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Latest From Brexit
The Queen’s speech last month signaled new legislation for medical devices after the UK leaves the umbrella of EU legislation, following the December election result. The bill is expected to enter its second reading in March 2020.
The December 12 UK general election returned a Conservative majority, the scale or which few would have predicted. It means that the new government can press on with its plans for Brexit, the uncertainty now surrounding only when, not if.
BSI Netherlands is the seventh notified body to be designated under the EU’s Medical Device Regulation. But this latest announcement is one of the most important yet.
Risk management was the thread running through the ABHI’s annual regulatory conference. But the irrepressible theme of the MDR was the main draw for the 200 attendees, even though the MHRA and industry are still unaware of the shape of the UK’s future relationship with the EU.
Not all medtech certificates have been migrated from UK notified bodies to notified bodies in the European Union. The European Commission thinks the Brexit "flextension" may now give medtechs sufficient time to complete this process.
The consensus among the UK MHRA, the national medtech industry and notified bodies remains that convergence of regulatory systems is the preferred route for the UK once it has left the EU. Meanwhile, the regulator is planning for all eventualities, as a recent parliamentary forum on the post-Brexit regulatory landscape heard.
The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a checklist for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.
The Brexit withdrawal deal agreed by the UK and the EU on 17 October would see the UK leave the EU at the end of the month, but would allow time to negotiate the future trading and regulatory relationship between the two parties. However, the deal still faces a rough passage in the UK parliament.
Today is John Wilkinson’s last day as head of devices at the UK’s MHRA. It looks like his successor will be someone who can ably assist in the transition ahead, as the UK copes with upcoming Brexit arrangements and the EU attempts to successfully implement the new Medical Device and IVD Regulations.
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