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Latest From Brexit
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 check list 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.
MDR implementation activity is fast and furious now. This roundup for September summarizes not only our most popular stories but also updates readers on the news that occurred as the month-end approached.
In just five weeks’ time, there is the risk that the UK, including Northern Ireland, could depart the EU. But where does the Republic of Ireland stand and what is it advising in these uncertain times?
Authorized representatives will no longer be legal entities in the UK if there is a no-deal Brexit, leaving manufacturers outside the EU potentially stranded. These manufacturers must ensure instead that they employ a "UK Responsible Person" and avoid being caught by the deadlines.
There are six weeks or less for medtech companies to be ready to operate as well as they can under Brexit – assuming that it will take place at the third time of asking. The new NHS procurement scheme, already in place, is another potentially disruptive concept for UK companies to adapt to.
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