Draft  Regulations  laid before  Parliament  under  section  47(3)  and (6)(a) of the Medicines  and 
Medical  Devices  Act 2021,  for approval  by resolution  of each  House  of Parliament.  
D R A F T  S T A T U T O R Y  I N S T R U M E N T S  
2021  No. 
MEDICAL  DEVICES  
The Medic al Devices  (Coronav irus Test Device  Authorisations)  
(Amendment)  Regulations  2021  
Made  - - - - *****  
Coming  into force  - - in accordance  with regulation  1 
The Secretary  of State,  makes  these  Regulations  in exercise  of the powers  conferred  by sections  
15(1) , 16(1)(a) , (b), (c) and (h), 17(1)(a) , 18 and 43 of the Medicines  and Medical  Devices  Act 
2021 (a) and after having  considered  the matters  set out in section  15(2)  to (4) of that Act. 
In accordance  with section  47(3)  and (6)(a) of that Act, a draft  of this instrument  has been  laid 
before  and approved  by a resolution  of each House  of Parliament.  
Citation , commencement , extent  and application  
1.—(1) These  Regulations  may be cited  as the Medical  Devices  (Coronavirus  Test Device  
Authorisations)  (Amendment)  Regula tions  2021 . 
(2) These  Regulations,  apart  from  regulation  8— 
(a) come  into force  on the day after the day on which  they are made , and 
(b) extend  to England  and Wales,  Scotland  and Northern  Ireland . 
(3) Regulation  8— 
(a) comes  into force  on 1st January  2022 ; 
(b) extends  to England  and Wales ; and 
(c) applies  in relation  to England ; 
Amendment  of the Medical  Devices  Regulations  2002  
2. The Medical  Devices  Regulations  2002( b) are amended  as follows.  
3. In regulation  2(c) after the definition  of “clinical  data”,  insert — 
 
(a) 2021 c.3.  
(b) S.I.2002/618. The Regulations have been amended on a number of occasions, most recently by the Medical Devices 
(Amendment etc .) (EU Exit) Regulation 2020 (S .I. 2020/1478).  
(c) Regulation 2 has been amended on a number of occasions, most recently by S .I. 2020/1478.  The definition of “clinical data” 
was inserted by S.I. 2008/2936.   2 ““coronavirus  test device ” means  an in vitro  diagnostic  medical  device  for the detection  
of the presence  of a viral antigen  or viral ribonucleic  acid (RNA)  specific  to sever e 
acute  respiratory  syndrome  coronavirus  2 (SARS -CoV -2);”. 
4. After  regulation  34, insert — 
“Authorisation  requirement  for coronavirus  test device s 
34A. —(1) Subject  to regulations  34B, 34C and 39A, no person  other  than the Secretary  
of State  may place  on the market  or put into servi ce a coronavirus  test device , unless  the 
Secretary  of State  has authorised  it in accordance  with regulation  38B(5), and the 
authorisation  remains  valid  in accordance  with regulation  38B(6) . 
(2) Subject  to regulations  34B, 34C and 39A, no person  other  than the Secretary  of State  
may supply  a coronavirus  test device — 
(a) if that supply  is also a placing  on the market  or putting  into service  of that device ; 
or 
(b) in circumstances  where  that device  has been  placed  on the market  or put into 
service,  
unless  the Secretary  of State  has authorised  it in accordance  with regulation  38B(5) and the 
authorisation  remains  valid  in accordance  with regulation  38B(6) . 
(3) The requirements  in paragraphs  (1) and (2) are without  prejudice  to the other  
requirements  of this Part. 
Public  sector  use of coronavirus  test devices  
34B.  —(1) Regulation  34A(1)  does not apply  in relation  to a coronavirus  test device  that 
is placed  on the market  or put into service  only for use by— 
(a) the Secretary  of State;  
(b) a devolved  public  health  body; or 
(c) a relevant  hospital  supplied  pursuant  to an existing  contract.  
(2) Regulation  34A(2) does not apply  in relation  to a coronavirus  test device  that is 
supplied  to— 
(a) the Secretary  of State ; 
(b) a devolved  public  health  body ; or 
(c) to a relevant  hospital  pursuant  to an existing  contract.  
(3) In this regulation — 
“a devolved  public  health  body”  is— 
(a) in Wales,  Welsh  Ministers  or Public  Health  Wales  National  Health  Service  Trust (a); 
(b) in Scotland,  Scottish  Ministers ; 
(c) in Northern  Ireland,  the Department  of Health  in Northern  Ireland . 
