Readability testing

Legimate and clever test designs for your Pil / IfU / SSCP readability test (M.1.3.4).

Readability Test PiL for your Module 1.3.4

Knowhownow – readability test professionals since 2006

Readability test Leesbaarheidstest Lesbarkeitstest Test di leggibilità Teste de lisibilité Läsbarhet testet

Knowhownow is a European Group of Readability test professionals, based in the Netherlands. Since 2006, we have guided over 1000 package leaflets to submission. Knowhownow conducts your PIL user tests in the UK,  France, Germany, Belgium, USA and the Netherlands. We are well known for our state of the art quality and flexibility. We conduct our readability tests and IfU tests on patient instruction leaflets by guidelines issued by MhrA, EMA, AIFA, CBG-MEB, PEI, Bfarm, MSNA, FAGG.

Furthermore we have quite a track record concerning our success rate: 100% of our PIL user tests have been validated by various authorities. We continue to receive sincere compliments from the authorities on the quality of our extended reports. Submission ready for your M.1.3.4.

Readability test


Services Readability Test Pil – PIL user tests


– regular 6 -7 weeks 

– expedited 4 weeks (subject to additional fee)

Services :

– eCTD friendly dossier

– EMA and MHRA compliant reporting.
– Merging of all documents into 1 PDF for submission (m.1.3.4)
– Independent review of leaflet and mock-up.
– Rewriting of the leaflet upon request.
– Recruitment of 20 fresh – native users / consumers
– Preparation of protocol / questionnaire
– Arranging interview facility, all 20 interviews are held under the same conditions. Any disturbances are documented.
– Conducting of the interviews.
– Reporting within 2 weeks after fieldwork
– Printing of the mock-up in small batches
– Secure AVG / GDPR
– Documenting of individual detailed social demografic data of respondents (though not mandatory yet, we experience this is required by EMA and MHRA assessors more and more often).
– Documenting subjective ease of finding, PEI mandatory

Additional services:

Testing design

– Pilot testing of PiL or protocol

– Mock up design: we comply with all National Agency Specifications as well as your company’s design specifications
– Review of the Word text. Amendments are based on technical readabilitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use). Generally prioir to testing.
– PIL reformatting to current QRD
– 3D mock-up preparations

Bridging statements

Interested? Ask for quotation

Mock-up m.1.3.4.


Experience since 2006


Tested Leaflets


Success rate

For a readability test find our fieldwork sites in (but not limited to):   


United Kingdom: London, Bishops’ Stortford


France: Clichy, Paris, Colmar


 SwedenUmeå, Malmö


Germany: Dusseldorf, Kleve


The Netherlands: Nijmegen, Mook


Belgium: Liège

National authorities dealing with readability test

Netherlands: Leesbaarheidstest CbG-MeB https:\\
Germany: Lesbarkeitstest Bfarm https:\\
Denmark: læsbarhed test Danish Health and Medicines Authority https:\\
France: test de lisibilité ANSM https:\\
Finnland: luettavuus testi Fimea https:\\
IrEland: Readability test HPRA https:\\
Italy: test di leggibilità AIFA https:\\
Norway: lesbarhet test Norwegian Medicines https:\\
Spain: test de legibilidad SAMH https:\\
Sweden: läsbarhet testet Medical Products Agency htps:\\
UK: Readability test MHRA https:\\


Readability tests

For manufacturers of medicines, Europe requests to present the leaflet in one language to consumer panels. When we test a package leaflet for readability, attention is paid to findability, comprehensibility and applicability of the information. The readability test may be a reason to further improve a package leaflet.

The readability test is a mandatory part of the European registration procedure and the test results are included in the registration dossier. Knowhownow tests package leaflets according to a fixed procedure that is based on the guidelines of the European Commission. Your contribution is very important.