Self-tests and Near-patient Tests: What EU Law Says

Self-tests (devices for self-testing) and near-patient tests have become an important aspect of healthcare, and not just since the coronavirus pandemic. However, there are still several uncertainties regarding their use: are the devices designed clear enough for laypersons to be capable using them correctly? Can they withstand ambulance and emergency room conditions?

This article will explain:

  • how self-tests and near-patient tests differ from other IVD devices
  • what regulatory requirements have to be complied with and
  • some tips you should follow to ensure that your IVDs pass the conformity assessment procedure with ease

1. What are classed as self-tests and what are classed as near-patient tests?

a) Definition of self-tests and near-patient tests

Self-tests (also “devices for self-testing”) and near-patient tests (also “point-of-care testing,” POCT) have a lot in common and are therefore treated similarly from a regulatory perspective. 


Self-tests are predominantly used by laypersons in their own home. They take the sample themselves and also perform the analysis on the spot using the self-test. 

Classic examples of this type of test are home pregnancy tests, cholesterol tests and coronavirus self-tests.

Definition: Self-test/device for self-testing

‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to laypersons by means of information society services

Source: IVDR Art. 2(5)

The “information society services” referred to in the IVDR’s definition would include, for example, apps that patients send the values measured with a self-test (e.g., hormones in saliva or urine) to and that then provide a recommendation for action based on the analysis of this data. The app could, for example, interpret longitudinal trends (e.g., state whether the patient is currently fertile or whether short-term or long-term insulin would be better right now). The app would then be considered an “information society service” and the software would be classified as a “device for self-testing.”

Near-patient tests

A near-patient test is in many cases similar to a self-test from a technical and use point of view. However, they are performed by medical professionals and not laypersons.

Unlike most self-tests, a lot of near-patient tests require an analytical device that is easy to use but involves complex technology. In most cases, they are not only too complex for laypersons to use, they are also very expensive to purchase.

Other near-patient tests use a pre-prepared test kit that is like a self-test. However, the sample is taken by a medical professional, e.g., a physician, paramedic, etc., and not by the patients themselves. Medical professionals also perform the analysis of the sample in the case of near-patient tests.

Examples would include rapid coronavirus tests in test centres or blood gas analysis in an emergency room or neonatology department, or CRP tests at pediatric centres to determine whether a child has an infection.

Additional information

Trillium Verlag has compiled a list of POCT systems that require an analytical device.

Definition: Near-patient tests

‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional

Source: IVDR Art. 2(6)

b) Difference from sampling kits

In the case of sampling kits, the sample is normally taken by a medical professional (as with near-patient tests) in, for example, a primary care centre and in exceptional cases by the patient themselves (as with self-tests). Unlike self-tests and near-patient tests, with a sampling kit the analysis is not performed on the spot. Instead the collected sample is sent to a medical laboratory that performs the actual diagnostic testing.

Therefore, the main difference is in the analysis: in the case of self-tests and POCT, it is done on the spot. In the case of the sampling sets, the analysis is performed by a centralized laboratory.

While self-tests and near-patient tests have a lot in common from a regulatory perspective, this is not the case for sampling kits. From a regulatory perspective, they are treated very differently from the other two test kit forms. 

Examples of self-tests, near-patient tests and sampling kits based on SARS-CoV-2 tests:

  • Self-tests: Antigen tests for own use, bought, e.g., in supermarkets, pharmacies or online.
  • Near-patient tests (POCT): Rapid antigen tests in a coronavirus test centre.
  • Sampling kit: Sampling kit sent to a practicing physician by a laboratory with a return box for sending the sample to the laboratory, which then performs a PCR test for SARS-CoV-2 RNA.

2. Regulatory requirements for self-tests and near-patient tests

There are several regulatory requirements that apply to both self-tests and near-patient tests, and a few that apply to only one type of test. 

a) Regulatory requirements that apply to both self-tests and near-patient tests

The regulatory requirements for the two types of test can be found in EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).

Specific usability requirements

As self-tests and near-patient tests are used in situ and not in a controlled laboratory environment, specific usability requirements have been defined for the tests (see, e.g., Annex I 19 IVDR). This is particularly true for self-tests used by laypersons.

For example:

  • Usability studies must be performed (Annex I 9.4)
    In the case of self-tests, for example, it must be demonstrated that laypersons can obtain reliable results.
  • Usability tests must be carried out in the use environment (Annex I 9.4)
    If the tests are intended for use in a wide range of environments, manufacturers must demonstrate that the test can be used reliably in the relevant environments. If the test can be used in an ambulance, for example, where there may be vibrations and temperature fluctuations, the checks must also be performed in that environment.
  • All individual devices must contain an instruction for use

According to Annex I 20.1(e) IVDR, each device must come with instructions for use. So, if a multipack contains 10 tests, each of these tests must come with a copy of the instructions for use, rather than just one copy of the instructions for use being provided for the entire multipack. This is still the case even if multiple devices are supplied to a single user. In addition, the instructions for use must identify the intended user (Annex I 20.4.1(e) IVDR).

