As the EU regulatory framework for medical devices and in vitro diagnostic devices continues to mature, May 2026 marks a critical milestone for manufacturers operating under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Several high-priority deadlines will take effect during this month, requiring immediate attention to ensure ongoing compliance and uninterrupted market access. Below is an overview of the most important dates and their implications.
1 May 2026 – Mandatory Use of New MIR Template
Starting 1 May 2026, manufacturers must adopt the updated Manufacturer Incident Report (MIR) template for all vigilance reporting activities. This requirement aligns with the EU’s ongoing efforts to standardize post-market surveillance and improve the quality and consistency of incident reporting.
Failure to use the updated template may result in non-compliance findings during audits or delays in incident handling by competent authorities. Manufacturers should ensure that:
- Internal procedures are updated
- Relevant staff are trained
- Systems are aligned with the new reporting format
26 May 2026 – IVDR Application Deadline for Class C Devices
By 26 May 2026, manufacturers of Class C in vitro diagnostic devices intending to benefit from the extended transitional provisions under IVDR must submit a formal conformity assessment application to a notified body.
This is a critical regulatory checkpoint. Missing this deadline means manufacturers may lose eligibility for the extended transition period, potentially requiring full IVDR compliance sooner than anticipated.
28 May 2026 – Full Mandatory Use of 4 EUDAMED Modules
On 28 May 2026, the EUDAMED reaches a major implementation milestone, with mandatory use of several core modules becoming effective. These include:
- Actor Module – Registration of all economic operators
- Device/UDI Module – Device registration and Unique Device Identification
- Notified Bodies and Certificates Module – Transparency of certification data
- Market Surveillance Module – Reporting and coordination of regulatory activities
This transition represents a significant step toward increased transparency and traceability within the EU medical device ecosystem. Non-compliance could result in restricted market access or increased scrutiny from regulators.
