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SUMMARY:Brexit/UKCA Marking Webinar
DESCRIPTION:SEHTA and Psephos are pleased to bring you this FREE TO ATTEND webinar on Brexit/UKCA Marking. \nThe UKCA (UK Conformity Assessed) Marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England\, Wales and Scotland).  It covers most goods which previously required the CE Marking\, including medical devices and in vitro diagnostics.  Therefore\, from 1 January 2021\, there will be a number of changes to how companies will be able to place medical devices on the market in Great Britain. \nThursday 5th November 2020 \nTime:   14:00 – 14:30  (BST) \nCost:    Free to attend \nFacilitator:   Jacques du Preez\, Director\, Psephos Biomedica \nThis webinar will be delivered via Webex.\nFrom 1 January 2021\, there will be a number of changes to how companies will be able to place medical devices on the market in Great Britain which will include: \n\nA new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021\n\n\nFrom 1 January 2021\, all medical devices and in-vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering – 4 months for Class IIIs and Class IIb implantables\, and all active implantable medical devices; 8 months for other Class IIb and all Class IIa devices; and 12 months for Class I devices\n\n\nCE Marking will continue to be used and recognised until 30 June 2023\n\n\nIf you are a manufacturer based outside the UK and wish to place a device on the UK market\, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person\n\nTarget audience:  Manufacturers based outside of the UK wanting to access the UK market\, UK based manufacturers wanting to access the EU market\, Medical Technology Entrepreneurs\, Medical Device Software Developers\, Technology Transfer Officers\, Medical Technology University Researchers\, IVD Developers\, Business Owners\, Executives\, Product Owners\, Regulatory Specialists within a company that need to understand the overall regulatory requirements for their medical devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful. \nPlease note that places are limited & the organisers have the right to review all applications.  \nClick here to book
URL:https://staging.medilinkmidlands.com/event/brexit-ukca-marking-webinar/
CATEGORIES:Medilink Partner Event
ORGANIZER;CN="SEHTA":MAILTO:info@sehta.co.uk
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