test Device Approvals (Amendment) Regulations 2021; how many have been approved; and how many that already hold Medicines and Healthcare products Regulatory Agency approval will fall if not re-approved by the extended deadline of 28 February.
To ask Her Majesty’s Government how many COVID-19 lateral flow tests are awaiting approval under the Medical Devices (Coronavirus Test Device Approvals (Amendment) Regulations 2021; how many have been approved; and how many that already hold Medicines and Healthcare products Regulatory Agency approval will fall if not re-approved by the extended deadline of 28 February.
As of 3 February 2022, 87 lateral flow devices were in the CTDA approval process, and none have been approved—
I am grateful for the Minister’s response despite the late hour of last night’s debate. I am concerned that the information I have is that there are still 200 tests waiting, 46 have been assessed and validated at Porton Down, and the process is not well-aligned with the MHRA processes. What is being done to bring those processes back in line? What is being done to bring forward applications from devices that provide a differential diagnosis between Covid and influenza? These are already being used in Europe, but I understand that none are available in the UK because they have been held up in the validation process.
I am grateful for the Minister’s response despite the late hour of last night’s debate. I am concerned that the information I have is that there are still 200 tests waiting, 46 have been assessed and validated at Porton Down, and the process is not well-aligned with the MHRA processes. What is being done to bring those processes back in line? What is being done to bring forward applications from devices that provide a differential diagnosis between Covid and influenza? These are already being used in Europe, but I understand that none are available in the UK because they have been held up in the validation process.
I should perhaps start with some background on this and why we have reached the situation we are in. Her Majesty’s Government began the large-scale procurement of Covid-19 test kits at the height of the pandemic. To ensure supplies for the universal testing offer, Porton Down assesses tests offered to Government. It found that three-quarters of those offered failed to meet their stated performance in their instructions for use. For most testing technology, the manufacturer needed only to do self-assessment to meet the CE marking rules, but clearly, when they were tested, they were not meeting those standards. We considered that the current standard was insufficient and did not keep bad tests off the market. That is why we had a public consultation in April that showed strong support for a more rigorous regime. In terms of avoiding a cliff edge, as it were, if they have not been validated, we are looking at solutions.
To ask Her Majesty's Government why the definition of a health institution as defined in the Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain, published in January, differs from that in the MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern...
To ask Her Majesty's Government why the definition of a health institution as defined in the Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain, published in January, differs from that in the MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern...
The Northern Ireland Protocol has resulted in the European Union Medical Device Regulation (MDR) (2017/745) and the EU In Vitro Diagnostic Regulation (IVDR) (2017/746) taking direct effect in Northern Ireland on 26 May 2020 and 26 May 2022 respectively. In its guidance on the application of EU MDR and EU IVDR in Northern Ireland, the Medicines and Healthcare products Regulatory Agency (MHRA) has included the definition of a ‘health institution’ as determined by the EU.
The UK Medical Devices Regulations 2002 (as amended) does not define ‘health institution’. As a result, the MHRA has provided its own interpretation, which was set out in MHRA guidance on in vitro diagnostic medical devices when it was first published in August 2013. The MHRA continues to rely on this interpretation of the definition for Great Britain and this has not been altered in subsequent updates. However, this issue will be considered during the review of medical devices regulation taking place later this year.
My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy...
My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy...
My Lords, it is a great pleasure to follow the noble Lord, Lord Hunt of Kings Heath, on this very important amendment. It is an example of how, with high moral standards, the Ministers involved have been listening. With others, I wish to sincerely thank the noble Lords, Lord Bethell...
My Lords, it is a great pleasure to follow the noble Lord, Lord Hunt of Kings Heath, on this very important amendment. It is an example of how, with high moral standards, the Ministers involved have been listening. With others, I wish to sincerely thank the noble Lords, Lord Bethell...
My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in...
My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in...
My Lords, it is an honour to follow so many powerful speeches supporting this ground-breaking amendment, particularly that of my noble friend Lady Cox just now. We are 72 years on from the UN Convention on the Prevention and Punishment of the Crime of Genocide, yet we still fail to...
My Lords, it is an honour to follow so many powerful speeches supporting this ground-breaking amendment, particularly that of my noble friend Lady Cox just now. We are 72 years on from the UN Convention on the Prevention and Punishment of the Crime of Genocide, yet we still fail to...
My Lords, I am sorry that technical difficulties meant that I could not come in just now. I support Amendment 6 in the name of the noble Lord, Lord Purvis of Tweed, who made the case for it comprehensively. In Committee, the involvement of the devolved Administrations in consultation over...
My Lords, I am sorry that technical difficulties meant that I could not come in just now. I support Amendment 6 in the name of the noble Lord, Lord Purvis of Tweed, who made the case for it comprehensively. In Committee, the involvement of the devolved Administrations in consultation over...
Moved by
Baroness Finlay of Llandaff
95: Clause 16, page 9, line 18, leave out “may” and insert “must”
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.
Moved by
Baroness Finlay of Llandaff
95: Clause 16, page 9, line 18, leave out “may” and insert “must”
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.
My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.
First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step...
My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.
First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step...
My Lords, I thank all noble Lords who not only spoke in support of the amendments in this group but expanded on them and provided additional information.
I understand the Minister saying that it is important to get this right and not rush, and that the consultation will inform the SIs....
My Lords, I thank all noble Lords who not only spoke in support of the amendments in this group but expanded on them and provided additional information.
I understand the Minister saying that it is important to get this right and not rush, and that the consultation will inform the SIs....
My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.
The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I...
My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.
The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I...
Moved by
Baroness Finlay of Llandaff
91A: After Clause 13, insert the following new Clause—
“Innovative Medical Devices Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—
“(9A) The Secretary of State must make a scheme to promote the availability of innovative medical devices for human use within the...
Moved by
Baroness Finlay of Llandaff
91A: After Clause 13, insert the following new Clause—
“Innovative Medical Devices Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—
“(9A) The Secretary of State must make a scheme to promote the availability of innovative medical devices for human use within the...