Changes are coming to the way in which MHRA ensures the safety and quality of medical devices. A series of improvements are being made to modernise the current system that will ensure better protection of public health and patient safety.
The new Regulation for Medical Devices (MDR), which entered into force on 25th May 2017, will regulate certain groups of products without an intended medical purpose, listed under Annex XVI, as medical devices.
This means that, by 26th May 2020, certain groups of products, in line with all other medical devices, will be required to comply with the obligations set out in the MDR.
Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745)