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Start with intended purpose, not “cosmetic only”

Annex XVI is specifically concerned with listed groups of products without an intended medical purpose. Group 5 covers high-intensity electromagnetic radiation equipment used on the human body for skin resurfacing, tattoo or hair removal, or other skin treatment. The MDR also addresses devices with both medical and non-medical purposes. [1]

Read the manufacturer's purpose across the label, instructions for use (IFU), promotional statements and clinical evaluation—not just a disclaimer. Those materials form part of the MDR definition of intended purpose. [1] As a practical review step, preserve the wording and flag contradictions instead of selecting whichever phrase gives the simplest answer.

The relevant common specifications (CS) are in Annex VI of Regulation 2022/2346; this is a different annex from Annex XVI of the MDR. The CS scope includes skin rejuvenation and distinguishes acne-scar treatment from other acne treatment. It excludes infrared equipment intended to warm the body and sunbeds from this annex. An exclusion from this CS annex is not a finding that all other legislation is inapplicable. [2]

Qualification asks whether the product is covered. Classification asks which risk class applies once coverage is established. The MDCG explicitly places qualification first. [4] Missing evidence leaves the question unresolved; it does not grant permission to market or use the device.

Keep binding law and explanatory guidance separate

The European Commission's dedicated manufacturer page brings the CS, amendment and reclassification instruments together. It is a useful starting point for finding the legal texts, rather than a model-specific conformity decision. [6]

What does “high intensity” mean for LED equipment?

MDCG 2023-5 explains that infrared, visible and ultraviolet are examples of radiation types, not sufficient evidence of high intensity. Its proposed qualification approach asks whether the radiation can produce the effect on target tissue necessary to achieve the product's intended purpose. The possible effects include thermal and photochemical effects; the list is not exhaustive. [4]

This is not a wavelength-only test or a universal marketing-wattage cutoff. A review should connect the stated purpose, actual output under intended conditions and supporting tissue-effect evidence. “Red,” “non-thermal” or “low power” is not, by itself, a documented scope assessment.

Why the LED examples matter—and what they do not prove

The guidance includes LED equipment for skin rejuvenation, hair-growth stimulation and improving the appearance of acne scars, including LED face masks, in its group 5 classification examples. It also warns that examples do not establish qualification in advance. [4]

These examples rule out a simple claim that LED technology is categorically excluded. They do not establish that every mask, panel or LED mode qualifies. Nor do they demonstrate clinical effectiveness for an individual model. Keep ordinary LED emission, ultraviolet exposure, intense pulsed light (IPL), lasers, photodynamic therapy and infrared warming distinct when reviewing evidence; shared regulatory language does not make their performance data interchangeable.

Only after qualification: check the applicable class

For covered active group 5 products without an intended medical purpose, Article 1(a) of Regulation 2022/2347 assigns class IIb for skin treatment, with class IIa when intended for hair removal only. The word “only” matters: the exception is not a general class for cosmetic LED equipment. [3]

A regulatory reviewer should document the route for the actual product and its full intended purposes. Do not copy a class from another device that happens to use the same light source. A risk-class statement also does not establish that conformity assessment is complete or that a certificate covers the model, mode and purpose being discussed.

Documents to assemble for a qualified review

Use this as an evidence-gathering checklist, not a substitute for the manufacturer’s technical documentation or a legally exhaustive compliance list. Its purpose is to make the qualification and classification reasoning traceable.

A useful written conclusion identifies the product and documents reviewed, records qualification first, then the classification basis, and lists missing evidence. If the supplied file cannot support a conclusion, the review should say so explicitly rather than treating absence of proof as exemption.

Transitional provisions need their own evidence

Regulation 2023/1194 amended the transitional provisions in 2022/2346. A future end date is not a general grace period for every newly introduced LED product. [5]

When a manufacturer relies on transition, ask for the specific Article 2 route and evidence for every applicable condition. The clinical-investigation and no-clinical-investigation routes differ. Records may need to establish lawful prior marketing, continued compliance, absence of significant design or purpose changes, and the applicable investigation or notified-body milestone. Check the amended provision for the date of the proposed transaction; do not apply another product's timeline by analogy. [2] [5]

No transition eligibility has been established for any particular device in this article.

Common shortcuts to avoid

• “No medical claims means no MDR.” Annex XVI provides a route for listed non-medical products.
• “Every LED mask is class IIa.” Qualification comes first; the group 5 IIa exception is for hair removal only.
• “The wavelength settles high intensity.” The guidance connects the question to the intended tissue effect.
• “A future deadline proves this product can be supplied.” Transition depends on the applicable route and supporting records.

These shortcuts conflict with the scope, reclassification or transition distinctions above. [1] [3] [4] [5]

FAQ

Does a CE mark allow an aesthetic practitioner to use the device anywhere in the EU?

Do not infer that permission. MDR Article 1(14)–(15) preserves Member State powers and relevant national rules about device use and healthcare delivery. Verify the applicable country requirements separately; this article has not established any practitioner’s entitlement. [1]

Can one purpose statement cover every mode of a multifunction device?

A review should map each claimed purpose and relevant mode to supporting documentation. The MDR requires devices with both medical and non-medical purposes to meet the applicable requirements cumulatively. A general cosmetic statement cannot resolve a contradictory medical claim elsewhere in the file. [1]

Where should a reviewer look for updates?

Use EUR-Lex for the legal texts and the Commission’s current guidance directory for endorsed guidance and revisions. On the verification date, that directory listed MDCG 2023-5 and the revised general classification guidance MDCG 2021-24 rev.1. Check the actual documents relevant to the case; a saved 2023 guide is not a complete update check. [7]

The next step: a documented device-specific conclusion

Give a qualified regulatory reviewer a consistent file showing purpose, technical operation and evidence. Ask for a traceable scope decision before a risk class, and keep conformity status, any transition claim and national use permission as separate conclusions.