Yes. Self test medical devices are strictly regulated in Ireland, having to comply with the requirements of the EU In-Vitro Diagnostic Directive 98/79EC (IVDD). All diagnostic tests sold by MyBio comply with these regulations and carry the CE mark to show compliance.

MyBio self tests have been assessed according to Irish and EU regulatory standards and by an independent Notified Body in Germany to ensure that our self tests give reliable results. All our tests use clinical grade components.

The MyBio Self Tests use the same immunoassay technology used in laboratories and hospital clinics across the world. MyBio has over 10 years experience working in this field. As always, it is essential to read the instructions carefully even if you have used similar devices in the past.

Yes - all MyBio Self Tests have undergone extensive user trials under the scrutiny of external scientists and doctors responsible for the regulation of medical tests in the EU to show that the tests are easy to use by the general public.

Yes. It is strongly advised to watch our ‘how-to’ videos – they can be viewed by scanning the QR code on each box and on MyBio’s YouTube channel. Nevertheless, always read the instructions!