Question to the Department for Exiting the European Union :

To ask the Secretary of State for Exiting the European Union, pursuant to the Answer of 03 December 2018 to Question 196736 on Medicines and Healthcare Products Regulatory Agency (MHRA) and with reference to the transition period set out in the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, if the MHRA will be recognised as an EU competent authority under EU Regulations (a) Medical Devices Directive, (b) in-vitro diagnostic medical devices, and (c) Medical Devices Regulation during that period.

The agreement of an implementation period will mean that the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be recognised as an EU competent authority designated under the EU Directives for medical devices, in vitro diagnostic medical devices and active implantable medical devices, during this period.

This is also the case for the new EU Regulations for medical devices and in vitro diagnostic medical devices, which both entered into force in May 2017.