Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

2a. UK-based manufacturer

If using a UK Notified Body: • Can continue with CE mark for up to 2 years • Can transition to UKCA mark with existing NB during this time (standstill applies) • Will need to find an EU Notified Body and EU Authorised Representative in the EU in order to retain and sell in the EU under CE mark In Practice NB migration to EU offices.

The Organisation for Professionals in Regulatory Affairs

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2b. UK-based manufacturer

If using an EU Notified Body: …As with EU manufacturers Can continue with CE mark in the EU, and in UK for up to 2 years After that, will need a UK NB to review and issue a UKCA mark for the product

The Organisation for Professionals in Regulatory Affairs

12

6