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Written question asked by Virendra Sharma (Labour) on Monday, 22 May 2023, in the House of Commons. It was due for an answer on Thursday, 25 May 2023 (named day). It was answered by Will Quince (Conservative) on Thursday, 25 May 2023 on behalf of the Department of Health and Social Care.

Medical Equipment: Registration

Question

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.

Answer

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.

Secondary information

Type
Written question
Reference
186029
Session
2022-23
Subjects
Medical equipment Registration Regulation Medicines and Healthcare products Regulatory Agency
Legislation
Medical Devices Regulations 2002
Contains statistics
Yes
Link
View this Written question on www.parliament.uk