MDR Annex XVI: Aesthetic Products Regulated Without a Medical Purpose
A regulation that captures products making no medical claim at all
Most manufacturers meet the Medical Device Regulation because their product does something medical. A smaller group meets it for the opposite reason: the product does nothing medical, and the EU regulates it anyway. That group is defined by Annex XVI to Regulation (EU) 2017/745, and it is where the aesthetic-device industry now lives.
The hook is Article 1(2): "This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology." Two things follow from that sentence. Annex XVI products became devices only when their Common Specifications started to apply, not on the general date of application of the MDR. And the benchmark for what "safe enough" means is borrowed from the medical device that works the same way.
Article 1(4) then folds them into the same vocabulary as everything else: medical devices, accessories and Annex XVI products are all called "devices" for the purposes of the Regulation. There is no separate, lighter regime. A hair-removal laser sold purely for cosmetics carries the same architecture of obligations as a surgical laser.
The six groups, and what the list actually says
Annex XVI is short and closed. It lists six groups of products without an intended medical purpose:
Contact lenses or other items intended to be introduced into or onto the eye — coloured and patterned lenses with no corrective function.
Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts, with the explicit exception of tattooing products and piercings — gluteal and pectoral implants, subdermal implants, lifting threads.
Substances, combinations of substances or items for facial or other dermal or mucous membrane filling by injection or other introduction, excluding tattooing — the dermal filler category.
Equipment to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
High intensity electromagnetic radiation emitting equipment for use on the human body, including lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
Equipment for brain stimulation applying electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity.
The list is descriptive, not definitional. MDCG 2023-5 makes the point that Annex XVI products have no definition in Article 2 at all, so the definitions of "medical device" and "accessory" must not be used to qualify them. You read the wording of the group, and the scope section of the matching Common Specifications annex, and you decide whether your product is described there.
Nothing happened until the Common Specifications arrived
Commission Implementing Regulation (EU) 2022/2346 laid down the Common Specifications for all six groups and applied from 22 June 2023. Annex I of that Regulation carries requirements common to every group — risk management, qualification of the personnel doing it, top-level management responsibility for risk acceptability criteria. Annexes II to VII carry group-specific requirements.
Compliance with them is not optional in the way it is for medical devices. Article 9(3) MDR lets a manufacturer depart from a Common Specification with an equivalent solution; Article 9(4) then removes that freedom: "Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products." For this sector, the Common Specifications are the requirement, not a presumption route.
Commission Implementing Regulation (EU) 2023/1194 amended the transitional article of 2022/2346 and pushed the run-off dates out substantially. Products lawfully marketed in the Union before 22 June 2023, unchanged in design and intended purpose, may continue where the manufacturer is not pursuing a clinical investigation until 31 December 2028, provided a written conformity assessment agreement with a notified body was signed from 1 January 2027. Where a clinical investigation is being performed, the outer date is 31 December 2029, with the investigation required to have started from 23 December 2024 and a signed notified body agreement required from 1 January 2028. Products never marketed in the Union before 22 June 2023 get no transition at all — they need conformity before first supply.
Risk classes: Implementing Regulation (EU) 2022/2347
Annex XVI products are classified under the ordinary Annex VIII rules, with one deliberate override. Commission Implementing Regulation (EU) 2022/2347 reclassified three groups of active products upward, by way of derogation from Section 6.5 of Annex VIII. Its first point reads: "high intensity electromagnetic radiation emitting equipment as referred to in Section 5 of Annex XVI to Regulation (EU) 2017/745 that is intended for the use on the human body for skin treatment is reclassified as class IIb, unless it is intended for hair removal only in which case it is reclassified as class IIa".
Annex XVI group | Typical class | Basis |
Non-corrective coloured or patterned contact lenses | IIa short-term, IIb long-term | Annex VIII Rule 5 |
Surgically invasive products modifying anatomy (gluteal implants, threads) | IIb, III if absorbable or a breast implant | Annex VIII Rule 8 |
Dermal fillers | IIb permanent, III if resorbable, biologically active or containing an ancillary medicinal substance | Annex VIII Rules 8 and 14 |
Liposuction, lipolysis and lipoplasty equipment | IIb | Reg. (EU) 2022/2347 Art. 1(b) |
IPL and laser equipment for skin treatment | IIb, IIa if hair removal only | Reg. (EU) 2022/2347 Art. 1(a) |
Transcranial brain stimulation equipment | III | Reg. (EU) 2022/2347 Art. 1(c) |
Read that table alongside the general classification rules under the MDR. The practical consequence is the same in every row: none of these is Class I. Every one of them needs a notified body, and for many exporters that is the first notified body engagement in the company's history.
