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Clinical study sponsors may become non-EU post-Brexit

December 8, 2020 By Danielle Kirsh

By Ronald Boumans, Emergo Group

The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and study subjects (patients) may find themselves on different sides of a new EU outer border. Where the single market relies on one set of rules, different rules will apply for different markets–newly defined in the EU and UK as of January 1, 2020.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.

Filed Under: Regulatory/Compliance Tagged With: blog, Emergo Group

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