Amendments to the Devices Law on “Misleading or Unsubstantiated Claims” have been enacted by the MHRA following a lengthy investigation by the NIHR Biomedical Research Centre: Birmingham Diagnostic team.
The amendment will remove tests from the market that mislead users regarding intended use, safety, or performance; when supporting evidence is inadequate or when it fails to inform of significant risk, whether in labelling, packaging, instructions for use, or promotional or sales materials.
BIVDA strongly supports the team’s work in helping to drive change in medical device law.
As the UK industry association representing the in vitro diagnostics sector and companies operating in the UK, we strongly support efforts to ensure that only safe, effective tests supported by robust evidence are available on shelves and online for patients and consumers in the UK.
Self-testing can play a valuable role in helping people to take an active interest in their health and maintain healthy lifestyles, but it is essential that tests are accurate, appropriately regulated and accompanied by clear information so that results can be interpreted and acted upon appropriately.
We would also emphasise that self-tests are not a substitute for clinical advice. If patients are feeling unwell or receive abnormal results, they should consult a healthcare professional to ensure they receive the appropriate follow-up, diagnosis and care.
