Chicago Chapter Webcast: Regulation of Medical Devices and IVD’s in the UK

RAC Credits
Monday, 08 February 2021 (11:00 AM) - Monday, 08 February 2021 (1:00 PM) Central Time (US & Canada)

Member: $10
Nonmember: $25


Since 1 January 2021, there have been several changes regarding how medical devices are placed on Great Britain's market. All medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market, will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). 

For manufacturers outside of the UK who wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. Even though CE marking will continue to be recognised in Great Britain until 30 June 2023, manufacturers must start to prepare for complying with the relevant product marking and conformity assessment requirements for medical devices and IVDs.

This webinar will highlight the new compliance requirements for: 

    • UK Responsible Person
    • UKCA mark and Conformity Assessment Bodies
    • Registering your device with the MHRA
    • Labelling requirements
    • Post-market surveillance and vigilance

This presentation will feature a Q&A session in the middle and end of the webcast.

This event is brought to you by the RAPS Chicago chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: Intermediate 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. This presentation will feature a live Q&A session in the middle and end of the webcast.

Featured Speaker:
Philippe Auclair, Pharma Dr, PhD, FRAPS, senior director regulatory strategy EMEA, Abbott

Thank you to our Platinum Chapter Sponsor: