Annex XVI MDR: Common Specifications, Classes and Deadlines

Introduction

Annex XVI MDR products are regulated more strictly than the medical devices they resemble, and most manufacturers find that out when a notified body rejects the equivalence claim to the medical twin of their own product. A coloured contact lens, a hyaluronic acid filler sold for lip volume, an IPL hair removal handset and a tDCS headband marketed for concentration offer no clinical benefit, so the Regulation takes benefit out of the equation and leaves the risk to be judged on its own.

Since 22 June 2023 the Regulation has applied to these products. It asks for the same EU MDR technical documentation as for any other device, a clinical evaluation under Article 61 that demonstrates performance in place of benefit, and conformity with the common specifications of Implementing Regulation (EU) 2022/2346. Those specifications are mandatory. They are not one acceptable solution among several, which is how common specifications work for ordinary medical devices.

This guide covers the scope of Annex XVI and the part of it that is still outside the Regulation, qualification and classification under MDCG 2023-5, the risk management rules of the common specifications, the label and instructions for use, the six product annexes one by one, clinical evaluation and equivalence under MDCG 2023-6, the transitional provisions, and the findings that recur. The date to keep in view is 1 January 2027, when products on the route without a clinical investigation lose their transitional status unless a notified body agreement is signed.

Table of Contents

• What Annex XVI MDR covers, and the part that remains outside the Regulation
• Qualification under MDCG 2023-5: the description decides
• The characteristics that have to match
• Dual-purpose devices, two groups at once, and accessories
• Products that do not qualify
• Classification: why hair removal is class IIa and a tDCS headband is class III
• Annex I of the common specifications: ISO 14971 with the benefit taken out
• Risk acceptability with nothing to weigh against
• Users, consumers and the lay person presumption
• The order of risk controls, and safety information beyond the IFU
• Information for safety: the label statement, the claims ban and the consumer annex
• The six product annexes, group by group
• Contact lenses (Annex II)
• Implants that modify the anatomy (Annex III)
• Dermal fillers (Annex IV)
• Liposuction, lipolysis and lipoplasty equipment (Annex V)
• Lasers, IPL and other light sources (Annex VI)
• Brain stimulation equipment (Annex VII)
• Clinical evaluation: performance instead of benefit, and no equivalence to the medical twin
• Transitional provisions: the 1 January 2027 gate and the two after it
• The rest of the MDR applies, because the product is now a device
• Six findings that recur in Annex XVI files
• Frequently asked questions
• Conclusions

What Annex XVI MDR covers, and the part that remains outside the Regulation

Recital 12 of Regulation (EU) 2017/745 gives the reason for the whole construction. Some products are sold with an aesthetic or other non-medical claim only, yet they work like medical devices and carry the same kind of risk. A breast implant placed for augmentation ruptures in the same way as one placed for reconstruction. Article 1(2) therefore extends the Regulation to the groups of products listed in Annex XVI, from the date on which common specifications for the group apply.

Three consequences follow from the wording of Article 1. Under Article 1(2), the common specifications have to address at least the application of risk management and, where necessary, clinical evaluation regarding safety, and they have to take account of the state of the art and of harmonised standards for analogous medical devices built on similar technology. Under Article 1(3), a product with both a medical and a non-medical purpose has to meet both sets of requirements cumulatively. Under Article 1(4), products brought into scope this way are called devices, so every provision addressed to devices applies to them unless it says otherwise.

Annex XVI lists six groups: contact lenses and other items introduced into or onto the eye; products introduced into the body by surgically invasive means to modify the anatomy or to fix body parts, other than tattooing products and piercings; substances or items for facial, dermal or mucous membrane filling by injection or other introduction, other than tattooing; equipment to reduce, remove or destroy adipose tissue; high intensity electromagnetic radiation equipment for skin resurfacing, tattoo or hair removal or other skin treatment; and equipment for brain stimulation that applies currents or fields penetrating the cranium to modify neuronal activity. Article 1(5) empowers the Commission to add groups by delegated act.

The common specifications were adopted as Commission Implementing Regulation (EU) 2022/2346, published on 2 December 2022 and applicable from 22 June 2023. They do not cover everything Annex XVI describes. The Commission left out products for which it had no information of marketing in the Union, and products for which the available information was not enough to write specifications. MDCG 2023-5 draws the conclusion in plain terms: where no common specification covers a product, the MDR does not apply to it, and other Union legislation may.

The right-hand column is not a list of exemptions that a manufacturer can enjoy. A product there cannot be CE marked under the MDR for its non-medical purpose at all, and it stays under general product safety law and national rules. The second half of group 2 is the largest gap: the common specifications cover products that modify the anatomy and say nothing about products that fix body parts.

Qualification under MDCG 2023-5: the description decides

MDCG 2023-5, published in December 2023, is the guidance on qualification and classification of Annex XVI products. Its first instruction is about method. Qualification comes before classification, and the definitions of medical device and accessory in Article 2 are not the test. The Regulation gives no definition of an Annex XVI product, so the test is the description of the group in Annex XVI read together with the scope section of the matching annex of the common specifications.

The characteristics that have to match

A product qualifies when it fulfils the characteristics those two texts mention: the type of product, the technology, the way it functions, the body part, organ or tissue it targets, and its intended purpose. The examples given in the legal texts support the analysis without being exhaustive, and similarity to an analogous medical device in functioning and risk profile is a guiding principle taken from Recital 12.

