Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that known allergens and perfumes present in condoms are labelled on condom packaging.
The Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its work to strengthen the regulation of medical devices in the United Kingdom and ensure medical devices are safe and effective. A condom is a medical device, and medical devices placed on the UK market are subject to rules requiring labels and instructions for use to contain precautions related to certain materials in the device that could result in sensitisation or an allergic reaction.
The MHRA undertakes a range of compliance and enforcement activities to ensure medical devices being placed on the UK market meet relevant regulation requirements. Once a medical device is on the market, the MHRA continuously monitors their safety, including via reports of suspected adverse events associated with medical devices received through the Yellow Card scheme. Should any new safety concerns be identified, we will take necessary regulatory action to minimise these and ensure the benefits of use continue to outweigh the risks.