Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Northern Ireland Protocol

● CE Marking will remain a requirement for NI ● In some circumstances it will be required to inform MHRA when placing a device on the NI market ● If NB assessment required: – If EU Notified Body assessed, then CE mark will be used – If UK Notified Body assessed, then UKNI mark will be required, in addition to CE Marking ● Goods bearing the “CE UKNI” marking will not be accepted on the EU market

The Organisation for Professionals in Regulatory Affairs

15

And for Medicines?

GB is no longer a part of EU procedures such as Centralised, Decentralised and MRP MHRA has implemented some new procedures for registration of medicines to facilitate applications in the UK

The Organisation for Professionals in Regulatory Affairs

16

8