EU Authorized Representative for Dermal Filler Manufacturers: Class III, Annex XVI and the Article 11 Mandate

Two routes into the MDR: medical fillers and Annex XVI fillers

Article 1(2) of the MDR extends the Regulation to groups of products without an intended medical purpose, but only from the date of application of the common specifications written for them. Section 3 of Annex XVI names the filler group in these terms:

"3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing." (MDR Annex XVI, Section 3)

The common specifications are Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022. Article 3 of that Regulation states that it "shall apply from 22 June 2023", and its Annex IV is the product-specific annex for this group, with a scope clause that repeats the Annex XVI wording. From that date, an aesthetic filler is a "device" for the purposes of the MDR and must satisfy both the general requirements of Annex I and the specific requirements of Annex IV. MDR Article 9(4) removes the usual flexibility of common specifications for these products:

"Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products." (MDR Article 9(4))

Many fillers are marketed for both purposes, for example a hyaluronic acid gel for facial volume that is also indicated for HIV-associated lipoatrophy. Article 1(3) settles that case:

"Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose." (MDR Article 1(3))

A second implementing act adopted the same day, Implementing Regulation (EU) 2022/2347, reclassifies certain active Annex XVI products. Its Article 1 covers only equipment for skin treatment by high-intensity electromagnetic radiation, fat reduction equipment and brain stimulation equipment (Annex XVI Sections 5, 4 and 6). It does not touch fillers. Fillers, whether medical or aesthetic, are classified under the ordinary rules of MDR Annex VIII.

Classification: implantable by definition, absorbed in most cases

A filler is injected and stays in place. The MDR definition of an implantable device expressly covers products that are later absorbed:

"‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure." (MDR Article 2(5))

The Commission's Manual on borderline and classification (version 5, April 2026) records the agreed position that injection is a clinical intervention, so fillers meet this definition, and that fillers which are wholly or mainly absorbed fall under Rules 7 and 8 depending on the intended duration of use. Rule 8 is the usual route:

"Rule 8 All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:" (MDR Annex VIII, Rule 8)

"— have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;" (MDR Annex VIII, Rule 8, third indent)

Rule 7 gives the same result for short-term surgically invasive devices that are absorbed. Two further rules frequently apply on top. Fillers containing lidocaine or another anaesthetic fall under Rule 14:

"Rule 14 All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III." (MDR Annex VIII, Rule 14)

Fillers made from animal-derived collagen or hyaluronic acid of animal origin fall under Rule 18, and MDCG 2021-24 Rev.1 lists "Collagen dermal fillers" among its class III examples. Where more than one rule applies, Section 3.5 of Annex VIII requires the strictest.

Product variants and their class

The table reflects the rule wording and the Commission guidance; the final class of any filler depends on its own intended purpose, composition and degradation data as set out in the technical documentation.

Clinical evidence and the common specifications

For class III and implantable devices, Article 61(4) requires clinical investigations unless the narrow exemptions in that paragraph apply. For Annex XVI products the MDR reframes clinical benefit as performance, and sets a high bar for relying on medical device data:

"Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified." (MDR Article 61(9))

Every implantable and class III filler also needs a summary of safety and clinical performance under Article 32, validated by the notified body and published in EUDAMED. Annex IV of Implementing Regulation (EU) 2022/2346 adds filler-specific risk and information requirements, which the notified body will assess alongside Annex I.

For products that were already lawfully on the market before 22 June 2023, Article 2 of Implementing Regulation (EU) 2022/2346, as amended by Implementing Regulation (EU) 2023/1194, sets transitional periods running to 31 December 2028 for products that need no clinical investigation and to 31 December 2029 for products that do. Each period is conditional on dated steps, including a written agreement with a notified body. A new aesthetic filler has no transitional period and needs a certificate before it is placed on the market.

Pitfalls around intended purpose

Aesthetic wording does not reduce the class. The Annex XVI route changes the evidence framework, not the classification rules. An aesthetic-only filler that is absorbed is class III in the same way as a medical one.

Adding an indication adds obligations. A single indication for scar correction or lipoatrophy brings the product within Article 1(3), and the technical documentation must then meet both sets of requirements.

