The British Medical Devices and IVDs Associations recently published a letter to those involved in Brexit negotiations.
The letter aims to highlight the need for joint legislation between the European Union and the United Kingdom in the medical field.
There are therefore some factors that negotiators shall consider to ensure regulatory stability. For example, full implementation of the new European Regulations (MDR 745/2017 and IVDR 746/2017) in the United Kingdom and the recognition of UK Notified Bodies as competent Authorities by European Authorized Organizations are required.
For more information: