MHRA medical-device reclassification — why honey dressings are worth watching

The MHRA's UKCA framework continues to diverge — slowly — from EU MDR. For honey-based wound dressings classified Class IIb, the practical questions are: does the existing CE Technical File transfer, what additional clinical evidence does MHRA expect, and how does the UKCA-marked product label differ from its CE-marked twin?

The current position

MHRA continues to accept CE marks on a transitional basis for most Class IIb devices, but new entrants and post-2030 supply will need a UKCA pathway. The clinical evidence bar is converging with MDR — real clinical investigations, not just literature reviews — and honey dressings, like any topical antimicrobial device, sit squarely in that scope.

What to monitor

• MHRA guidance updates on Class IIb post-market clinical follow-up.
• UK-Approved Body capacity (a known bottleneck through 2026).
• Whether MHRA continues to harmonise with EN ISO 10993 biocompatibility and EN ISO 11137 sterilisation, or diverges.

For manufacturers shipping into both markets, the working assumption should be: maintain a single Technical File that satisfies the stricter of the two regimes (currently EU MDR), and document the UKCA delta separately.