Claims must match the certificate. Article 7 prohibits labelling and promotion that ascribe to a device properties it does not have or suggest uses outside the intended purpose assessed. Longevity, "natural collagen stimulation" and similar statements are claims that need data.

Private labels change the manufacturer. Under Article 16(1), a distributor or importer that sells a filler under its own name assumes the manufacturer's obligations unless the original manufacturer is identified on the label and remains responsible. A non-EU brand owner in that position needs its own mandate.

What Medex does under the mandate

Article 11(1) is the starting point for every non-EU filler manufacturer:

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))

Medex Kurumsal Danışmanlık acts as authorised representative under EUDAMED SRN TR-AR-000057550. Under the mandate we verify that the EU declaration of conformity, technical documentation and notified body certificate are in place, keep copies at the disposal of competent authorities, complete our own actor registration and check your UDI and device registrations, forward authority requests and cooperate on corrective actions, and pass on incident reports without delay. For class III fillers we review the SSCP and certificate scope before we register the devices. A person responsible for regulatory compliance is available in-house, as Article 15(6) requires of every authorised representative.

Because the European Commission's Notice of March 2022 confirms that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey", one Medex mandate covers both markets. Offices in Ankara, İstanbul and Gdańsk.

Annual fees range from €800 for class I to €2,000 for class III, with a €0 setup fee and €150 for a change of representative. We do not write technical documentation or clinical evaluations, we are not a notified body, and we do not find distributors or act as a Swiss or UK representative. We reply within one business day.

Related device categories and country pages

We keep separate pages for other device groups, including reusable surgical instruments, examination and surgical gloves and condoms. All groups are listed on the medical device categories page. Most of the manufacturers we represent are based in China, Türkiye, India and South Korea; the full list is on the EU authorized representative by country page. We also cover dental implants, materials and custom-made devices.

To check how Annex VIII applies to your own device, use our free MDR classification checker. It walks through rules 1 to 22 and quotes the rule text behind every result.

If your device is still placed on the market under an MDD, AIMDD or IVDD certificate or declaration, the free MDR and IVDR transition deadline checker shows the Article 120 or Article 110 date that applies and the conditions it depends on.

Frequently asked questions

Our filler is sold for cosmetic use only. Does it still need an EU authorised representative?

Yes. Since 22 June 2023 an aesthetic filler listed in Annex XVI, Section 3 is a "device" for the purposes of the MDR, and Article 11(1) applies to every device whose manufacturer is not established in a Member State.

Can a resorbable hyaluronic acid filler be class IIb?

Not under the current wording. Rule 8 classifies implantable devices that are wholly or mainly absorbed as class III, and the Commission's borderline manual confirms that injected fillers are implantable devices.

Does Implementing Regulation (EU) 2022/2347 reclassify dermal fillers?

No. Its Article 1 reclassifies only certain active Annex XVI products: skin treatment equipment using high-intensity electromagnetic radiation, fat reduction equipment and brain stimulation equipment. Fillers follow Annex VIII.

Does one mandate cover the European Union and Türkiye?

Yes. Under the EU–Türkiye Customs Union arrangement described in the Commission Notice of March 2022, a manufacturer outside both needs one authorised representative, established either in the EU or in Türkiye.

Sources

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

Commission Implementing Regulation (EU) 2022/2346 (common specifications for Annex XVI products) — eur-lex.europa.eu

Commission Implementing Regulation (EU) 2022/2347 (reclassification of certain active Annex XVI products) — eur-lex.europa.eu

Commission Implementing Regulation (EU) 2023/1194 (transitional provisions, amending 2022/2346) — eur-lex.europa.eu

MDCG 2021-24 Rev.1, Guidance on classification of medical devices (April 2026) — health.ec.europa.eu

MDCG 2023-5, Guidance on qualification and classification of Annex XVI products — health.ec.europa.eu

Manual on borderline and classification for medical devices, version 5 (April 2026) — health.ec.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Other device categories

We also cover dental hand instruments, medical device software, examination and surgical gloves, kinesiology tape and in vitro diagnostic reagents. The full list is on the device categories page, and country pages are in the list by country.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.