The guidance then fixes the meaning of several terms the Regulation leaves open. Fixation means a firm and stable coupling of two or more body parts with no relative movement between them. Subcutaneous refers to the fatty tissue below the dermis, submucous to the connective tissue beneath the mucosa, and intradermal to the dermis itself. The words about other introduction in group 3 cover prefilled hyaluron pens and prefilled dermarollers. A mesotherapy product is covered only where its intended purpose is, or includes, filling.

The definition with the widest effect is the one for high intensity in group 5. The guidance does not set a threshold in joules or watts. Radiation is high intensity when it can cause the effect on the target tissue that the product needs in order to achieve its intended purpose, whether by thermal or photochemical effects, vaporisation, cavitation, shock waves or dielectric breakdown. Infrared, visible and ultraviolet light are examples in the legal text and not limits, and the guidance names radiofrequency as another type of electromagnetic radiation that can qualify.

The high intensity definition is functional. If a light or radiofrequency device works on the skin as claimed, it is high intensity by definition, and the argument that a low-power device falls below the scope is an argument that the device does not perform.

Dual-purpose devices, two groups at once, and accessories

A device with both a medical and a non-medical purpose has to satisfy the MDR requirements for medical devices and the common specifications together. Where the two sets differ, for example on the acceptability of risk, MDCG 2023-5 says the more stringent requirement applies. A coloured contact lens that also corrects sight is a dual-purpose device that achieves both purposes at once, unless the colour itself has a medical purpose, in which case it is simply a medical device.

Where the two purposes are never achieved in the same person at the same time, the two sets of requirements can be applied separately to the two uses. Risk control measures are the exception, and they have to be assessed in combination. The guidance gives a laser as its example: a wavelength restriction that makes the device safe for a medical skin treatment can harm the skin when the same device is used for hair removal, and an energy limit set for hair removal can undermine the medical performance.

The six groups differ enough that a product normally falls into one of them. Where a product genuinely achieves the purposes of two groups and has the characteristics of both, the specifications for both apply cumulatively. A lipolysis laser that only removes fat belongs to group 4. One that also tightens the skin belongs to groups 4 and 5, and the same reasoning applies to radiofrequency-assisted liposuction.

Accessories have no definition for Annex XVI products. An item is covered only if it matches an Annex XVI description and a scope section of the common specifications in its own right. An item that can be used only with one Annex XVI product can be placed on the market with it and treated as part of it. An item usable on its own or with several products can be marketed either as an Annex XVI product itself or together with the compatible products.

Products that do not qualify

Section 3.6 of the guidance lists products that are not Annex XVI products, in addition to those the legal texts exclude directly. The list is where most borderline disputes in aesthetic medicine are settled.

Falling off this list is not a commercial advantage. An injectable skin booster with a hydration claim is not an Annex XVI product, and without a medical purpose it is not a medical device either, so the MDR offers it no CE marking route. Manufacturers who respond by adding a filling claim bring the product into group 3, where it will be class III if it is resorbed, and where the clinical data have to support the filling performance at each anatomical site claimed.

Classification: why hair removal is class IIa and a tDCS headband is class III

Once a product qualifies, Annex VIII applies to it like any other device. The rules for non-active products work without adjustment. Non-corrective contact lenses are invasive with respect to a body orifice and fall under Rule 5: class IIa for short-term use and class IIb for long-term use. Implants and fillers fall under Rule 8: class IIb as a baseline, and class III where the product is wholly or mainly absorbed, or is a breast implant or a surgical mesh. A filler that contains lidocaine or another substance that would be a medicinal product if used separately is class III under Rule 14, and the notified body has to consult a medicines authority before it can certify.

The active rules do not work, and the reason is in their text. Rules 9 and 10 classify active therapeutic devices and active devices for diagnosis and monitoring. A laser for hair removal and a headset for cognitive enhancement do neither, so they would have dropped to Rule 13 and class I, with no notified body. By letter of 28 July 2022 several Member States asked the Commission to correct this, and Implementing Regulation (EU) 2022/2347, in force since 22 December 2022, reclassifies three groups by derogation from Rule 13.

High intensity radiation equipment for skin treatment is class IIb, unless it is intended for hair removal only, in which case it is class IIa. Equipment to reduce, remove or destroy adipose tissue is class IIb. Brain stimulation equipment is class III. The recitals justify the first two by analogy with medical devices of similar functioning and risk. For brain stimulation the reasoning is different: the fields penetrate the cranium, the changes in neuronal activity can last, and unintended effects may be difficult to reverse.

The examples in MDCG 2023-5 show how far class IIb reaches in group 5. Laser equipment for skin resurfacing, tattoo removal, scars, pigmentation and vascular lesions is class IIb, and so is IPL equipment for skin rejuvenation and LED equipment for skin rejuvenation, hair growth stimulation or acne scars, with LED face masks named as an example. Only equipment for hair removal and nothing else is class IIa. In group 4, the suction pump and the cryolipolysis unit are class IIb, a single-use cannula is class IIa under Rule 6, a reusable cannula is a class I reusable surgical instrument, and connecting tubes are class I under Rule 1.

The class decides the conformity assessment under Article 52. Class III products need a technical documentation assessment for each device, and class III implantable products, which include resorbable fillers and breast implants, fall within the clinical evaluation consultation procedure of Article 54 unless one of its exemptions applies. Class IIb implantable products are also assessed device by device. For non-implantable class IIb equipment the notified body samples at least one representative device per generic device group, and for class IIa at least one per device category. For a dual-purpose device the classification considers both purposes and the stricter result applies.

The Commission proposal of 16 December 2025 to amend the MDR, COM(2025) 1023, would rewrite Rule 9 so that it expressly covers active Annex XVI products intended to administer or exchange energy: class IIa by default, with the higher class kept for energy delivered in a potentially hazardous way. At the time of writing the proposal is still in the ordinary legislative procedure and its text may change. Until an amending regulation is adopted and applies, Implementing Regulation (EU) 2022/2347 is the law, and a classification rationale written against the proposal will be rejected.

