Prepping For Brexit With Notified Body Switch Could Be Unnecessary Expense, BSI Warns
While there are some warnings that UK medical device companies should be jumping ship, and taking worst-case Brexit scenarios seriously, major notified body BSI believes there is too much scaremongering, and that a less disruptive EU-UK agreement is likely.
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With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.
UK and EU leaders announced some progress on Brexit this week, establishing a conditional transition period after the UK exits the Union in 2019. But that does not resolve many questions and concerns in the medtech space about what's to come. Here is a comprehensive look at where things stand for medtech, based a discussion from this week's Device Week podcast.
2018 has had a bumpy start in the realm of EU regulations. The tangled Brexit issue has some in industry playing Russian roulette, while other deadlines are causing concerns. These issues and more were covered in the most popular Medtech Insight EU regulation stories from January.