Medical Equipment: Registration
(asked on 22nd May 2023) - View Source
Question to the Department of Health and Social Care:
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.