The Brexit1 deadline has been extended once again – now to January
31, 2020 – and a withdrawal deal seems likely given the result of the December
12 general election. However, drug manufacturers and contract test laboratories
should be proactive in understanding the
potential regulatory considerations relating to commercial drug product release
testing and Brexit.
This article provides a brief overview of the EU-U.S. Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, U.K. and U.S. drug product releases if and when Brexit moves ahead.
How could a no-deal Brexit affect my medical device lifecycle?
Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario.
The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway. Continue reading