“an existing  contract”  is a contract  entered  into before  the entry  into force  of these  
Regulations ; 
“a relevant  hospital”  is— 
(a) in England,  a health  service  hospital  as defined  by section  275 of the National  
Health Service  Act 2006 (b); 
 
(a) Public Health Wales National Health Service Trust is an NHS Trust (see section 18 of the National Health Service (Wales) 
Act 2006)  established under the Public Health Wales National Health Service Trust (Establishment) Order 2009/2058 
(W.177).  
(b) 2006 c.41.  The definition of “health service hospital” in section 275 was amended by paragraph 138(2)(b) of Schedule 4 to 
the Health and S ocial Care Act 2012 (c. 7) and by S.I. 2013/160.   3 (b) in Wales,  a health  service  hospital  as defined  by section  206 of the National  Health  
Service  (Wales)  Act 2006 (a); 
(c) in Scotland,  a health  service  hospital  as defined  by section  108 of the National  
Health  Service  (Scotland)  Act 1978 (b); 
(d) in Northern  Ireland,  a hospital  as defined  by Article  2(2) of the Health  and 
Personal  Social  Services  (Northern  Ireland)  Order  1972( c). 
Transitional  provisions  for coronavirus  test devices  
34C.—(1) The requirements  in regulation  34A do not apply in respect  of any period  
before  1st September  2021.  
(2) A person  may place  on the market , put into service  or supply  a coronavirus  test device  
from  1st September  2021  until the end of 30th September  2021  if— 
(a) that person  has made  an application  to the Secretary  of State  in respect  of that 
device  before  1st October  2021,  in accordance  with regulation  38A; or 
(b) that person  is not the manufacturer  of the device . 
(3) A person  may place  on the market , put into service  or supply  a coronavirus  test devic e 
from  1st October  2021  until the end of 31st December  2021  if the Secretary  of State  has 
approved  it in accordance  with regulation  38A(5) .”. 
5. After  regulation  38, insert — 
“Applications  for preliminar y approval  of coronavirus  test device s 
38A. —(1) A person  may make  an application  to the Secretary  of State  under  this 
regulation  for approval  of a coronavirus  test device  for the purpose  of regulation  34C(2)  or 
38B(1)  (or both) . 
(2) An application  must  include such information  as the Secretary  of State  may require  
for the purposes  of exercising  their functions  under — 
(a) paragraph  (5); and 
(b) regulation  38D.  
(3) An application  must  be made  through  the gov.uk  website.  
(4) The Secretary  of State  may treat an application  made  before  the entry  in force  of this 
regulation  as an application  made  under  this regulation,  if it meets  the requirements  of 
paragraph  (2). 
(5) The Secretary  of State  must  approve  a coronavirus  test device  if the Secretary  of State  
is satisfied on the basis  of the information  contained  in the application  that the coronavirus  
test device  meets  the requirements  of regulation  38C.  
Applications  for authorisation  of coronavirus  test devices  
38B. —(1) A person  may make  an application  to the Secreta ry of State  for authorisation  of 
a coronavirus  test device , if the Secretary  of State  has approved  that device  in accordance  
with regulation  38A( 5). 
(2) An application  must  include  such information  as the Secretary  of State  may require  
for the purposes  of exercising  their functions  under — 
(a) paragraph  (5); and 
(b) regulation  38D.  
 
(a) 2006 c.42.  
(b) 1978 c.29.  
(c) 1971 No.1265 (N.I. 14).   4 (3) An application  must  be made  through  the gov.uk  website.  
(4) A person  making  an application  must  deliver  to the address  specified  by the Secretary  
of State — 
(a) such assays  of the coronavirus  test device , and 
(b) such equipment  and ancillary  materials  as it requires  to perform  its function , 
as the Secretary  of State  may require  for the purpose  of exercising  the functions  under  
paragraph  (5). 
(5) The Secretary  of State  must  autho rise a coronavirus  test device  if the Secretary  of 
State  is still satisfied  on the basis  of— 
(a) the information  contained  in the application,  and 
(b) such assessments  of the assays  as the Secretary  of State  considered  necessary,  
that the coronavirus  test device  meets  the requirements  of regulation  38C. 
(6) An authorisation  granted  under  paragraph  (5) is valid  for a period  of 5 years,  
beginning  with the day on which  it is granted.  
(7) Nothing  in this regulation  or regulation  38A shall be taken  to prevent — 
(a) the Secretary  of State ; 
(b) a weights  and measures  authority  in Great  Britain ; or 
(c) a district  council  in Northern  Ireland , 
from  exercising  a duty under  regulation  61 to enforce  these  Regulations.  
Performance  requirements  for coronavirus  test device s 
38C. —(1) The requirements  that a coronavirus  test device  must  meet  for the purposes  of 
regulations  38A(5) and 38B(5) are set out in paragraphs  (2) to (6). 
(2) A coronavirus  test device  must  be able to be put into service  in accordance  with this 
Part. 
