Short answer: An EU manufacturer whose aesthetic light device falls within the medical-device framework needs an incident process that uses current vigilance materials, not an obsolete blank form copied into a quality folder. The European Commission’s post-market surveillance and vigilance page says the manufacturer incident report (MIR) form 7.3.1 became mandatory on 1 May 2026. It lists accepted releases from December 2025 through May 2026 and says older versions can no longer be used. The point for buyers is not to fill in an MIR themselves, but to confirm that the responsible manufacturer can receive, assess and report safety information for the exact device.
What changed in 2026
The Commission page identifies a 7 May 2026 update to the MIR PDF 7.3.1 materials. It specifically lists acceptable December 2025, March 2026, April 2026 and May 2026 versions, pending any further notice, and says pre-December 2025 versions are no longer usable. It also provides technical files for manufacturers implementing reporting in their databases, help text and a change log. Other listed materials cover field safety corrective actions, field safety notices, customer replies and trend reports. These are distinct documents for different safety workflows; simply having a complaints inbox is not the same as maintaining a reporting system.
This source applies where the relevant EU medical-device obligations do. Some aesthetic products without an intended medical purpose may come within the MDR through Annex XVI and its common specifications; others may fall under different product rules. The Commission page is a forms library, not a decision tree for classifying a laser, IPL, LED or RF device. A business should establish the device’s actual status and the roles of manufacturer, authorized representative, importer and distributor before assigning vigilance tasks. This article does not classify any TUOKE model.
A practical supplier conversation
Ask who receives complaints from users, how an incident is linked to a model and serial or batch, who evaluates reportability, and how competent authorities and affected customers are informed when necessary. Ask for a documented route for a field safety notice and for records of corrective actions. A distributor should know how to forward information quickly and accurately, rather than promising on its own to decide whether an event is reportable. The manufacturer’s process should identify the current form version and a way to monitor later Commission updates.
For a buyer operating several device types, keep the record specific. A heat-related complaint from RF equipment, an eye-exposure concern during laser work and a software fault should not be flattened into one undifferentiated “beauty machine” ticket. Preserve the product’s intended use and configuration, because those details can matter to investigation and reporting. That is an operational inference from the Commission’s vigilance framework, not a statement that every complaint requires an MIR.
Limits
The current form version is a 2026 process update, but the Commission page does not say that a device is safe, effective or legally marketable merely because a company owns the form. It does not provide a deadline or reportability judgment for a particular event. Qualified EU regulatory advice is needed for the actual device and incident. This is neither legal advice nor evidence of TUOKE certification, and the source should be rechecked before using forms in the future.
See the TUOKE optical aesthetic equipment insights for adjacent buyer questions.
Source
European Commission, PMSV reporting forms, MIR section updated 7 May 2026; reviewed 15 October 2026.