Module 18 2021

08/02/2021

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 • Will need to find an EU Notified Body and Responsible manufacturer in the EU in order to retain and sell in the EU under CE mark

The Organisation for Professionals in Regulatory Affairs

9

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

10

5