  • The instructions for use must be provided in paper form (Annex I 20.1(f) IVDR)


There are specific requirements governing the labelling of the devices as well:

  • Easily understandable
    According to Art. 10(10) IVDR, the information on the label must be easily understandable (particular attention should be paid to usability) and in the official language(s) of the member state where the device is being made available.
  • Indication that the device is intended for self-testing or near-patient testing
    According to Annex I 20.2(q) IVDR, the label must contain an indication of the fact that the device is intended for self-testing or for near-patient testing.
    There are still no precise specifications as to what this indication should look like. For example, ISO 15223-1 does not yet provide a symbol for it. Therefore, “device for self-testing” as defined in Article 2 IVDR or, in the case of POCT, “for near-patient testing” should always be specified in text form. This approach is also recognized by the industry association MedTech Europe. MedTech Europe has compiled the proposed symbols in a PDF. 

In the application for assessment (conformity assessment procedure)

  • Evidence of usability with the application for assessment of the TD

The focus on usability is also reflected in the application for assessment of the technical documentation (TD) by a notified body. Therefore, according to Art. 48(3), (7) and (9) and Annex IX 5.1 IVDR, the assessment of technical documentation must be requested separately and usability studies must be included with the application. The technical documentation must also contain evidence that laypersons or medical professionals can use the device under stress in any circumstances (Annex II 3.1(e) IVDR).

  • Evidence of usability with the application for assessment by type examination

Similarly, according to Annex X 2 IVDR, the same applies to applications for conformity assessment by a notified body on the basis of a type examination. They should also include:

  • Test reports, including the results of usability studies
  • Information demonstrating the suitability of the device in relation to its intended purpose for self-testing or near-patient testing


According to Annex VI 2.14. IVDR, self-tests and near-patient tests must be registered in the EUDAMED database as devices for self-testing or for near-patient testing.

b) Special requirements for self-tests

The following requirements apply to self-tests in addition to the ones mentioned in section a):

Requirements according to the IVDR

Labelling and instructions for use

  • Clear name
    The name of devices for self-testing must not indicate an intended purpose other than the one specified by the manufacturer (Annex I 20.2 IVDR). The device must therefore be clearly named.

    Example: A coronavirus test for people aged 12 years and over must not be called a “coronavirus test for all age groups” as it is not intended for all age groups.
  • Label and instructions for use with specific information
    According to Annex I 20.2(u) IVDR, the following information must be indicated on the label (and not just in the instructions for use!) of devices for self-testing:
    • The type of specimen(s) required to perform the test (e.g., blood, urine or saliva)
    • The need for additional materials for the test to function properly
    • Contact details for further advice and assistance.
  • Additional usability requirements (Annex I 20.4.2. IVDR)

The following additional requirements also apply to the instructions for use that accompany self-tests: 

  • Sufficient information to enable the user to use the device and to understand the result(s) produced by the device.
  • An intended purpose that is comprehensible for laypersons.
  • A presentation of results that is comprehensible for laypersons.
  • Information on actions dependent on the test result (e.g., intervention (such as quarantine), recommended action (avoid certain allergens) or discharge (negative test result and therefore no restrictions))
  • Information on restrictions (for example, age, sex, menstruation, infections, exercise, fasting, diet, or taking of medication)
  • Additional information, some of which is member state-specific


Self-tests (devices for self-testing) fall into class C according to Annex VIII 2.4.(a) IVDR. Exceptions are: 

  • Pregnancy tests 
  • Fertility tests
  • Cholesterol tests
  • Devices for detecting glucose, red blood cells, leukocytes, and bacteria in urine. 

These fall into class B.

Performance studies

In the clinical performance study plan (Annex XIII 2.3.2 IVDR) manufacturers must provide information on where a clinical performance study will be conducted and the number of laypersons involved. In the performance study (see Annex I 9.4(a) IVDR) it must be shown that laypersons can derive the correct conclusions from the test results.

Additional regulations

  • According to the German MPAV (Medizinprodukte-Abgabeverordnung) §3(2)(3), professional advice must be provided (if required) if self-tests are supplied directly to laypersons.
  • Furthermore, according to MPAV §1 and §2, certain tests (especially if they contain prescription-only ingredients) are prescription only or are only available at pharmacies.