Annex I of the common specifications: ISO 14971 with the benefit taken out

Annex I of Implementing Regulation (EU) 2022/2346 applies to every product covered by Annexes II to VII. It lays down a complete risk management process in six steps: planning, hazard identification and risk analysis, risk evaluation, risk control and evaluation of residual risks, review, and production and post-production activities. Recital 10 states that the rules were written to be in line with ISO 14971:2019, so a manufacturer with a working ISO 14971 risk management process already has most of the structure.

Two points of law change how the annex has to be read. Under Article 1(2) of the implementing regulation, the common specifications cover the second sentence of Section 1 and Sections 2 to 5, 8 and 9 of MDR Annex I, and conformity with them gives a presumption of conformity with those sections. The other general safety and performance requirements in Annex I still have to be demonstrated in the usual way. And under Article 9(4) of the MDR, manufacturers of Annex XVI products must comply with the common specifications. The option in Article 9(3) of justifying an equivalent alternative solution is not available to them.

Risk acceptability with nothing to weigh against

Section 9 of MDR Annex I restates the general safety requirements for Annex XVI products. The product, used as intended, must present no risk at all, or a risk no greater than the maximum acceptable risk consistent with a high level of protection for the safety and health of persons. The words about weighing risks against the benefit to the patient, on which an ordinary risk file relies, are absent.

The common specifications turn that into a working criterion. Top management has to define and document a policy for risk acceptability that takes account of the state of the art and of safety concerns expressed by interested parties, and that includes the principle of reducing risks as far as possible without adversely affecting the overall residual risk. Section 3.3 then states when a residual risk may be considered acceptable: the undesirable side-effects are transient, and they do not require medical or surgical intervention to prevent life-threatening illness, permanent impairment of a body function or permanent damage to a body structure. Where a risk does not meet those conditions, the manufacturer has to write a justification for accepting it. The criterion for the overall residual risk, and the method for evaluating it, also have to be defined in the plan.

Two further rules remove options that manufacturers of medical devices rely on. Section 6.4 requires risk control measures to be taken even where they reduce the performance of the device, as long as its main function is maintained. Section 6.5 requires a check that each measure does not create new hazards or raise other risks so that the overall residual risk increases.

Clause 7.4 of ISO 14971, the benefit-risk analysis for a residual risk that fails the acceptability criteria, has no counterpart in the common specifications. A risk file that closes a permanent or intervention-requiring harm by citing the benefit of the treatment has used an argument the Regulation does not allow for these products.

Users, consumers and the lay person presumption

The common specifications introduce a person the MDR does not name. The consumer is the natural person on whom the product is intended to be used, and the user is whoever operates it. The two can be the same person, as with a home hair removal device, or different people, as with a filler.

The risk analysis has to distinguish between user groups. A user may be a healthcare professional or a lay person, and among lay persons the manufacturer separates someone with no qualification from someone who uses the device in a professional activity and has a proven qualification for it, such as a beautician operating an IPL system. Section 4.3 then sets a presumption that shapes the whole analysis: all of these groups are presumed to have access to the device, unless it is sold directly to healthcare professionals only. A statement in the instructions that a device is for professional use does not remove untrained users from the risk analysis. The sales channel does.

Section 2.5 turns this into an output. On the basis of the risk management results, the manufacturer has to define the categories of users and consumers who are excluded from use of the device, or for whom special conditions apply, and that information has to reach the label and the instructions for use. Section 4.2 requires the description of the intended use to cover the body part or tissue, the categories of users and consumers, the use environment and the treatment procedure.

Competence is regulated too. Personnel performing risk management tasks need documented knowledge of and experience with the device, equivalent devices without a medical purpose or analogous devices with one, together with the technology and risk management techniques. An analogous device is defined as the same device with a medical purpose, or a medical device for which equivalence to that device has been demonstrated under Section 3 of MDR Annex XIV.

The order of risk controls, and safety information beyond the IFU

Section 6.2 lists four categories of risk control: inherent safety by design, inherent safety by manufacturing, protective measures in the device or in the manufacturing process, and information for safety with user training where appropriate. The order is binding. A measure from one category may be used only where the measures of the preceding category cannot be implemented or have not brought the risk to an acceptable level, and the file has to show that reasoning for each control.

Information for safety is the last resort, and Section 6.3 widens what it means. It may not be limited to the label and the instructions for use. The manufacturer has to consider information built into the device that the user cannot disregard, public information that the user can reach easily, and training. This is the legal basis for the online instruction videos that Annexes VI and VII require.

The analysis itself has to use clinical data as one of its sources for estimating severity and probability. Where data on probability cannot be generated, because of the nature of the device or for ethical reasons, Section 4.5 requires a risk estimate based on the nature of the harm and a worst-case probability, with the reason for the missing data justified in the technical documentation. Before commercial release, a risk management review has to confirm that the plan was followed, that the overall residual risk is acceptable and that the system for collecting production and post-production information is in place.

Information for safety: the label statement, the claims ban and the consumer annex

Sections 9 to 12 of Annex I of the common specifications add four requirements to the labelling rules of MDR Annex I, Section 23, which continue to apply in full.

The first is about the audience. Safety information has to take into account the different degree of understanding of users and consumers, with particular emphasis on lay persons, and the environment in which the device is used, especially outside a medical or otherwise professionally controlled setting. A set of instructions written for a dermatologist does not meet this requirement when the device is sold to beauty salons.

