Proposal for a COUNCIL RECOMMENDATION on a common framework for the use, validation and mutual recognition of COVID-19 rapid antigen tests in the EU
Date: 2020-12-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, coronavirus disease, disease prevention, disease surveillance, epidemic, health care system, medical device, medical diagnosis, mutual recognition principle, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 18.12.2020  COM(2020) 849 final 2020/0377 (NLE)  Proposal for a COUNCIL RECOMMENDATION on a common framework for the use, validation and mutual recognition of COVID-19 rapid antigen tests in the EU  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

As  outlined  in  the  Commission  Communication  on  short-term  EU  health  preparedness  for 
COVID-19  outbreaks1,  adopted  on  15  July  2020,  robust  testing  strategies  and  sufficient 
testing  capacities  are  essential  aspects  of  preparedness  and  response  to  COVID-19.  They 
allow  for  early  detection  of  potentially  infectious  individuals  with  a  view  to  swiftly  isolate 
them from  the  rest  of the population  and therefore avoid infections  and transmission within 
communities. Moreover, they are a prerequisite to adequate contact tracing to limit the spread 
through prompt and targeted isolation or quarantine measures. 

Effective  testing  also  contributes  to  fostering  free  movement  of  persons  and  to  the  smooth 
functioning  of  the  internal  market  in  the  context  of  the  COVID-19  pandemic.  Since  the 
beginning of the pandemic, the field of diagnostic COVID-19 tests has been rapidly evolving, 
further  underpinning  the  central  role  it  plays  in  outbreak  control.  The  appropriate  use  of 
COVID-19  tests,  which  includes  putting  in  place  sufficient  testing  volumes  for  target 
populations,  providing  the  opportunity  for  repeated  testing  and  ensuring  a  rapid  turnaround 
time between the test request and result, are elements that play a significant role in reducing 
the spread of SARS-CoV-2.  

For an effective management of the different stages of the pandemic, it is vital to understand 
what  information  different  tests  can  deliver,  as  elaborated  in  the  guidelines  adopted  on  15 
April by the Commission2. Currently, the most reliable methodology for testing of cases and 
contact tracing is the RT-PCR (reverse transcription polymerase chain reaction) assay, which 
is a nucleic acid amplification test (NAAT). RT-PCR assays were among the earliest available 
tests  when the pandemic reached the European  continent.  While RT-PCR testing  rates have 
increased  across  the  EU,  resulting  in  the  identification  of  more  COVID-19  positive  cases, 
laboratories  are  struggling  to  ensure  that  sufficient  resources  and  capacities  are  in  place  to 
keep  up  with  demands.  The  constant  high  demand  has  resulted  in  relative  shortages  of  RT-
PCR  testing  materials  and  longer  testing  turnaround  times,  thereby  limiting  the  effective 
implementation of mitigation measures as well as swift contact tracing. 

In  this  context,  Member  States  are  increasingly  turning  to  the  possibility  of  using  rapid  or 
point of care tests (e.g. antigen tests) in specific settings3. This new generation of faster and 
cheaper  COVID-19  tests,  allowing  for  a  test  result  in  often  less  than  30  minutes,  is 
increasingly  entering 
the  Commission  adopted  a 
Recommendation setting out guidance for countries regarding key elements to be considered 
for  their  COVID-19  testing  strategies,  including  the  use  of  rapid  antigen  tests.  On  18 
November, the Commission adopted a Recommendation on the use of rapid antigen tests for 
the diagnosis of COVID-195, published together with technical guidelines on the use of rapid 

the  market.  On  28  October4, 

1 

2 
3

4 
5 

EN 

https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A52020DC0318&qid=1603899755406 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020XC0415%2804%29 

https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/common_testingappro

ach_covid-19_en.pdf 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020H1595&qid=1607002103669 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1743 

1 

  EN 

                                                 
 
antigen  tests,  developed  by  the  European  Centre  for  Disease  Prevention  and  Control 
(ECDC)6. 

On 2 December,  Member States called for the adoption of a common approach for the use of 
rapid  antigen tests  (complementary to  RT-PCR tests) and the intensification of coordination 
efforts as regards the facilitation of mutual recognition of test results was broadly recognised 
as a high priority in almost all interventions7.  

