Safety recommendation
HSIB recommends that the Medicines and Healthcare products Regulatory Agency publishes guidance on the labelling and packaging of medical devices, to promote best practice and reduce selection of the incorrect item.
Response:
We have considered HSIB’s investigation report relating to the selection and insertion of vascular grafts in haemodialysis patients and noted the specific recommendations made to us. We agree that publishing MHRA guidance on the labelling and packaging of medical devices will promote best practice.
We are currently on track to introduce new regulations that will allow reform of the current requirements for labelling and instructions for use as part of the new UK Medical Devices Regulation by July 2025. The regulatory changes will be accompanied by guidance to support the MedTech sector in the interpretation of the new requirements. The new regulatory framework will ensure increased scrutiny on the packaging and labelling of implantable medical devices prior to UK marketing. Furthermore, post-marketing monitoring of the safety of implantable devices will be further improved through implementation of the upcoming Statutory Instrument on Post-Market Surveillance of Medical Devices in autumn 2024.
Action planned to deliver safety recommendation:
- Publish MHRA guidance on the labelling and packaging of medical devices by July 2025.
Response received on 13 November 2023.