The second is the claims ban in Section 10. Where a device has a non-medical purpose only, the information supplied with it must not carry any clinical benefit claim or statement. Where it has both purposes, the information provided for the non-medical purpose must not carry one. The ban works in both directions for a manufacturer. A filler leaflet that mentions the correction of lipoatrophy, or a laser brochure that mentions the treatment of acne, has either breached Section 10 or declared a medical purpose that the technical documentation, the clinical evaluation and the classification then have to support.

The third is the label. It has to bear the words ‘non-medical purpose:’ followed by a description of that purpose. Where feasible, the label also states the categories of users and consumers who are excluded or subject to special conditions, the expected performance of the device and the risks arising from its use.

The fourth is the content of the instructions for use. They have to state the excluded and restricted categories of users and consumers; describe the expected performance so that both the user and the consumer understand which non-medical effect to expect; describe the residual risks and their control measures clearly enough for the consumer to make an informed decision on whether to be treated, implanted or to use the device; give the expected lifetime or resorption period and any necessary follow-up; and refer to the harmonised standards and common specifications applied.

Five of the six product annexes then require a separate annex to the instructions for use, written in language commonly understood by lay persons and in a form that is easy to hand over. Where a professional applies the device, the instructions must require that professional to give the consumer a copy before treatment. The table shows what each product annex adds. The wording of the mandatory statements must be copied from the Official Journal in the language of each Member State of sale, and not from a summary such as this one.

The six product annexes, group by group

Annexes II to VII share one structure: a scope section, a list of specific risks that the risk analysis has to consider, a list of specific risk control measures to adopt where relevant to the device, and requirements for the label and the instructions for use. The specific risks are a floor for the hazard analysis, and a file that cannot show where each listed risk was considered is incomplete on its face.

Contact lenses (Annex II)

Annex II is the only product annex written for a device that a lay person buys, fits and wears with no professional involved, and its risk list reflects that. It is organised in three parts. The design and manufacturing part covers the shape of the lens, including edges, dislocation from the cornea, folding and unequal pressure; the choice of raw materials, surface treatments and storage solution with regard to biological safety, oxygen permeability and compatibility; microbiological properties including bioburden, endotoxins and sterility; the primary packaging; and the effect of long-term storage. The biological evaluation of the final product, with its packaging and solution, has to consider at least cytotoxicity, sensitisation, irritation, acute systemic and subacute toxicity, implantation, sterilisation residues, degradation products, and extractables and leachables, and where cumulative contact is expected to exceed 30 days also subchronic and chronic toxicity and genotoxicity.

The second part has no parallel elsewhere in device regulation: the distribution chain. The manufacturer has to analyse the absence of pre-use fitting by an ophthalmologist, optometrist, specialised optician or contact lens specialist, and the lack of expertise of distributors outside the classic optician channel in selecting lenses, storing and transporting them, and advising users. A manufacturer selling cosmetic lenses through costume shops and online marketplaces has to include that channel in the risk file as a source of hazards.

The third part covers the wearer: inexperience, hygiene failures, reduced tear film and oxygen at the cornea, hindered vision, extended wear, continuing to wear lenses on a red or irritated eye, using the blister as a storage case, irregular re-use, and unfamiliarity with what to do when something goes wrong. Non-medical situations in which lenses must not be worn have to be identified, with driving, operating machinery and water activities named.

The control measures are stated as requirements on the product. The field of vision must not be reduced, including when the lens is displaced or badly placed, and enough light has to pass for adequate visibility in all conditions of use. All materials, including the inner side of the packaging and the storage solution, must be biocompatible, and the colourants and prints must not leach under the intended conditions of use. Lenses, packaging interior and solution must be sterile and non-pyrogenic. For multiple-use lenses the manufacturer either supplies care solutions and cleaning means sufficient for the whole lifetime of the lens or specifies them, and validates the maximum number of re-uses and the maximum duration of use. A procedure has to exist by which users identify side-effects and report them to the manufacturer, and the label and instructions have to be understandable to a lay person.

The instructions for use are the longest of any annex. Beyond the items in the table above, they carry prescribed warnings against sharing used lenses, cleaning with tap water, contamination with make-up or aerosols, wearing lenses in traffic, at machinery, in water or during sleep, use in very dry or dusty environments, use after expiry and beyond the maximum wearing time, and re-use of the packaging or the storage solution. They also list the contraindications, which include dry eyes, eye medication, allergies, inflammation or redness, colds and flu, and previous eye interventions, and the symptoms on which the lens must be removed at once, with advice to see an eye care professional if they persist.

Implants that modify the anatomy (Annex III)

Annex III covers non-active products introduced by surgically invasive means to modify the anatomy: subdermal and transdermal implants, gluteal implants, threads, and breast implants where the purpose is not medical. The risk analysis has to contain a dedicated section on the risks of introducing the device surgically for a non-medical purpose, taking into account the characteristics of the people likely to seek and to perform the procedure.

The aspects to analyse include the physical and chemical characteristics and the full composition of the implant; for resorbable devices the resorption profile with the half-life and the end of resorption; the specific anatomical location for which clinical and other data support use; consumer factors such as previous accidents and age restrictions; heating in magnetic resonance imaging; the compatibility of delivery instruments; and the interval between implantations. The biological evaluation list is longer than for lenses and adds material-mediated pyrogenicity and carcinogenicity.

The hazard list runs to 29 entries and covers the complications reported for breast and body implants: rupture and unintended degradation, dislodgement and migration, asymmetry, visibility through the skin, deflation and wrinkling, gel bleed, capsular contracture, haematoma, seroma, infection, wound dehiscence, extrusion, scarring, nerve and vascular damage, compartment syndrome, necrosis, granuloma and siliconoma, over-sized implants, limitation in cancer diagnosis, and breast implant associated anaplastic large cell lymphoma.

