Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

AI Summary

This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for manufacturers and suppliers of medical devices, hand sanitisers, masks, and gloves in the Great Britain and Northern Ireland markets. While it is a general regulatory notice rather than a company-specific inspection report, it applies to all entities producing these goods. The regulatory framework includes the UK Medical Device Regulations 2002, the Human Medicines Regulations 2012, and the General Product Safety Regulations 2005. Products are categorized by intended use; for instance, hand sanitisers are classified as cosmetics, biocides, or medicines based on their specific claims. Face masks and gloves are regulated as either Class I, IIa, or III medical devices or as Personal Protective Equipment (PPE). The MHRA identifies major compliance issues such as the sale of products without valid UKCA, CE, or CE UKNI marks and the incorrect labeling of transparent face masks. Required actions for businesses include obtaining appropriate certifications from Approved or Notified Bodies, ensuring full compliance with technical standards like EN 14683 before making performance claims, and adhering to the extended acceptance deadlines for CE-marked devices, which run until 30 June 2030. Failure to comply can result in enforcement measures, including product seizures and criminal investigations. Companies are encouraged to consult with Trading Standards or the MHRA Medicines Borderline Section for specific classification advice.