(3) A coronavirus  test device  that is an antigen  test must  have — 
(a) a level  of sensitivity , using  a 95% two-sided  confidence  interval , that is entirely  
above  60%; 
(b) a level  of specificity , using  a 95% two-sided  confidence  interval , that is entirely  
above  93%. 
(4) A coronavirus  test device  that is a direct  molecular  test must  have — 
(a) a level  of sensitivity , using  a 95% two-sided  confidence  interval , that is entirely  
above  70%; 
(b) a level  of specificity , using  a 95% two-sided  confidence  interval , that is entirely 
above  93%. 
(5) A coronavirus  test device  that is an extracted  molecular  test must  have — 
(a) a level  of sensitivity , using  a 95% two-sided  confidence  interval , that is entirely  
above  93%; 
(b) a level  of specificity , using  a 95% two-sided  confidence  interval , that is entirely  
above  97%. 
(6) Where  a coronavirus  test device  is also intended  to detect  the presence  of anything  
other  than a viral antigen  or viral ribonucleic  acid (RNA)  specific  to severe  acute  
respiratory  syndrome  coronavirus  2 (SARS -CoV -2), the requirements  in paragraphs  (2) to 
(5) apply  only in relation  to its performance  in detecting  the presence  of that viral antigen  or 
viral ribonucleic  acid (RNA).  
(7) In this regulation  and in regulation  38D—  5 “antigen  test” means  an in vitro  diagnostic  medical  device  for the detection  of the 
presence  of a viral antigen  specific  to severe  acute  respiratory  syndrome  coronavirus  2 
(SARS -CoV-2); 
“direct  molecular  test” means  an in vitro  diagnostic  medical  device  which — 
(a) is for the detection  of the presenc e of viral ribonucleic  acid (RNA)  specific  to severe  
acute  respiratory  syndrome  coronavirus  2 (SARS -CoV -2), and 
(b) does not use a preliminary  step of purification  and concentration ; 
“extracted  molecular  test” means  an in vitro diagnostic  medical  device  which— 
(a) is for the detection  of the presence  of viral ribonucleic  acid (RNA)  specific  to severe  
acute  respiratory  syndrome  coronavirus  2 (SARS -CoV -2), and 
(b) uses a preliminary  step of purification  and concentration;  
“sensitivity”,  in relation  to a coron avirus  test device , means  how often  the device  
correctly  generates  a positive  result;  
“specificity”,  in relation  to a coronavirus  test device , means  how often  the device  
correctly  generates  a negative  result . 
Register  of authorised  coronavirus  test device s 
38D. —(1) The Secretary  of State  must  establish  a register  of coronavirus  test device s 
which  the Secretary  of State  has approved  in accordance  with regulation  38A or authorised  
in accordance  with regulation  38B.  
(2) The Secretary  of State  may publish  some  or all parts  of the register  on the gov.uk  
website.  
(3) The register  must  contain  the following  information  in respect  of each coronavirus  test 
device — 
(a) the name  and address  of the registered  place  of business  of the person  who made  
the application  unde r regulation  38A or 38B,  as the case may be; 
(b) if that person  was not the manufacturer,  the name  and address  of the registered  
place  of business  of the manufacturer;  
(c) the country  in which  the manufacturer  is established;  
(d) the name  and address  of the registered  place  of business  of the UK responsible  
person  or the manufacturer’s  authorised  representative  having  a registered  place  of 
business  in Northern  Ireland , if there  is one in respect  of the device ; 
(e) the name  and description  of the coronavirus  test device ; 
(f) the date and version  number  of the instructions  for use included  in the application;  
(g) whether  the device  is an antigen  test, a direct  molecular  test, or an extracted  
molecular  test; 
(h) whether  the device  has been— 
 (i) approved  in accordance  with regulation  38A,  or 
 (ii) approved  in accordance  with regulation  38A and authorised  in accordance  
with regulation  38B;  
(i) the date on which  any such approval  or authorisation  was granted  and, in the case 
of an authorisation,  the date on which  it ceases  to be valid;  
(j) the levels  of sensitivity  and specificity  determined  by any assessments  of the 
assays  conducted  by the Secretary  of State  for the purpose  of regulation  38B(5) . 
(4) The register  may contain  such other  information  relating  to the device  and its intended  
use as the Secretary  of State  considers  appropriate. ”. 
6. After  regulation  39, insert —  6 “Exemptions  for coronavirus  test devices  
39A. —(1) Regulation  34A does not apply  where,  in circumstances  which  give rise to a 
need  to protect  the public  from  a risk of serious  harm  to health,  the Secretary  of State — 
(a) has decided  to permit , where  appropriate  for a specified  period,  the placing  on the 
market  or putting  into service  of a particula r coronavirus  test device  or coronavirus  
test device s of a particular  class  or description  that has not been  authorised  under  
regulation  38B(5) ; and 
(b) has not withdrawn  that permission . 
