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Latest From Brexit
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.
Life science firms wanting to avoid possible blockages at the Channel ports if the UK leaves the EU without a deal are being advised by the BioIndustry Association to register now. Meanwhile the government has published a report that brings together all its advice on preparing for a no-deal Brexit.
With the current Brexit date less than a month away, the UK IVDs industry is busy providing support to UK manufacturers and the pathology sector in an attempt to ensure no one gets caught out. Coinciding with this are the ongoing preparations for the EU IVDR, and a raft of UK-specific issues for the diagnostics industry.
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