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Ongoing UKCA work

By January 28, 2022No Comments

We will now be taking part in Focus Groups hosted by MHRA, contributing to the group for Trade Associations and industry. This will span both medical devices and IVDs.

Our contributions to this group will align with the submission from BIVDA for the UKCA consultation which closed in November, but below is a list of the topics which we have requested to be involved in:

  • Classification rules: IVDs
  • Essential requirements
  • QMS, risk management, health institution exemption
  • Distance sales
  • Obligations on economic operators
  • UDI requirements
  • Obligations on approved bodies
  • Conformity assessments (including novel evidence types)
  • Equivalence
  • Performance evaluations
  • Post market surveillance requirements (including serious incident reporting)
  • Genetic testing obligations
  • Software as a medical device
  • Routes to the UK market
  • Transitional arrangements
  • Equality and diversity assessments, health inequalities
  • Combination products
  • Labelling, instructions for use, human factors and usability
  • Clinical evaluation
  • Standards and specification application
  • Sustainability
  • If you would be interested in these topics and could provide assistance if needed, please let Ashleigh know as soon possible. We expect these focus groups to begin in roughly the middle of February.