Top headlines across the medical devices sector this week include what exporters need to know about the CE Mark post-Brexit, the wearable tech errors worrying well people, and warnings of inaccessibility of devices in a no-deal Brexit. Read more -
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A recent study using the Apple Watch found that for every 100 patients who were notified that they had an irregular pulse, the device was wrong in 16 cases.
The ‘CE Mark’, standing for ‘Conformité Européenne’, has long been used by UK manufacturers, distributors and suppliers for moving certain goods around Europe.
As much as 40 per cent of medical devices used in the Republic will not be accessible in the event of a no-deal Brexit because authorised bodies in the UK won’t be recognised by EU regulators after April 12th, according to a leading global player in this space.
The Global Medical Device Nomenclature, the de facto global standard for identifying the world’s medical devices, has been made freely available to all manufacturers for the first time from this week.
The US Food and Drug Administration proposed a framework on how it might regulate medical devices that rely on AI and machine learning algorithms.
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