As part of the requirements for UKCA due to come into force in July 2023, the MHRA will designate UK Approved Bodies to conduct conformity assessments on their behalf to check compliance of IVD manufacturers against the requirements for UKCA marking. These UK Approved Bodies are not able to complete conformity assessments for CE marking as an EU Notified Body, or visa versa.
The full list of UK Market Conformity Assessment Bodies can be found here:
UK Market Conformity Assessment Bodies – GOV.UK (www.gov.uk)
UK Approved Bodies specifically for medical devices are listed here:
UK approved bodies for medical devices – GOV.UK (www.gov.uk)
Both databases will be updated frequently so it is well worth saving these links as a book mark!
The new UK regulation (MDR2002) text is expected in the coming months, however while you wait is it worth making some preparations:
- Identify stakeholders for any UKCA transition projects
- Collate information on your portfolio and sales figures to identify which devices will be transferred into UKCA, or discontinued
- Make initial enquiries with UK AB to understand their availability and timelines.
We are currently engaging with our customers providing workshops based on the impact of UKCA marking. For more information on how we can help you, contact us [email protected].
Happy Planning!