Five control measures are prescribed. The device is sterile and non-pyrogenic, or comes with sterilisation instructions if supplied non-sterile. Safe use is supported by clinical and other data that consider the anatomical location. Long-term data are collected on non-degradable substances originating from the device. The presence of the carcinogenic, mutagenic, reprotoxic and endocrine-disrupting substances referred to in Section 10.4.1 of MDR Annex I is evaluated whatever their concentration, which removes the 0.1% threshold that ordinary devices work to. And the manufacturer provides training on implantation and safe use that is accessible to users.

Dermal fillers (Annex IV)

Annex IV applies to substances and items for filling by subcutaneous, submucous or intradermal injection or other introduction, and to syringes and dermarollers only where they are prefilled with such a substance. Many hyaluronic acid fillers were CE marked as medical devices under Directive 93/42/EEC, so for this group the common specifications changed an existing file more than they created a new one.

The aspects to analyse follow the product through the procedure. They include resorption and lifetime in the body, with the possibility of metabolisation, for which the annex gives enzymatic degradation of hyaluronic acid as its example; the specific anatomical location of injection; consumer factors including previous and current treatments, age, pregnancy and breast-feeding; the risks of a local anaesthetic, whether part of the product or used alongside it; and, for non-resorbable products, the risks of removal. A final group of aspects concerns administration: injection technique, the means of injection, the maximum quantity by location and technique, repeated injections, the force needed to administer the product, product temperature, and transfer from a vial to a syringe.

The hazard list shares most entries with Annex III and adds the ones specific to injection: migration, oedema, vascular damage, severe allergic reactions, blindness and necrosis. Blindness after facial injection is a rare event, and the fact that the legislator lists it by name means that a risk file which does not address vascular occlusion by injection site has not met the annex.

The control measures require the product to be sterile, non-pyrogenic and for single use, and repeat the Annex III requirements on clinical data by anatomical location, long-term data on non-degradable substances, evaluation of Section 10.4.1 substances regardless of concentration, and training. The anatomical location requirement has a direct effect on claims. Clinical data on nasolabial folds do not support a claim for lips, tear troughs or body contouring, and each claimed site needs its own evidence.

The instructions for use have to give precise technical information for good administering practice; describe the treatment of the most common side-effects, with overdosing, swelling, hardening, nodules and immune responses named; explain how and when new injections can be placed at previously injected sites; and list the constituents. For the constituents responsible for the intended action, the list gives the concentration and, where applicable, the molecular weight range, the particle size and the degree of cross-linking, with the method used to determine it. Cross-linking agents, solvents, anaesthetics and preservatives are listed with their concentrations. The consumer annex has to declare the presence of Section 10.4.1 substances, heavy metals or other contaminants, and includes a part in which the healthcare professional records the location, number and volume of injections for each consumer.

Liposuction, lipolysis and lipoplasty equipment (Annex V)

Annex V defines its three terms. Liposuction is the surgical removal of localised subcutaneous fat deposits by aspiration, lipolysis is the localised destruction of fat deposits, and lipoplasty is the modification of body contours by removal of excess fat. The recitals of the reclassification regulation show how wide lipolysis is meant to be: radiofrequency, ultrasound, cryolipolysis, laser, infrared, electrical stimulation and acoustic shockwave equipment are all named.

The aspects to analyse include the volume of tissue removed or destroyed and the metabolic effect of the released tissue components; the minimum interval between procedures; the anatomical location; the cannula type and the suction applied; the infiltration fluid and the type of anaesthetic; whether the device works by suction alone or adds laser or ultrasound energy; and the age, gender and body mass index of the population in which the clinical data were obtained. General hazards include seroma, organ perforation and bleeding, thermal and mechanical injury, and interference with active implants and metallic objects. For liposuction the annex adds haemorrhage, perforation of the abdominal viscera, thorax or peritoneum, pulmonary embolism, severe bacterial infection, hypovolaemic shock, seizures and lidocaine toxicity in tumescent procedures. For lipolysis it adds burns, over-exposure, neurovascular injury, collagen remodelling and deformity that requires medical intervention.

The control measures are technical. Lipolysis devices need controls for application time, waveform, energy applied and the temperature reached on or in the body, with simultaneous visual and audible automatic alarms when a critical value is reached for one parameter or for a combination. Where applicable, devices need a low-energy preset, an emergency stop and automatic deactivation on over-exposure or excessive liposuction. Invasive parts are sterile and pyrogen-free, and the manufacturer trains users.

Section 5.5 is the provision with the largest market effect in this annex: none of the three device types may be used by a lay person in a private setting. A consumer body-contouring device whose intended purpose is to destroy adipose tissue has no compliant configuration.

The instructions for use carry prescribed lists. The contraindications include coagulation disorders and anticoagulant treatment, uncontrolled hypertension, diabetes mellitus, cancer, a body mass index above 40, pregnancy, surgery within the previous six weeks, skin infections, varicose veins in the treatment area, heart, lung or circulatory disease, age under 18 and fever, with metallic objects and active implantable or body-worn devices added for radiofrequency and electromagnetic field equipment. The adverse effects include hypovolaemia and hypervolaemia, bradycardia, venous thromboembolism, fat embolism, infection and contour irregularities. Prescribed warnings state that these procedures are not reliable methods of weight reduction and are not validated for clinically diagnosed obesity, and, for invasive use, that the procedure takes place in an appropriate medical environment, performed by a trained medical doctor assisted by at least one other doctor or allied health professional, with staff trained in life support and with monitoring during and after the procedure.