  • DIN ISO 18113-4 and ISO 18113-5 are worth paying attention to with regard to the labelling of self-tests.
  • ISO 20417:2021 on information to be supplied looks at specific features for lay users, among other things.
  • General information on self-tests: DIN EN 13532:2002-08 – General requirements for in vitro diagnostic medical devices for self-testing.
    However, this standard does not offer very much added value currently. Alternatively, manufacturers can use IEC 62366 and ISO 14971 as guidelines and adapt their principles to “self-tests” (brainstorming by the RM team based on the device characteristics).
    DIN EN 13532:2002-08 is included in the EU's harmonization mandate and should be harmonized by May 27, 2024. This means a helpful revision could be coming soon.

c) Specific requirements for near-patient tests


The specific requirements for near-patient testing defined in the IVDR relate to their classification: devices intended for near-patient testing are not all assigned to a single class (as is the case with self-tests). Instead, they must be classified according to their intended purpose (Annex VIII 2.4.(b) IVDR).


  • The (in parts) comprehensive CLSI POCT standard for point-of-care tests. POCT4-A2 Vol. 26 no. 30, for example, provides helpful considerations on the delineation of professional users’ responsibilities, test methods, safety, disposal, calibration and documentation. 
  • ISO/TS 22583:2019: Guidance for supervisors and operators of point-of-care testing (POCT) devices
  • DIN EN ISO 22870:2017-04: Point-of-care testing (POCT). This will soon be replaced by the new ISO 15189.
  • Medical laboratories that offer near-patient testing should also pay attention to the draft of EN ISO 15189:2021-11-15.

Additional information

For further research, we recommend the book Point-of-care testing: Principles and Clinical Applications by Peter B. Luppa and Ralf Junker (editors), 3rd edition.

3. Tips and hints

We have the following tips for you to help your self-tests and POCTs get through the conformity assessment process without any difficulties: 

Tip 1: Define the intended purpose clearly

The definition of the intended purpose needs to be clear for the performance evaluation.
There is a big difference between whether a test is used to detect a biomarker or to exclude it.

In the case of detection, the assumption is that the patient is positive (symptoms or risk group). In the case of exclusion, it is assumed that the patient is healthy. Performance evaluation criteria are derived from these assumptions: firstly, the criteria that determine whether a patient is a candidate for the test or not and, secondly, the acceptance criteria for performance, for example, the diagnostic sensitivity and specificity required.

Tip 2: Pay special attention to usability

From a regulatory perspective alone, usability should be high on the list of priorities when it comes to self-tests and near-patient tests. After all, it is the subject of a lot of IVDR requirements (see above). However, from a purely practical perspective as well, manufacturers should take into account that their device is intended for laypersons and/or use in uncontrollable environments.

A lot of self-tests and POCTs can only be used correctly after instruction. Therefore, safe and effective use is only possible with good instructions for use and, if necessary, after training. This means manufacturers should take special care to ensure the usability of the instructions for use and, if applicable, quick reference guide. 

The usability engineering process described in IEC 62366-1 should be followed.

Additional information

You can find more information in our article on instructions for use.


Contact our usability experts who will help you find usability problems early with a quick formative assessment, so you can avoid rework and problems during the conformity assessment.

Tip 3: Include the users in your risk management calculations

Self-tests have a higher potential for foreseeable misuse. Their use in unanticipated situations or locations also makes them high risk.

In the case of POCTs, in contrast, a change of user group is possible in some cases, for example, from nurses to carers for the elderly or pharmacy assistants.

Manufacturers must systematically analyse and manage these risks and document them in the risk management file. 

Additional information

You can find further information in our article on risk management

Tip 4: Check whether several kits can be evaluated as a group

If the use scenarios of comparable devices overlap significantly, manufacturers should check whether they can group them together in one usability study. But be careful: deciding what can be grouped together and what has to be tested individually is often difficult. So, make sure that the scenarios really are identical and that the corresponding intended purposes do not result in any further risks in the use scenarios. If you have any doubts, you can ask the experts at the Johner Institute. 

Example: If a manufacturer offers several different lateral flow tests as allergy tests and they all have the same test principle and test procedure and if the user groups and use environments have the same fundamental characteristics, the use scenario is identical and a generic device group can be evaluated for several devices.

5. Conclusion

Since it is difficult for manufacturers to predict how and where users will collect and analyse self-test and near-patient test samples, making them easy to handle is essential. The less users have to pay attention to and, therefore, the less they can get wrong, the more reliable the final results will be. 

Manufacturers of self-tests and near-patient tests should therefore definitely pay close attention to usability. The accompanying information (particularly the instructions for use) should also be understandable for all intended users, even under stressful conditions. As a result, manufacturers must plan usability studies at an early stage and with the required scope.

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