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To ask the Secretary of State for Health and Social Care, how many (a) invitro diagnostic and (b) other medical devices that (i) are UK approved body certified and (b) self-declared under the Medical Devices Regulations 2002 are registered with the Medicines and Healthcare products Regulatory Agency.
To ask the Secretary of State for Health and Social Care, how many (a) invitro diagnostic and (b) other medical devices that (i) are UK approved body certified and (b) self-declared under the Medical Devices Regulations 2002 are registered with the Medicines and Healthcare products Regulatory Agency.
The information requested has been verified by the Medicines and Healthcare products Regulatory Agency (MHRA) but has not been previously published. The following table shows the number of medical devices registered with the MHRA including United Kingdom approved body certified and self-declared under Medical Devices Regulations (MDR) 2002.
| In Vitro-Diagnostic Medical Devices | General Medical Devices | Active Implantable Medical Devices | Total |
UK approved body certified | 1 | 187 | 1 | 189 |
Self-declared MDR 2002 | 1 | 169 | 0 | 170 |
Total | 2 | 356 | 1 | 359 |
The in-vitro diagnostic medical devices referenced were declared under part IV of the UK Medical Devices Regulations (MDRs) 2002, the general medical devices referenced were declared under part II of the UK MDRs 2002 and the active implantable medical devices were declared under part III of the UK MDRs 2002.
To ask the Secretary of State for Health and Social Care, what steps he is taking to maintain the supply of medical devices in the UK in light of increased financial and regulatory pressures for manufacturers.
To ask the Secretary of State for Health and Social Care, what steps he is taking to maintain the supply of medical devices in the UK in light of increased financial and regulatory pressures for manufacturers.
The Government recognises challenges faced by suppliers relating to financial pressures and regulatory changes. The Department and NHS Supply Chain (NHSSC) have robust measures in place to monitor supply chains, working closely with suppliers within the bounds of contractual agreements to secure value for money for taxpayers and maintain access to devices and clinical consumables.
Similarly, the Government remains committed to providing sufficient time for industry to transition to any new regulatory requirements, following its response to the Medicines and Healthcare products Regulatory Agency’s future medical device regulations consultation in June 2022. The latter outlined changes supporting innovation in the United Kingdom’s life sciences and access to medical devices.
To ask the Secretary of State for Health and Social Care, if she will support the healthtech sector by prioritising the development of domestic assurance routes that will allow recognition of approvals in the (a) Medical Device Single Audit Programme (MDSAP), (b) ACCESS consortium and (c) other trusted jurisdictions.
To ask the Secretary of State for Health and Social Care, if she will support the healthtech sector by prioritising the development of domestic assurance routes that will allow recognition of approvals in the (a) Medical Device Single Audit Programme (MDSAP), (b) ACCESS consortium and (c) other trusted jurisdictions.
On 21 April 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) was made a full member of the International Medical Device Regulators Forum. The MHRA is currently an official observer of the Medical Device Single Audit Programme. In January 2021, the MHRA joined the Access Consortium and has appointed experts to the majority of working groups.