Short answer: A manufacturer of an EU Annex XVI aesthetic device cannot simply cite favorable data from a different medical light device and call the products equivalent. The Medical Device Coordination Group’s MDCG 2023-6 guidance explains how equivalence must be demonstrated for products without an intended medical purpose. Its distinction is especially useful when a sales deck cites studies on a clinically used laser or a different LED product to support a cosmetic-only device.
What the guidance says
The December 2023 document addresses clinical data from existing devices used in conformity assessment under the EU Medical Device Regulation. For two products without an intended medical purpose, it says equivalence should consider technical, biological and clinical characteristics under the MDR. In the clinical comparison, the shared purpose, body site, population, type of user and relevant critical performance still matter. A matched wavelength alone does not establish that two systems deliver the same exposure or produce the same intended effect.
The document takes a narrower position on comparing a non-medical product with an analogous medical device. In general, it says the demonstration of equivalence cannot be completed between them because medical clinical characteristics, such as disease severity and stage, do not have a counterpart in the non-medical product. Data from a similar medical device may still help risk management, an understanding of the state of the art or the scope of evaluation. That is not the same as using its results as a shortcut to establish full equivalence. For a dual-purpose comparator, the guidance says only characteristics and data related to the non-medical purpose should be used for the relevant comparison.
What to request from a supplier
Ask the manufacturer to identify precisely which studies concern the exact model and which concern a comparator. For any comparator, request a documented table of intended purpose, body site, user population, energy delivery, accessories, treatment schedule, relevant biological contact and outcome measures. Then ask whether the evidence is being offered as direct evidence, as a formal equivalence argument or only as background. These are different claims. A distributor’s phrase “same technology” is not an adequate equivalence rationale.
This framework matters for lasers and IPL systems used for aesthetic skin treatment where Annex XVI and its common specifications apply. It should not be generalized to every LED mask, every RF device or every light-emitting consumer product without first establishing the applicable scope. A buyer should also consider post-market monitoring and real-world operating conditions; a literature table does not replace a complete device-specific technical file.
Limits of the document
MDCG 2023-6 is guidance endorsed by the Member State coordination group, not legally binding EU legislation, and the document itself says it does not express an official Commission position. It was published in 2023, not newly issued in 2026. Interpretation of the MDR and common specifications for a particular product requires qualified EU regulatory advice. Nothing in this source assesses a TUOKE model, and this article makes no claim of TUOKE conformity, clinical performance or EU authorisation.
For more evidence-screening ideas, read the optical aesthetic equipment insights archive.
Source
- MDCG 2023-6, Guidance on Demonstration of Equivalence for Annex XVI Products, dated December 2023; reviewed October 13, 2026.