Ongoing dual compliance requires:
- Maintaining PMS systems for both GB (UK MDR PMS requirements) and NI (EU MDR PMCF and PSUR requirements)
- Vigilance reporting to MHRA (for GB incidents via MORE) and the relevant EU authority (for NI incidents via EUDAMED)
- Keeping both sets of technical documentation current
- Renewing certificates with both UK Approved Bodies and EU Notified Bodies before expiry