Thu, 15 Oct|
Brexit/UKCA Marking Webinar
SEHTA and Psephos are are running this FREE TO ATTEND webinar on Brexit/UKCA Marking.
Time & Location
15 Oct 2020, 14:00 – 14:30 BST
About the event
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.
This webinar will be be delivered via Webex.
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 detail on the UK Responsible Person