The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021).
We are currently working through the details and planning resources; at this time, we would like to ask you about your current plans to allow us to assign the required capacity. Please could you take 10 minutes to complete our survey to support resource planning as a possible UKCA Approved Body?
What do I need to do now?
Tell us about your UKCA Plans by completing this short questionnaire.
Please complete this by Friday 6 November 2020.
Where can I find more information on UKCA?
Who can I contact for further information?
If you have questions or concerns, further information can be provided via your BSI Scheme Manager. They will be able to answer your questions in the first instance, and we recommend you use the free material referenced.
Dr. Michael Weissig
Global Vice President Commercial Operations