(2) The Secretary  of State  may make  their permission  under  paragraph  (1) subject  to 
conditions,  if those  conditions  are set out in a protocol  published  by the Secretary  of State.  
(3) If the Secretary  of State  publishes  a protocol  for the purpose  of paragraph  (2), the 
protocol  must  specify  the period  of time for which  it has effect . 
(4) The Secretary  of State  may withdraw  or amend  a protocol  that the Secretary  of State  
has published .”. 
7. After  regulation  56 (fees  payable  in relation  to clinical  investigation  bodies)  insert — 
“Fees in connection  with  authorisation  of coronavirus  test device s 
56A. —(1) A person  who makes  an application  to the Secretary  of State  under  regulation  
38A(1)  must  pay to the Secretary  of State  a fee of— 
(a) £14,000; or 
(b) if the person  is a small  or medium -sized  enterprise , £6,200 . 
(2) Where  the Secretary  of State,  in accordance  with regulation  38A( 4), treats  an 
application  made  before  the entry  into force  of regulation  38A as an application  made  under  
that regulation,  a payment  made  in respect  of that application  before  the entry  into force  of 
this regulation  must  be treated  as a payment  made  for the purpose  of paragraph  (1). 
(3) A person  who makes  an application  to the Secretary  of State  under  regulation  38B(1)  
must  pay to the Secretary  of State  a fee of— 
(a) £75,000 ; or 
(b) if the person  is a small  or medium -sized  enterprise , £28,800 . 
(4) In this regulation — 
(a) a person  is a small  or medium -sized  enterprise  if it and persons  associated  with it 
employ  no more  than 50 individuals  in total; and 
(b) “persons  associated  with it” has the same  meaning  as in section  882 of the 
Corporation  Tax Act 2010( a).”. 
Amendment  of the Health  Protection  (Coronavirus,  Testing  Requirements  and Standards)  
(England)  Regulations  2020  
8. In regulati on 4 of the Health  Protection  (Coronavirus,  Testing  Requirements  and Standards)  
(England)  Regulations  2020( b)— 
(a) for paragraph  (1), substitute — 
“(1) Any device  used for the purposes  of an applicable  test must  be able to be put into 
service  in accordance  with Part 4 of the Medical  Devices  Regulations  2002,  other  than by 
virtue  of an authorisation  or permission  under  regulation  39(2)  or 39A(1)  of those  
Regulations. ”; 
 
(a) 2010 c.4.  
(b) S.I.. 2020/1549.    7 (b) omit paragraph  (2); 
(c) in paragraph  (3), omit the definitions  of “specificity”  and “sensitivity”.  
Review  
9.—(1) The Secretary  of State  must  carry  out a review  of the provisions  made  by these  
Regulations  and publish  a report  setting  out the conclusions  of the review.  
(2) The report  must be published  on or before  31st December  2022.  
(3) The report  must,  in particular — 
(a) set out the objectives  intended  to be achieved  by the provision  made  by these  
Regulations;  
(b) assess  the extent  to which  those  objectives  are achieved;  
(c) assess  whether  those  objec tives remain  appropriate;  and 
(d) if those  objectives  remain  appropriate,  assess  the extent  to which  they could  be achieved  
in another  way which  involves  less onerous  provision.  
 
 
 Name  
Address  Parliamentary  Under  Secretary  of State  
Date Department  
 
EXPLANATOR Y NOTE  
(This  note is not part of the Regulations)  
These  Regulations  amend  the Medical  Devices  Regulations  2002  (S.I. 2002/618) , to require  that 
coronavirus  test devices  must  be authorised  by the Secretary  of State,  before  they are placed  on 
market  or put into service.  They  specify  application  procedure s for authorisation  and preliminary  
approval,  and the performance  requirements  that such devices  must  meet  for the purposes  of those 
procedure s. They also provide  for exemptions  from  that procedure  for public  service  use and 
provide  that the Secretary  of State  must establish  a register  of authorised  coronavirus  test devices.  
There  are transitional  provisions  in respect  of devices  placed  on the market  before  31st December  
2021 . Consequential  amendments  are made  to the Health  Protection  (Coronavirus,  Testing  
Requirements  and Standards)  (England)  Regulations  2020 . Regulation  9 requires  the Regulations  
to be reviewed,  and a report  published  on or before  31st December  2022.  
An assessment  of the impact  of this instrum ent has been  made.  A copy  of this impact  assessment  
is annexed  to the Explanatory  Memorandum  which  is available  alongside  this instrument  on the 
legislation.gov.uk  website.  Copies  may also be obtained  from  the Department  of Health  and Social  
Care,  39 Victo ria Street,  London  SW1H  0EU.