Clinical evidence, without a clinical benefit
An aesthetic product has no patient benefit to weigh risk against, so Article 61(9) rewrites the test: "In the case of the products without an intended medical purpose listed in Annex XVI, the requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV shall be understood as a requirement to demonstrate the performance of the device." Clinical investigations are required for these products unless reliance on existing clinical data from an analogous medical device is duly justified.
Annex I is adjusted to match. Section 9 of Chapter I provides that "For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons." This is a stricter formulation than the ordinary benefit-risk test, and it is the sentence most often skipped when an aesthetic manufacturer reuses a risk file written for a general consumer appliance.
Duties the Common Specifications place on the consumer relationship
Because the end user is frequently a beautician or a consumer rather than a clinician, 2022/2346 writes obligations directly into how the product may be used and sold. Section 5.5 of its Annex V states plainly: "Liposuction devices, lipolysis devices and lipoplasty devices shall not be used in private environments by lay persons." Annex VI requires that devices intended to deliver a permanent change of the appearance are not used on persons under 18 years old, and requires professional-use devices to carry an annex to the instructions for use written in language a consumer can understand and designed to be handed to that consumer.
These are design and labelling requirements, not marketing suggestions. A distributor network built around home-use sales of an Annex XVI device can be non-compliant on the business model alone.
The economic-operator chain applies in full
Once Article 1(2) bites, everything else in the Regulation follows. A manufacturer established outside the Union must designate a sole authorised representative under Article 11 before the product may be placed on the Union market, must register in EUDAMED and obtain an SRN, must assign UDIs and must operate post-market surveillance and vigilance. Medex acts as the EU Authorised Representative for this category as it does for any other, under EUDAMED SRN TR-AR-000057550.
Where exporters most often stall
Three patterns recur with aesthetic-device manufacturers in Asia and elsewhere. The first is a company with years of sales into the Union under a low-voltage or EMC declaration, discovering that the CE marking it already applies is the wrong CE marking. The second is a technical file with excellent electrical safety testing and no risk management file that satisfies Annex I of 2022/2346. The third is the absence of clinical data of any kind, combined with the assumption that a cosmetic claim removes the need for it — Article 61(9) says otherwise.
None of that is solved by paperwork alone, and it should not be sold as if it were. Medex does not perform conformity assessment and does not write clients' technical documentation; the notified body route and the evidence behind it belong to the manufacturer. What we can tell you early, before money is spent, is which Annex XVI group your product sits in, what class that implies, and what the transitional dates mean for your specific launch plan. Published annual fees by class are on our pricing page.
Frequently asked questions
Does a hair-removal IPL device sold for cosmetic use only need CE marking under the MDR?
Yes. Since 22 June 2023, when Commission Implementing Regulation (EU) 2022/2346 began to apply, high intensity electromagnetic radiation emitting equipment for skin treatment falls under Annex XVI to the MDR even with no medical claim. Equipment intended for hair removal only is Class IIa; other skin treatment equipment is Class IIb. Either way a notified body is involved.
Do Annex XVI products need clinical data if they have no medical benefit?
Yes. Article 61(9) MDR converts the requirement to demonstrate clinical benefit into a requirement to demonstrate performance. Clinical investigations must be performed for Annex XVI products unless reliance on existing clinical data from an analogous medical device with a medical purpose is duly justified.
Can a manufacturer of an Annex XVI product depart from the Common Specifications?
No. Article 9(3) MDR normally allows an equivalent alternative solution, but Article 9(4) removes that option for Annex XVI products: manufacturers of products listed in Annex XVI must comply with the relevant Common Specifications.
What are the current transitional deadlines under Regulation (EU) 2022/2346 as amended?
For products lawfully marketed in the Union before 22 June 2023 with no significant design or intended purpose change: 31 December 2028 where no clinical investigation is intended, with a signed notified body agreement needed from 1 January 2027; and 31 December 2029 where a clinical investigation is being performed, with the investigation started from 23 December 2024 and a signed notified body agreement from 1 January 2028.
Does a non-EU manufacturer of a dermal filler need an EU Authorised Representative?
Yes. Annex XVI products are devices for the purposes of the MDR, so Article 11 applies without modification. A manufacturer not established in a Member State must designate a sole EU Authorised Representative before the product is placed on the Union market, and must register in EUDAMED.
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