Regulatory Intelligence

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.

Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Organizations involved in medical device compliance should prepare for potential future changes requiring MHRA-issued licenses for devices entering the market.