Ongoing UKCA work

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.

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