The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an advisory to healthcare professionals, instructing them to cease the use and supply of specific medical devices. These devices have been supplied to the UK market without the necessary conformity markings, which are required under the UK Medical Devices Regulations 2002 and the EU Medical Devices Regulation (EU) 2017/745.
The affected products encompass items used in clinical settings for various procedures, including blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation. While the MHRA has not identified any specific defect, performance, quality, or safety issues with these products, the absence of appropriate conformity assessment means there is insufficient reassurance that they meet UK regulatory requirements or expected standards for quality, safety, and sterility.
Organisations and individuals are urged to check their stock for any of the listed devices. If found, they should immediately stop using and supplying them, quarantine any remaining stock, and switch to compliant alternatives. Distributors have also been advised to stop further supply and notify the MHRA of any affected products received or distributed.