The MHRA have recently published a summary aimed at manufacturers of class I medical devices. In this online post, the MHRA places emphasis on the technical documentation required to demonstrate conformity to the Medical Device Directive, it describes the obligations of the manufacturer to perform a clinical evaluation, and highlights the additional prerequisites for class I devices that possess either a sterile or measuring function. The summary concludes with the post-market surveillance activities, corrective actions and vigilance procedures that must be implemented and maintained by the manufacturer.
See full publication at: https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices
If you have a class I medical device and are unsure of the full responsibility of a legal manufacturer of such devices, do get in touch with the Medical Device Team at Regulis.