Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Let’s look at a few perspectives

The Organisation for Professionals in Regulatory Affairs

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1. EU-based manufacturer

CE marked product: • EU manufacturers will need to appoint a UK Responsible Person as soon as possible after 1 Jan 2021 • UK Responsible person to register devices as per schedule • Import into UK for up to 2 years under current EU CE mark ( extension applies ), then the product must have a UKCA mark issued by a UK NB ( standstill applies ) • UK responsible person details will need to be included on the product labelling (this does not apply to CE-marked devices)

The Organisation for Professionals in Regulatory Affairs

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