Lasers, IPL and other light sources (Annex VI)

Annex VI applies to high intensity radiation equipment for skin resurfacing, which it extends to skin rejuvenation; tattoo removal, which it extends to permanent make-up; hair removal; and other skin treatment, which includes the non-medical treatment of port-wine stains, haemangioma, telangiectasia, pigmented areas and scars that are not an injury in the sense of the medical device definition. It then defines two categories. A device for professional use is used in a healthcare or otherwise controlled professional environment by professionals with proven qualification. A device for home use is used in private environments by lay persons.

The risk analysis has to consider skin type and degree of tanning, skin abnormalities and disease, the age of the consumer, concurrent medical treatment, photosensitising medicines and cosmetics, anaesthesia that dulls the reaction to harm, and exposure to other light sources. The 25 listed risks include burns, scars and keloids, hypopigmentation and hyperpigmentation, accelerated skin ageing, reactions to tattoo pigments, formation of skin cancers, alteration of existing skin cancers and nevi with delayed diagnosis of disease such as melanoma, eye damage to the retina and cornea, paradoxical hypertrichosis, unintended release of radiation, and ignition, explosion or fumes.

Two rows of this table decide product strategy. Home use is limited to hair removal, and MDCG 2023-5 places LED equipment for skin rejuvenation, including LED face masks, among the class IIb examples of group 5. Read together, a home-use light device for rejuvenation that meets the functional definition of high intensity cannot comply with Section 5.3, whatever its class. For hair removal devices, Section 5.1 also requires ultraviolet emission to be minimised, for instance with a band edge filter.

The instructions for use have to quantify the treatment. They state the minimum radiation intensity, duration and frequency of use needed to trigger the effect; the maximum and recommended values; the minimum interval between applications at the same location; the level at which risks rise sharply, if there is one; the level beyond which no further performance is gained; the pulse energy, fluence, wavelength range, pulse duration and pulse profile; the maximum spot size, the minimum homogeneity of the spot and the rules for overlap; the expected lifetime and stability of performance; and the cosmetics, medicines and other radiation sources that interact with treatment.

Except for hair removal where excessive hair is not attributed to a medical condition, the manufacturer has to advise users and consumers that a medical consultation with a diagnostic examination of the skin areas should take place first, and advise users not to treat before they have the documentation of it. For professional devices the instructions require a measurement of light energy density at least annually and recommend an annual electrical safety test, describe safety precautions such as non-reflective instruments and room ventilation, and call for a warning notice outside the procedure room. The device must not be used on skin with an increased likelihood of skin cancer, or on open wounds, rashes and inflamed or infected areas.

Brain stimulation equipment (Annex VII)

Annex VII covers non-invasive equipment for transcranial alternating current, direct current, magnetic and random noise stimulation. It is class III, and the annex explains why the legislator was cautious. The risk analysis has to take special care over electrode placement and over the strength, waveform and duration of the current or field. Incorrect placement can cause failed performance, enhanced currents in tissue or unintended neural responses. Neural responses differ between groups of people, and the annex names those it considers particularly vulnerable, among them persons under 18, young adults, pregnant women, psychiatric patients and people with conditions affecting the central nervous system. Excessive, frequent or cumulative long-term use may produce unforeseen neural effects, which the annex says might in some cases include structural changes in the brain.

The listed hazards include psychological, neural and neurotoxicity risks; cognitive side-effects in the short, medium and long term, including compensatory trade-offs in regions that are not stimulated; transient hearing threshold shift and tinnitus; hazards at the interface between electrode and skin; use in highly stimulating or attention-demanding environments; interference with or injury from active implants, body-worn devices and metallic implants; use after alcohol, drugs or stimulant medicines; and the potentiating effect of several devices used at once.

Section 4.1 sets a default exclusion list. Unless the manufacturer has specific evidence of safe use, nine categories of consumer are excluded: persons with a history of epilepsy; persons on medicines for conditions of the central nervous system; persons under treatment that changes central nervous system excitability; users of illicit or perception-modifying substances; persons with a tumour of the central nervous system; persons with vascular, traumatic, infectious or metabolic brain lesions or disease; persons with sleep disorders, drug dependency or alcoholism; persons under 18; and pregnant women. The instructions for use have to state that the device is not to be used on or by them.

The device needs controls for application time, waveform and energy, and automatic alarms when a critical value is reached for one parameter or a combination, with the critical values set below the maximum acceptable values. Where relevant, the manufacturer applies access control, minimisation of stray magnetic fields, an emergency stop, automatic deactivation at maximum output, at maximum duration or at a combination of both, signals for standby, operation and loss of full skin contact, training, and instruction videos on the internet.

The information requirements address a product whose effect a consumer cannot verify. The instructions and, if possible, the label describe the performance the consumer can expect in terms that make the non-medical effect understandable; the annex itself gives enhanced intelligence and improved mathematical ability as examples of such effects. The instructions show how electrodes and coils are placed on the head, explain the consequences of wrong placement, state the duration, intensity and frequency of stimulation, the energy delivered, the brain area targeted, the waveforms and pulse characteristics, and list the direct and indirect risks of interaction with metallic and active implants, including current conduction, heating and displacement of metal objects.

Clinical evaluation: performance instead of benefit, and no equivalence to the medical twin

Article 61(9) of the MDR adapts clinical evaluation to these products in three steps. The requirement to demonstrate a clinical benefit is to be understood as a requirement to demonstrate the performance of the device. The evaluation is based on relevant data concerning safety, including post-market surveillance data, post-market clinical follow-up and, where applicable, a specific clinical investigation. And clinical investigations are to be performed unless reliance on existing clinical data from an analogous medical device is duly justified.

