EU Authorized Representative for Orthosis, Brace and Support Manufacturers: Class I, No Notified Body, One Mandatory Appointment

Is your brace a medical device?

The support market runs from spinal orthoses prescribed after surgery to elastic sleeves sold in sports shops, and the same factory often makes both. The dividing line is the intended purpose you state, measured against Article 2(1):

"'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: … — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,"

A lumbar orthosis intended to immobilise the spine after a fracture is squarely inside that definition. A neoprene sleeve sold to keep a runner's knee warm is not — until the packaging says it treats an injury, at which point it is, and needs the whole file behind it.

The claim is what decides. Manufacturers regularly build a non-device product and then hand marketing a free hand with the copy, and the copy makes it a device. If you intend to sell both ranges into the Union, separate them at the packaging stage and keep the therapeutic language out of the non-device line.

Class I under Rule 1, and the case where Rule 4 takes over

Orthoses are non-invasive. The residual rule catches them:

"All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies."

That holds for the ordinary case — a brace worn over intact skin. Rule 4 takes over when the device is intended for contact with injured skin:

"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; … — 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."

Compression keeps you in class I. This is why a compression garment and a post-surgical support stay class I even where the skin underneath is not intact. Where files fail is the "manage the micro-environment" indent: a brace with a silicone gel pad marketed for scar management is no longer a mechanical barrier, and class IIa brings a notified body with it. The gel pad is not the problem. The scar-management claim is.

Custom-made, or only adapted?

Orthotics is the category where "custom-made" is claimed most often and qualifies least often. Article 2(3) sets a demanding test and then, in its second paragraph, closes the door most manufacturers try to walk through:

"'custom-made device' means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;"

Read the second sentence twice. A brace produced on a line and then heat-moulded, trimmed or strapped to fit a patient is not custom-made. Neither is a device mass-produced industrially against a prescription. Both are ordinary class I devices that must be CE marked, registered and declared like any other.

The consequence matters commercially. Custom-made devices follow Annex XIII and are not CE marked; ordinary devices are. A manufacturer who has told its EU customers that its adjustable orthoses are custom-made has told them the products do not need a CE mark, and that is the version the customs authority will disagree with.

What replaces the notified body

Nothing about class I removes the technical documentation. Annexes II and III still apply in full: intended purpose, design and manufacturing information, general safety and performance requirements with the evidence for each, benefit-risk analysis, risk management, verification and validation, and a post-market surveillance plan. For orthoses, the sections most often thin are:

Biocompatibility. Prolonged skin contact. Foam, neoprene, elastic, adhesive, plastic stays, metal rivets — every material touching the patient needs its evaluation, and a supplier's general statement is not one.

Mechanical performance. The force a brace applies, the strength of its closures, the fatigue life of its hinges. If a claim on the box says "immobilises", something in the file has to show it does.

Clinical evaluation. Class I devices are not exempt. For a well-established design the route is normally literature plus equivalence, but it has to be written and it has to be about your device.

Post-market surveillance. A plan under Article 83 and a PMS report under Article 85 exist for class I too.

Registration, sizes and colours

Orthosis catalogues explode at the SKU level: five sizes, two colours, left and right. Sizes and colours of the same brace belong under one Basic UDI-DI. A change of material or of intended purpose splits it. Getting the grouping right before you register is cheaper than correcting EUDAMED afterwards.

Your authorized representative carries its own registration obligation and verifies yours, under Article 11(3)(c):

"(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;"

We manufacture in this category ourselves

Medex is registered as a manufacturer of corset-type orthoses in Türkiye's national database and holds its own EUDAMED manufacturer registration alongside its authorized representative registration. We have built these files for our own products before building them for clients, which is a narrow claim and a useful one: when we say a biocompatibility section is thin or a clinical evaluation is not going to survive a question, it is because we have answered that question for our own devices.

A frequent question at this point is whether the Union and Türkiye need separate representatives. They do not. Article 11(1) requires a sole authorised representative for the devices concerned, and under the EU–Türkiye Customs Union arrangement that representative may be established in the Union or in Türkiye. One appointment, covering the Union market and Türkiye — not one for each. Our registered place of business is in Türkiye and our EUDAMED authorized representative identifier is TR-AR-000057550; the arrangement is set out in the European Commission's Notice to Stakeholders of March 2022 and described in MDCG 2022-16.

Where you are established changes the starting point

The classification above is the same wherever the instrument is made. What differs by country is everything around it: the national approval you already hold and what it does not carry into the Union, the authentication route your documents have to travel, and whether your European customers expect you or them to hold the CE file. We keep a separate page for each of the main exporting countries in this sector — China, Pakistan and Türkiye.

If your country is not listed there, the mandate works the same way; send your device list and we will tell you which route applies. A full list of the categories we cover is on the device category page.

Frequently asked questions

Our braces are class I. Do we really need an EU authorized representative?

Yes. Article 11(1) turns on where the manufacturer is established, not on the class. A class I brace from a non-EU manufacturer cannot be placed on the Union market without a designated sole authorized representative.

Is a sports support a medical device?

Only if you say so. Without a medical intended purpose it is not a device. With a claim to treat or alleviate an injury it is, and the full class I file applies.

We adjust every brace to the patient. Are they custom-made?

Almost certainly not. Article 2(3) expressly excludes mass-produced devices adapted to a professional user's requirements. Adaptation at the point of fitting does not make a device custom-made.

Does a compression garment stay class I if it goes over a healing wound?

Yes, where it is intended for compression — that is the first indent of Rule 4. It moves to class IIa if it is principally intended to manage the micro-environment of the injured skin.

Do class I devices need a clinical evaluation?

Yes. The route is usually lighter, but Article 61 and Annex XIV apply regardless of class.

Can we use one Basic UDI-DI for the whole size range?

Sizes and colours of the same device, yes. Different materials or intended purposes, no.

Sources and further reading

Regulation (EU) 2017/745 (MDR), consolidated text — Article 2(1) and 2(3), Article 11, Articles 61, 83 and 85, Annexes II, III, VIII (Rules 1 and 4) and XIII — EUR-Lex, CELEX 02017R0745-20230320

European Commission, health.ec.europa.eu — medical devices, EUDAMED

MDCG 2022-16; European Commission Notice to Stakeholders, March 2022

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