EU Authorized Representative for Kinesiology Tape Manufacturers: Qualification, Class I and Labelling Claims

Is kinesiology tape a medical device?

The MDR does not list kinesiology tape by name. The question is answered by the definition in Article 2(1), which turns on what the manufacturer intends:

"‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:" (MDR Article 2(1))

The purpose most relevant to tape is the second indent:

"— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability," (MDR Article 2(1))

Intended purpose is not read from the product alone. The MDR defines it by reference to everything the manufacturer publishes:

"‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;" (MDR Article 2(12))

A roll of elastic cotton tape sold for athletic performance, muscle warmth or appearance, with no reference to injury, pain or a condition, falls outside the definition. The same roll sold with application guides for knee pain, ankle sprains, lymphoedema or post-operative swelling is a medical device. The physical product does not change; the manufacturer's statements do.

Classification: Rule 1, with Rule 4 as the main exception

Tape is applied to the surface of the skin and does not penetrate the body, so it is non-invasive. The default rule for non-invasive devices is Rule 1:

"Rule 1 All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies." (MDR Annex VIII, Rule 1)

MDCG 2021-24 Rev.1 gives, as Rule 1 examples, "Devices used to immobilise body parts and/or to apply force or compression on them (e.g. non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery)". Therapeutic taping on intact skin fits this description.

Rule 4 applies when the tape is intended to contact injured skin:

"Rule 4 All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: — class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;" (MDR Annex VIII, Rule 4)

The same rule continues:

"— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and — class IIa in all other cases." (MDR Annex VIII, Rule 4)

Most kinesiology tape is applied to intact skin and never meets Rule 4. Where the instructions describe application over abrasions, surgical wounds or scars that are not yet closed, Rule 4 must be considered, and the precise claim decides between class I and class IIa.

Product variants and their class

Pre-cut shapes, colours and roll widths of the same tape usually form one device family for registration. A different adhesive, a sterile version or an added substance does not.

Class I obligations still apply in full

Class I status removes the notified body, not the obligations. Article 52(7) sets the route:

"7. Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III." (MDR Article 52(7))

For tape supplied sterile, the same paragraph brings in a notified body for the sterile aspects:

"If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." (MDR Article 52(7))

The technical documentation must address, among other things, biological evaluation of the adhesive and textile in prolonged skin contact, where EN ISO 10993-1:2025 is cited as a harmonised standard under the MDR; risk management, where EN ISO 14971:2019 is cited; a clinical evaluation under Article 61 that supports each therapeutic claim; and a post-market surveillance plan. The manufacturer must also have access to a person responsible for regulatory compliance under Article 15, assign a Basic UDI-DI and register the device in EUDAMED under Article 29.

Labelling claims that change the status of a tape

One claim is enough. A product described as sports tape everywhere except for one leaflet about sprain treatment is a medical device, because Article 2(12) counts promotional and sales materials.

Distributor marketing counts. If a distributor changes the intended purpose of a tape already on the market, Article 16(1)(b) makes it assume the manufacturer's obligations. Manufacturers should control how their tape is presented by resellers.

Claims must be supported. Article 7 prohibits labelling and advertising that ascribe to a device functions or properties it does not have. Statements about pain reduction, lymphatic drainage or faster recovery need clinical evidence in the clinical evaluation.

Dual catalogues create confusion. Selling the same tape as a device under one name and as a non-device under another, with no difference in product or instructions, invites questions from market surveillance authorities. A clear separation of intended purpose, labelling and documentation is needed.

What Medex does under the mandate

Once the tape is a device, Article 11(1) applies regardless of class:

"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 and technical documentation have been drawn up, and for sterile tape that the notified body procedure has been carried out; keep copies at the disposal of competent authorities; complete our own actor registration and check your UDI and device registrations; forward authority requests; cooperate on corrective actions; and pass on complaints and incident reports without delay. A person responsible for regulatory compliance is available in-house, as Article 15(6) requires.

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", so 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 orthoses, braces and supports, wheelchairs and mobility aids and examination and surgical gloves. 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 wound dressings.

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 tape is sold only for sports. Does it need an EU authorised representative?

Not under the MDR, provided nothing on the label, in the instructions or in promotional material presents it for a medical purpose. If any material refers to treating or alleviating an injury, the tape is a device and Article 11(1) applies.

Is class I kinesiology tape exempt from a notified body?

Yes, if it is non-sterile and applied to intact skin or used over injured skin only as a mechanical barrier or for compression. Sterile tape needs a notified body for the sterility aspects under Article 52(7).

Do different colours and pre-cut shapes need separate registrations?

Usually not, where the materials, adhesive and intended purpose are the same. A different adhesive, a sterile version or an added substance creates a different device.

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 in the EU or in Türkiye.

Sources

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

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

European Commission, Summary list of harmonised standards (Regulation (EU) 2017/745) — single-market-economy.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 in vitro diagnostic reagents, dental devices, wound dressings, reusable surgical instruments and condoms. 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.