Covid-19 has focused the minds of politicians and the general public for the last 6 months. During the pandemic, coverage of the UK’s departure from the European Union took a back seat. Now, as the number of reported cases is declining, the focus is shifting back to the UK’s departure from the transition period at the end of 2020. We have updated our no-deal whitepaper from 2019. The whitepaper looks at the impact of the UK’s departure on the pharmacovigilance, medical devices, and clinical trial sectors.
Our pharmacovigilance team looks at the measures that companies need to put in place now if they are to prepare for the UK leaving the EU without a deal. The role of the QPPV has been much discussed in recent years, since the outcome of the referendum became known, and companies need to be aware of the implications that Brexit will have on that role.
Brian Cleary from Acorn Regulatory spoke about the whitepaper when it was first published in 2019. You can see the video below.
The medical devices team look at the role of the EU Authorised Representative and the implications for Notified Bodies. The devices sector is in a particular ‘state of flux’ at present with the introduction of new legislation due to come into force in 2021 (delayed during the pandemic) and Brexit adds to the issues that device manufacturers need to be mindful of at this time.
Finally, our medical team looks at the impact on clinical trials. Trial sponsors and partners need to be aware of the impact of Brexit and the article contained in the whitepaper looks at what needs to be considered.