SEHTA

SEHTA and Psephos latest MDR webinar is on CE & UKCA Marking.  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).

Why attend?

The 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:

• A 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
• From 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
• CE Marking will continue to be used and recognised until 30 June 2023
• If 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

This webinar will also provide an overview of CE Marking:

• MDR CE Marking Process and the role of a Notified Body and Competent Authority
• MDR Device Classification
• MDR Conformity Assessment routes for class I, IIa, IIb and III products
• Compiling Technical Files, Clinical Evaluation Reports & the Declaration of Conformity
• Clinical Investigations

Target 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.