On  4  December,  the  Presidency  progress  report  on  EU  coordination  in  response  to  the 
COVID-19 pandemic8 recommended that: “[…] Member States should continue to exchange 
regularly on national testing strategies, including on the use of rapid antigen tests. Agreement 
on settings where these tests can be performed as well as on their validations will facilitate 
mutual recognition of test results”. 
During  the  meeting  of  the  European  Council  on  10  December9,  EU  Heads  of  State  or 
Governments adopted conclusions on COVID-19, in which they called on the Commission to 
present a proposal for a Council Recommendation on a common framework for rapid antigen 
tests and for the mutual recognition of test results. 

• 

Consistency with existing policy provisions in the policy area 

This recommendation serves to implement the existing provisions in the policy area, namely 
recommendations to EU Member States concerning the use of diagnostic COVID-19 tests and 
the implementation of COVID-19 testing strategies in the EU. 

• 

Consistency with other Union policies 

This  recommendation  is  in  line  with  other  Union  policies,  including  those  regarding  public 
health and medical devices. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  Treaty  on  the  Functioning  of  the  European  Union  (TFEU),  and  in  particular  Article 
168(6), thereof. 

• 

Subsidiarity (for non-exclusive competence)  

Article 168(6) TFEU enables the Council to adopt, based on a proposal from the Commission, 
recommendations for the purposes set out in Article 168 TFEU. 

A consistent  and  common approach regarding the use, validation and mutual recognition  of 
COVID-19  rapid  antigen  tests  contributes  to  the  good  functioning  of  the  single  market  and 
avoids duplication of efforts across the EU. Moreover, if follows a request of Member States 
to have a harmonised and joint approach. This would also facilitate sharing of experiences and 
allow for more efficient and better targeted restrictive measures. 

• 

Proportionality 

The present proposal takes account of the evolving epidemiological situation and all available 
relevant  evidence.  The  authorities  of  the  Member  States  and  the  Schengen  Associated 

6 

7 
8 
9 

https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-
uk 
COREPER II, 2 December 2020, Meeting n°290522.  
https://data.consilium.europa.eu/doc/document/ST-13551-2020-REV-1/en/pdf  
https://www.consilium.europa.eu/en/meetings/european-council/2020/12/10-11/  

EN 

2 

  EN 

                                                 
Countries remain responsible for implementing the proposed Council Recommendation. The 
proposal  is  suitable  for  achieving  the  intended  objective  and  does  not  go  beyond  what  is 
necessary and proportionate. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

3. 

• 

N/A 

• 

Stakeholder consultations and impact assessment 

This proposal takes into account discussions with Member States, particularly those that took 
place  in  the  context  of  the  Health  Security  Committee  and  the  Integrated  Political  Crisis 
Response  (IPCR),  since  the  start  of  the  COVID-19  pandemic.  While  no  separate  impact 
assessment  was  undertaken,  the  proposal  takes  into  account  the  evolving  epidemiological 
situation and is based on all available relevant evidence and scientific advice.  

4. 

BUDGETARY IMPLICATIONS 

None 

EN 

3 

  EN 

2020/0377 (NLE) 

Proposal for a 

COUNCIL RECOMMENDATION 

on a common framework for the use, validation and mutual recognition of COVID-19 
rapid antigen tests in the EU 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(6) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

In  line  with  Article  168(1)  and  (2),  a  high  level  of  human  health  protection  shall  be 
ensured  in  the  definition  and  implementation  of  all  Union  policies  and  activities. 
Union action shall cover, amongst other, monitoring, early warning of and combating 
serious  cross-border  threats  to  health,  and  shall  encourage  cooperation  between  the 
Member States in this area and, if necessary, lend support to their action.  
In line with Article 168(7) of the Treaty on the Functioning of the European Union10, 
the  definition  of  health  policy  as  well  as  the  organisation  and  delivery  of  health 
measures  remain  a  national  competence.  EU  Member  States  are  thus  responsible  for 
deciding  on  the  development  and  implementation  of  COVID-19  testing  strategies, 
including  the  use  of  rapid  antigen  tests,  taking  into  consideration  countries’ 
epidemiological and social situations as well as the target population for testing.  

