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Latest From Brexit

EU MDR: Medtechs Must Look At The Bigger Picture Of Regulatory Compliance

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.

EU Medical Device

Reprieve For Life Sciences As Brexit Deal Approved

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.

United Kingdom Brexit

Graeme Tunbridge To Lead MHRA Devices Unit During Interim, Reports Indicate

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.

Medical Device Europe

Register Now For No-Deal Brexit Ferry Routes, Says BIA

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.

Brexit United Kingdom

UK IVDs Broach Brexit Preparedness In Case Of No-Deal EU Exit

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.          

United Kingdom Medical Device

EU Regulatory Roundup, September 2019: Commission Massively Ramps Up Implementation Readiness

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.

EU Medical Device

Where Ireland Stands With No-Deal Brexit As It Acts To Protect Potentially Vulnerable Devices

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?

Europe Ireland

What The UK Responsible Person Update Actually Means For Industry

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.

Brexit Europe

Brexit And UK Procurement: Be Ready For Day 1

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.

Brexit United Kingdom
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