That last clause appears to allow an alternative, and Recital 11 of the common specifications removes most of it. The recital starts from the position that a medical device and a non-medical product cannot, as a rule, be shown to be equivalent, and concludes that where the only investigation results available concern medical devices, investigations should be carried out on the non-medical product. MDCG 2023-6, published with MDCG 2023-5 in December 2023 and available on the Commission's page of MDCG endorsed guidance, explains the mechanics. It is to be read together with MDCG 2020-5 on equivalence.

The practical reading is that equivalence to the medical version of the same technology is closed, and that Article 61(9) has to be planned for as a requirement to hold clinical data on the product itself. Data from the analogous medical device keep a role outside equivalence: they inform the state of the art, check that the hazard analysis is comprehensive and help to define the scope of the clinical evaluation. The same holds in the other direction, since MDCG 2020-5 states that a medical device cannot claim equivalence to an Annex XVI product.

For products that were lawfully on the market before June 2023, clinical data on the product itself often already exist. Complaint and vigilance records, post-market studies, registries and published literature on the device are clinical data within the meaning of the MDR, and a manufacturer whose data are sufficient can take the transitional route without a clinical investigation. Whether they are sufficient is a question the notified body will ask per claimed purpose and, for implants and fillers, per anatomical location, because Annexes III and IV make location a risk control measure.

Performance has to be demonstrated with the same discipline as safety. The instructions for use must describe the non-medical effect the consumer can expect, and that description is a claim. Hair reduction after a defined number of sessions, the duration of a volume effect, or a change in a cognitive measure each need an endpoint, a measurement method and data. For a class III or implantable product the general rule of Article 61(4) on clinical investigations applies alongside Article 61(9), and a summary of safety and clinical performance under Article 32 is required. The common specifications assume as much, since they list that summary and the post-market clinical follow-up among the sources of post-production information.

Long-term data are a separate obligation for implants and fillers. The manufacturer has to collect data on non-degradable substances originating from the device, which in practice means a post-market clinical follow-up plan with follow-up periods that match the persistence of the material and not the length of the pre-market study.

Transitional provisions: the 1 January 2027 gate and the two after it

Article 1(2) of the MDR gave manufacturers six months between the entry into force of the common specifications and their application. For products that need a notified body, six months was never going to be enough, so Article 2 of Implementing Regulation (EU) 2022/2346 set its own transitional routes. Implementing Regulation (EU) 2023/1194 then extended them, to align with the extension of the MDR transition deadlines by Regulation (EU) 2023/607. The Commission published a question and answer document on the result in September 2023.

Every route rests on the same two conditions. The product was lawfully marketed in the Union before 22 June 2023 and continues to comply with the Union and national law that applied to it before that date, and there has been no significant change in its design or intended purpose. A product launched after that date, or changed significantly since, needs an MDR certificate before it is placed on the market.

The gates on the investigation route have passed. A manufacturer who did not have a complete investigation application confirmed by 22 June 2024, and an investigation under way by 23 December 2024, is on the route of Article 2(2) or on no route at all. For that group the date that matters now is 1 January 2027. From that day a product may be placed on the market only if the manufacturer and a notified body have signed a written agreement for the conformity assessment, and the agreement meant is the contract of Section 4.3 of MDR Annex VII, which follows a formal application. The application therefore has to be lodged well before the date.

Products covered by a Directive certificate that was still valid on or after 20 March 2023 do not use Article 2 at all. They follow Article 120 of the MDR directly, with its end dates of 31 December 2027 and 31 December 2028. For a dual-purpose device, Article 120 governs the medical purpose and the common specifications govern the non-medical one, and where the end dates differ the Commission's answer is that the stricter one applies.

Three practical points come from the same document. A product that incorporates a medicinal substance gets no extra time: the 210 days allowed for the medicines authority consultation run inside the transitional period. A manufacturer demonstrates transitional status with a self-declaration that identifies the products, confirms the conditions and states the end date, updated each time a new condition applies, and once the agreement gate is reached a confirmation letter from the notified body can support it. And there is no sell-off limit: a product placed on the market during the transitional period can continue to be made available after it ends.

The rest of the MDR applies, because the product is now a device

The common specifications are written about risk management and information for safety, and it is easy to read them as the whole of the obligation. They are the additional part. Because Article 1(4) makes these products devices, the manufacturer of an IPL handset or a cosmetic lens carries every general obligation of Article 10.

That means a quality management system under Article 10(9), which in practice is built to ISO 13485 and has to exist before a notified body will sign an agreement; a person responsible for regulatory compliance under Article 15; financial coverage for liability under Article 10(16); technical documentation under Annexes II and III; a declaration of conformity and CE marking with the notified body number; UDI assignment under Article 27; and registration of the manufacturer and the devices in EUDAMED. A manufacturer outside the Union needs an authorised representative, and the importers and distributors in the chain take on the verification duties of Articles 13 and 14. For beauty wholesalers and online sellers that have never handled a medical device, those duties are new.

Implantable products add two documents. Article 18 requires an implant card and patient information for implantable devices, and its list of exempted devices contains neither body implants nor fillers. The injection record in the consumer annex of a filler is a requirement of the common specifications and does not replace the implant card.

After certification the post-market system is the ordinary one: a post-market surveillance plan, a periodic safety update report under Article 86, updated at least annually for class IIb and class III and at least every two years for class IIa, vigilance reporting of serious incidents, and trend reporting. The common specifications tie this system back to the risk file. Post-production information that shows a new hazard, a risk that is no longer acceptable or an overall residual risk that is no longer acceptable has to trigger an update of the risk management results and a decision on devices already on the market, and anything that affects the suitability of the risk management process itself goes to top management review.