On  15  April,  the  Commission  adopted  Guidelines  on  COVID-19  in  vitro  diagnostic 
tests  and  their  performance11,  providing  considerations  on  test  performance  and 
recommending  that  COVID-19  tests  be  validated  prior  to  introducing  them  into  the 
clinical routine.  

On  15  July,  the  Commission  adopted  a  Communication  on  short-term  EU  health 
preparedness  for  COVID-19  outbreaks12,  which,  among  other  measures  to  reinforce 
preparedness and coordinated response capacities, identified testing as one of the main 
action  areas  to  be  addressed  by  Member  States,  and  which  set  out  specific  key 
measures to be taken in the next months.  

On  28  October,  the  Commission  adopted  a  Recommendation  on  COVID-19  testing 
strategies,  including  the  use  of  rapid  antigen  tests13.  The  Recommendation  set  out 
guidance  for  countries  regarding  key  elements  to  be  considered  for  their  COVID-19 
testing  strategies,  and  considerations  for  the  use  of  rapid  antigen  tests  were  also  put 
forward.  

10 
11 
12 
13 

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020XC0415%2804%29  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0318  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1595  

EN 

4 

  EN 

                                                 
(6) 

(7) 

(8) 

(9) 

On  18  November,  the  Commission  adopted  a  Recommendation  on  the  use  of  rapid 
antigen  tests  for  the  diagnosis  of  SARS-CoV-2  infection14,  further  specifying  the 
criteria  to  be  used  for  the  selection  of  rapid  antigen  tests,  the  settings  during  which 
rapid  antigen  tests  are  appropriate  to  be  used,  test  operators,  validation  and  mutual 
recognition  of  rapid  antigen  tests  and  their  results.  While  cheaper  and  faster,  rapid 
antigen tests have generally a lower test sensitivity than RT-PCR. 

The  currently  applicable  regulatory  framework  for  placing  rapid  antigen  tests  on  the 
market  is  Directive  98/79/EC15.  According  to  the  Directive,  for  SARS-CoV-2  rapid 
antigen  tests,  the  manufacturer  must  draw  up  a  technical  file  which  explicitly  shows 
that the test  is safe and  performs  as  intended by the manufacturer, by demonstrating 
compliance with the requirements laid down in Annex I of the Directive.  

From  26  May  2022,  Directive  98/79/EC  will  be  replaced  by  Regulation  (EU) 
2017/746 on in vitro diagnostic medical devices16. Under the Regulation, rapid antigen 
tests will be subject to reinforced requirements on device performance and a thorough 
assessment by a notified body. This may reduce the additional effort required for the 
validation of these tests prior to their use as part of national strategies. 

Effective  testing  contributes  to  the  smooth  functioning  of  the  Internal  Market  as  it 
allows for targeted isolation or quarantine measures. Mutual recognition of test results 
for  SARS-CoV-2  infection  carried  out  in  other  Member  States  by  certified  health 
bodies, as provided for in point 18 of Council Recommendation (EU) 2020/147517, is 
essential in order to facilitate cross-border movement, cross-border contact tracing and 
treatment. 

(10)  Given  the  requirement  for  EU  candidate  countries  and  EU  potential  candidate 
countries  as  well  as  for  the  Deep  and  Comprehensive  Free  Trade  Areas  (DCFTA) 
countries to align to the EU acquis, and the participation of some of these countries in 
this  proposal  for  a  Council 
joint  procurement  for  relevant  products, 
EU 
Recommendation may also be of interest to these countries. 

HAS ADOPTED THIS RECOMMENDATION: 

Use of rapid antigen tests  

Member States should:  

1. 

2. 

Continue using rapid antigen tests as a way of further strengthening countries’ 
overall  testing  capacity,  particularly  because  testing  remains  a  key  pillar  in 
controlling  and  mitigating  the  ongoing  COVID-19  pandemic,  as  it  allows  for 
adequate  and  swift  contact  tracing  and  the  implementation  of  prompt  and 
targeted isolation and quarantine measures. 

