Month: November 2019

Your Consultant on UK Regulation

Is the Irish health sector prepared for an eventual Brexit?

If you are an Irish undertaking producing or exporting medical devices into the European Union or you are simply willing to extend your market, this article is for you. It is a fact that the Irish Health Products Regulatory Authority is in close cooperation with its correlative Department of Health to plan, alongside stakeholders from…
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Spain is ready for Brexit: new checklist for Medical Devices and Cosmetics

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sector of: Medical Devices: Devices with a Notified Body (NB) established in the UK: manufacturer must ask for a new Certificate from a EU27 NB or for the transferal of…
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