Six findings that recur in Annex XVI files

The deficiencies raised on these files have a common origin. The manufacturer, or the consultant, has taken a medical device file and changed the intended purpose, and the logic of the medical file has stayed in place underneath.

The equivalence claim to the medical twin is the most expensive, because it is usually discovered at the clinical evaluation assessment, after the application fee has been paid and with a transitional gate approaching. The benefit-risk argument left in the risk file comes next: it is found in the acceptability policy, in the residual risk conclusions and in the risk management report, and each of them has to be rewritten against Section 3.3 of Annex I of the common specifications. The home-use finding is one of design and cannot be closed with a document. A device that emits outside 400 nm to 1,200 nm, has no skin tone sensor or is sold for rejuvenation is a professional device or a non-compliant one.

The three medium findings are quick to fix and are raised often. The label statement of the non-medical purpose is missing or has been translated loosely. The consumer annex does not exist as a separate hand-over document, or exists and contains clinical benefit language copied from the brochure. And the manufacturer cannot produce the self-declaration that shows which transitional route each product is on, which is the first document a competent authority or a distributor will ask for from 1 January 2027.

Frequently asked questions

What is Annex XVI of the MDR?

Annex XVI of Regulation (EU) 2017/745 is a list of six groups of products without an intended medical purpose that the Regulation covers because they function like medical devices and carry similar risks. Under Article 1(2), the MDR applies to a group from the date common specifications for it apply. Those were adopted as Implementing Regulation (EU) 2022/2346 and have applied since 22 June 2023.

Which products fall under Annex XVI MDR?

Non-corrective contact lenses, implants that modify the anatomy such as breast and gluteal implants and threads, dermal fillers, equipment for liposuction, lipolysis and lipoplasty, lasers, IPL and other high intensity light equipment for hair removal, tattoo removal and skin treatment, and non-invasive brain stimulation equipment. Products outside the scope sections of the common specifications, such as sunbeds, products for the fixation of body parts and invasive brain stimulation devices, are outside the MDR.

Do Annex XVI products need a notified body?

Almost all of them do. Contact lenses are class IIa or IIb, implants and fillers class IIb or III, and Implementing Regulation (EU) 2022/2347 reclassified the active products: class IIa for hair removal only, class IIb for other skin treatment and for adipose tissue equipment, and class III for brain stimulation. Only a few items, such as connecting tubes for liposuction, are class I.

Are the common specifications of Regulation (EU) 2022/2346 mandatory?

Yes. Article 9(4) of the MDR requires manufacturers of Annex XVI products to comply with the relevant common specifications. The alternative available for ordinary medical devices under Article 9(3), a justified solution of at least equivalent safety and performance, does not apply. Conformity gives a presumption of conformity with the second sentence of Section 1 and Sections 2 to 5, 8 and 9 of MDR Annex I.

Can an Annex XVI product claim equivalence to a medical device?

No. MDCG 2023-6 explains that equivalence with an analogous medical device cannot be completed, because clinical characteristics such as severity and stage of disease are not defined for a product without a medical purpose. Equivalence can be demonstrated with another product without a medical purpose, or with a dual-purpose device on the characteristics of its non-medical purpose. Data from medical devices remain useful for the state of the art.

What must the label of an Annex XVI product say?

The label must carry the words non-medical purpose followed by a description of that purpose, and where feasible the excluded categories of users and consumers, the expected performance and the risks. Nothing supplied with the device may carry a clinical benefit claim. Implants and fillers also need a prominent statement restricting use to qualified professionals and an indication that they are not for persons under 18.

When do the Annex XVI transitional provisions end?

On 31 December 2028 for products that need a notified body where no clinical investigation is performed, with a written notified body agreement required from 1 January 2027. On 31 December 2029 where a clinical investigation is performed, with the agreement required from 1 January 2028. Products with expired Directive certificates follow the Article 120 dates of 31 December 2027 or 2028. Class I products have had to comply since 22 June 2023.

Can laser or IPL devices be sold for home use under Annex XVI?

Only for hair removal. Annex VI of the common specifications limits home-use devices to hair removal and to wavelengths between 400 nm and 1,200 nm, and requires exposure limits with automatic deactivation, a full skin contact interlock, an integrated skin tone sensor and instruction videos on the internet. Home-use devices for hair removal only are class IIa and need a notified body certificate.

Conclusions

The useful way to approach an Annex XVI product is to treat it as a medical device from which one argument has been removed. The quality system, the technical file, the clinical evaluation, the notified body and the post-market system are all there. What is missing is the benefit that makes a serious residual risk acceptable, and the common specifications fill the gap with a rule: side-effects should be transient and should not need medical intervention, and anything beyond that needs a written justification that will be read sceptically.

Three decisions follow for a manufacturer. Check the scope section of the product annex before anything else, because a product outside it cannot be CE marked for a non-medical purpose and a product inside it may need a design change, as home-use light devices show. Plan the clinical evaluation on data from the product itself. And settle the transitional route in writing now, because the notified body agreement for products without a clinical investigation is due before 1 January 2027 and an agreement is the end of an application process, not the start of one.

Most of the file depends on the risk management, since the common specifications are a risk management text first. The Risk Management Documentation Kit on MD Regulatory includes the Risk Management Plan, the Risk Management Report, the Hazard Analysis, the design and use-related FMEAs and the GSPR checklist — all aligned with ISO 14971 and MDR Annex I, and immediately deployable in an existing ISO 13485 quality management system.

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