Primarily consider the use of rapid antigen tests in case of limited  nucleic acid 
amplification  test  (NAAT)  capacities,  particularly  RT-PCR  assays,  or  where 
prolonged  testing  turnaround  times  results  in  no  clinical  utility,  which  would 
hinder  the  swift  identification  of  infected  cases  and  reduce  the  impact  of 
contact-tracing efforts.  

14 
15 
16 

17 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1743  
OJ L 331, 7.12.1998, p. 1–37.  
OJ L 117, 5.5.2017, p. 176. The Regulation provides for a transition period starting on the date of its 
entry into force (May 2017) during which the conformity of in vitro diagnostic medical devices can be 
assessed either under the Regulation or under Directive 98/79/EC. 
OJ L 337, 14.10.2020, p. 3. 

EN 

5 

  EN 

                                                 
3. 

4. 

5. 

6. 

Ensure that rapid antigen testing is conducted by trained healthcare personnel 
or  other  trained  operators  where  appropriate  and  in  line  with  national 
specifications, as well as in strict accordance with manufacturer’s instructions 
and subject to quality control.  

Invest in training and, if appropriate, certification of healthcare personnel and 
other  operators  to  carry  out  sampling  and  testing,  thereby  ensuring  adequate 
capacities as well as safeguarding the collection of good quality samples.  

Ensure that the results of rapid antigen testing are registered in the respective 
national data collection and reporting systems. 

Consider, in particular, the use of rapid antigen tests in the following situations 
and settings:  

(a)  COVID-19 diagnosis among symptomatic cases, regardless of the setting 
or  situation.  Rapid  antigen  tests  should  be  used  within  the  first  5  days 
following symptom onset, when viral load is highest. Patients admitted to 
hospitals  or  residents  admitted  to  social-care  settings  who  are  showing 
COVID-19  compatible  symptoms,  should  preferably  be  tested  upon 
admission. 

(b)  Contacts  of  confirmed  cases:  rapid  antigen  testing  of  asymptomatic 
contacts  should  be  done  as  soon  as  possible  and  within  the  first  7  days 
after contact, in line with applicable guidance.  

(c)  Outbreak  clusters,  for  early  detection  and  isolation  of  cases.  The 
screening of both symptomatic and asymptomatic cases in this context is 
relevant.  

(d)  Screening in high-risk areas and closed settings, such as hospitals, other 
healthcare  settings,  long-term  care  facilities  such  as  retirement  and 
nursing  homes  or  residential  settings  for  persons  with  disabilities, 
schools,  prisons,  detention  centres  or  other  reception  infrastructures  for 
asylum  seekers  and  migrants,  and  for  homeless  populations.  In  case  of 
repeated screening, this should be carried out every 2-4 days, and the first 
positive result identified by rapid antigen testing should be confirmed by 
RT-PCR. 

(e) 

In  epidemiological  situations  or  areas  where  the  proportion  of  test 
positivity  is  high  or  very  high  (e.g.  >  10%),  rapid  antigen  tests  can  be 
used for population-wide screening, taking into consideration and putting 
in place an adequate evaluation scheme to measure impact. This requires 
organising  specific  testing  intervals  for  repetition.  ECDC  will  support 
Member  States  in  this  context  through  the  publication  of  updated 
guidance  on  COVID-19  testing,  which  will  discuss  the  advantages  and 
challenges of population-wide testing and the use of rapid antigen tests in 
this context.  

7. 

Ensure that strategies are put in place that clarify when confirmatory testing by 
RT-PCR  or  a  second  rapid  antigen  test  is  required,  as  specified  in  the 
Commission  Recommendation  of  18  November  2020,  and  that  sufficient 
capacities for confirmatory testing are available.  

8. 

Ensure that the appropriate biosafety measures are in place, which includes the 
availability of sufficient personal protective equipment for healthcare personnel 

EN 

6 

  EN 

and other trained operators involved in specimen collection, particularly when 
rapid antigen tests are used in the context of population-wide screening and the 
number of testing operators involved is significant. 

