Medical Devices Regulations 2002: protocols
Updated 24 June 2022
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PROTOCOL in accordance with regulation 39A(2) and (3) of the Medical Devices Regulations 2002
The Secretary of State, in exercise of the power under regulation 39A of the Medical Devices Regulations 2002 and, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, has decided to permit the placing on the market and putting into service of the coronavirus test devices that meet the conditions of this protocol.
1. This protocol applies to devices listed in the annexe to this protocol. An application has been made in respect of each of the listed devices under regulation 38A of the Medical Devices Regulations 2002, and that application has not yet been determined or withdrawn.
2. This protocol applies in the whole of the UK.
3. After the expiry of the relevant period in paragraph 4 and notwithstanding its continued listing in the annexe, this protocol ceases to apply to a coronavirus test device if the application that was made under regulation 38A of the Medical Devices Regulations 2002 is withdrawn or not approved.
4.The relevant period is: a. in the case of an application that is withdrawn, 10 working days following the day on which DHSC was notified of the withdrawal; or b. in the case where an application is not approved, 10 working days following the day on which the manufacturer was notified that the test had not been approved.
In this paragraph ‘notified’ includes notification by means of an email.
5. This protocol is valid from 1 March 2022 until 31 May 2022 for those on list A and until 31 August 2022 for those on list B, unless amended or replaced by a subsequent protocol before those respective dates.
6. Version number: 1
7. You can get in contact by email: validation@dhsc.gov.uk
8. You can also write to us at:
Department of Health and Social Care
39 Victoria Street
London SW1H 0EU
9. Change history: Version 1
Secretary of State for Health and Social Care
Date: 24 February 2022
Protocol annexe: list of exempted COVID-19 in-vitro diagnostic devices
Self-test protocol – 6 months
| Manufacturer | Device name | IFU number | CE Mark |
|---|---|---|---|
| Acon Biotech(Hangzhou) Co., Ltd | Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing); Flowflex SARS-CoV-2 Antigen Rapid Test | 1151327403 Effective Date: 2021-06-29 | CE Certificate Number No. V9 042074 0032 Rev. 00 |
| SD Biosensor | SARS COV 2 Antigen Self Test Nasal | 09441476001, V 2, 2021-06 | CE cert number No. V1 075369 0058 Rev. 01 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hughes SARS-CoV-2 Antigen Rapid Test(Self-Testing) | 1151297001 Effective Date: 2021-06-18 | CE Certificate Number No. V9 042074 0032 Rev. 00 |
| Guangzhou Wondfo Biotech Co., Ltd. | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | P/N W634P0024 W634P0025, W634P0026, W634P0027, W634P0028 W634P0029) Rev. A2 Rel.:2021/05/28 | CE Cert No: V9 0580080037 Rev.00 |
| Healgen Scientific Limited Liability Company | Rapid COVID-19 Antigen Self-Test | : P/N GCCOV-502a-H1 GCCOV-502a-H2 GCCOV-502a-H3 GCCOV-502a-H5 GCCOV-502a-H7 GCCOV-502a-H10 GCCOV-502a-H15 GCCOV-502a-H20 Revision date: 2021-12-28 |
CE Cert No No. V9 092378 0008 Rev. 00 |
| Zhejiang Orient Gene Biotech Co.Ltd | Rapid COVID-19 (Antigen) Self-Test | Revision 11-11-2021 | CE Certificate Number: V9 092305 0003 Rev. 00 |
| Hangzhou Laihe Biotech Co.; Ltd. | Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) for self testing | (Cat No.: 3030) V2.0/EN Effective Date: May 15,2021 | CE Number- HL206 9313-1 |
| SD Biosensor, Inc. | SARS-CoV-2 Antigen Self Test Nasal | L23SCR13JML02RI | CE Cert Number No. V1 075369 0058 Rev. 01 |
| Beijing Beier Bioengineering Co Ltd | COVID-19 Antigen Rapid Test Kit | IFU revision date: 12.01.2021 Ref: COVID 19AG20-1.1 | CE Cert Number 1434-IVDD-472/2021 |
| Healgen Scientific Limited Liability Company | CLINITEST Rapid COVID-19 Antigen Self Test Two IFUs containing product numbers but no IFU number or version number 1155633 (GCCOV-502-H1) |
11556327 (GCCOV-502-H5) | CE Cert No. V9 092378 0008 Rev. 01 |