The MHRA have recently updated their Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain to:
- Reflect the current requirement for UKCA marking (section 3.15)
- Add UK approved bodies and UKCA mark/marking in the Conformity assessment procedure flow charts (section 3.11) instead of using CE mark/marking and NBs
The rest of this document remains the same. We recommend you review this guidance before placing products on the market in Great Britain to ensure you are in line with requirements.