9. 

Continue  to  monitor  developments  related  to  other  rapid  nucleic  acid-based 
tests  to  detect  SARS-CoV-2  infection18,  as  well  as  the  establishment  of 
serological-based diagnostic tests  and multiplex techniques.  If  required, adapt 
testing  strategies  and  approaches  regarding  the  use  of  rapid  antigen  tests 
accordingly.  In  addition,  developments  concerning  the  possibility  of  self-
sampling for rapid antigen testing, for example to address shortages in testing 
capacities and resources for sampling by trained operators, should be carefully 
monitored and addressed with support of ECDC  

10.  Continue  to  monitor  and  asses  testing  needs  in  line  with  epidemiological 
developments  and  the  objectives  defined  in  nationally,  regional  and  local 
testing strategies, and ensure that corresponding resources and capacities are in 
place to keep up with demands. 

Validation and mutual recognition of rapid antigen tests  

Member States should: 

11.  Agree on, maintain and  share with  the Commission19 a common  and updated 
list of COVID-19 rapid antigen tests that are considered appropriate for use in 
the  context  of  the  situations  described  under  point  6  and  are  in  line  with 
countries’ testing strategies, and that:  

(a)  Carry CE marking;  

(b)  Meet the minimum sensitivity and specificity requirements as defined by 

the Commission and ECDC.  

(c)  Have been validated by at least one Member State, providing details  on 
the methodology and results of such studies, such as the sample type used 
for validation, the setting in which the use of the test was assessed, and 
whether  any  difficulties  occurred  as  regards  the  required  sensitivity 
criteria or other performance elements.    

12.  Agree that the rapid antigen tests included in the common list referred to under 
point  11  is  updated  on  a  regular  basis,  particularly  as  new  results  from 
independent  validation studies  will become available and new tests  will  enter 
the markets.  

13.  Continue  to  invest  in  conducting  independent  and  setting-specific  validation 
studies of rapid antigen tests, with the aim to assess their performance against 
NAAT,  particularly  RT-PCR  assays.  Member  States  should  agree  on  a 
framework for such validation studies, for example by detailing the methods to 
be used and defining the priority areas and settings in which validation studies 
are required. Such a framework should meet the requirements as described in 

18 

19 

EN 

For  example:  RT-LAMP  (reverse  transcription  loop-mediated  isothermal  amplification),  TMA 
(Transcription Mediated Amplification) and CRISPR (clustered regularly interspaced short palindromic 
repeats). 

Commission database: https://covid-19-diagnostics.jrc.ec.europa.eu/ 

7 

  EN 

                                                 
the  ECDC  technical  guidance  on  rapid  antigen  tests20.  Member  States  should 
ensure  that  full  validation  data  sets  are  shared  where  possible,  taking  into 
account the relevant general data protection legislation. 

14.  Continue to cooperate at EU level in assessing the evidence gathered from the 
use of rapid antigen tests in clinical practice, including through the Joint Action 
EUnetHTA21 and other potential future cooperation mechanisms. 

15.  Agree  on  a  selection  of  rapid  antigen  tests  of  which  they  will  mutually 
recognise the test results for public health measures, based on the information 
included in the common list referred to under point 11.   

16.   Consider,  whenever  the  list  referred  to  under  point  11  is  being  updated, 
whether  any  rapid  antigen  test  should  be  removed  from  or  added  to  the 
selection  of  rapid  antigen  tests  of  which  their  results  are  being  mutually 
recognised.   

17.  Explore the need and possibility for the creation of a digital platform that can 
be used to validate the authenticity of COVID-19 test certificates and share the 
outcomes of such discussions with the Commission. 

Done at Brussels, 

For the Council 
The President 

20 

21 

Options  for  the  use  of  rapid  antigen  tests  for  COVID-19  in  the  EU/EEA  and  the  UK.  Stockholm  19 
November  2020.  ECDC:  Stockholm;  2020:  https://www.ecdc.europa.eu/en/publications-data/options-
use-rapid-antigen-tests-covid-19-eueea-and-uk 
https://eunethta.eu/ 

EN 

8 

  EN