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SUMMARY:CE & UKCA Marking Webinar
DESCRIPTION:SEHTA and Psephos latest MDR webinar is on CE & UKCA Marking.  We have developed this 2-hour webinar in light of the new UK product marking that will be used for goods being placed on the market in Great Britain (England\, Wales & Scotland). \nDate: Thursday 14th January 2021 \nTime: 14:00 – 16:00 (GMT) \nWebinar platform: WEBEX \nCost:  Early Bird Rate: Book by 30th November \nSEHTA Members: £115+VAT pp \nSEHTA Non-Members: £130+VAT pp \n\n\n\n\n\n\n\n\n\n\n\n\n\n\nWhy attend? \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 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\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\nCE Marking will continue to be used and recognised until 30 June 2023\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 details on the UK Responsible Person\n\n  \nThis webinar will also provide an overview of CE Marking: \n\nMDR CE Marking Process and the role of a Notified Body and Competent Authority\nMDR Device Classification\nMDR Conformity Assessment routes for class I\, IIa\, IIb and III products\nCompiling Technical Files\, Clinical Evaluation Reports & the Declaration of Conformity\nClinical Investigations\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. \nFor more information\, and to book\, click here
URL:https://staging.medilinkmidlands.com/event/ce-ukca-marking-webinar/
CATEGORIES:Medilink Partner Event
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