Is the class of a medical device decided by the manufacturer or the authority?

The manufacturer decides it by applying the 22 rules of Annex VIII of the MDR to the intended purpose of the product. The authority does not assign the class: it verifies that the manufacturer has calculated it correctly.

Can a distributor sell a Class III product without having anything special?

Yes, if the product meets all MDR requirements and is accompanied by complete documentation. The distributor's obligations are the same for any class: verify the CE marking, language, importer details, and UDI.

What changes between the classes for the pharmacist or orthopaedic specialist?

In practice, what changes is the level of documentation the manufacturer must be able to present. The higher the class, the more demanding the evaluation. Your obligation to verify does not depend on the class.

Is the UDI mandatory for all medical devices?

The UDI is mandatory as established by Article 10 of the MDR and the applicable UDI regulation. It does not depend directly on the class: a Class I product may also require a UDI if the regulation requires it for that type of product.

Medical device classes: what changes for the distributor

You receive an order for digital thermometers, a pair of crutches, and a batch of contact lenses. In the documentation the supplier has sent you, you see that each item has a different class: Class I, Class IIa, Class IIb. Where does that letter come from and why does it matter to you? This is what Regulation (EU) 2017/745, the MDR, explains — the regulation that governs medical devices throughout the European Union since May 2021.

Pharmacy counter with medical devices of different classes: thermometer, crutches, box of contact lenses, and bandages. — Products of different classes share the counter. Your obligation is to check the documentation, not to classify them.

Who Decides the Class of a Product?

The class is decided by the manufacturer, not the authority or the distributor. The manufacturer applies the 22 rules of Annex VIII of the MDR to the intended purpose of their product and determines whether it is Class I, IIa, IIb, or III. As a general rule, products with a higher inherent risk move up a class. This is set out in Article 51 of the Regulation.

What reaches you is the outcome of that internal work by the manufacturer. You do not have to classify anything: your obligation is to verify that the documentation accompanying the product is correct (Article 14.2 of the MDR).

What Does Each Class Mean in Practice?

Class I: low- to moderate-risk products. These are the ones most commonly seen in pharmacies and orthopaedic shops: bandages, insoles, thermometers without a specific measurement function. The manufacturer can declare them conforming themselves, without a notified body, unless they are sold sterile, have a measurement function, or are reusable surgical instruments (Article 52.7).

Class IIa: moderate-to-high risk. For example, dental scanners or physiotherapy equipment. They require the involvement of a notified body.

Class IIb: high risk. The manufacturer needs a more demanding certificate.

Class III: the highest risk class. Cardiac implants, mechanical heart valves, other products that remain inside the body. They require the strictest evaluation before being placed on the market.

Box of a medical device in the warehouse, waiting to be checked before reaching the point of sale. — The manufacturer assigns the class; the distributor verifies that the documentation accompanies the product to the point of sale.

What Does the Distributor Have to Do with the Class?

Your work begins where the manufacturer's ends. Before selling a product, you must check four things under Article 14.2:

That it bears the CE marking and a EU declaration of conformity has been drawn up.
That it is accompanied by the information the manufacturer must provide (label and instructions for use in the required language).
That the importer, if there is one, has indicated their details on the product.
That the manufacturer has assigned a unique device identifier (UDI) where applicable.

The class does not change your checklist. What changes is that the higher the class, the stricter the control the manufacturer has had to undergo, and this is reflected in the certificates and documentation they must provide you.

What Is the UDI and Why Does It Appear Alongside the Class?

The UDI (Unique Device Identifier) is a code that makes it possible to track each product unit throughout the entire supply chain. Its appearance does not depend directly on the class, but on what Article 10 of the MDR and the applicable UDI regulation require. If you see it on the label or in the manufacturer's documentation, check that it is actually present: it is one of the four points you must verify.

You can learn more about how to read that code in our article on UDI on a medical device label: how to read it and what the distributor must keep.

Where Does Eudamed Fit In?

Since 28 May 2026, the first four modules of EUDAMED are mandatory in the European Union. This database collects the registration of economic operators, the UDI and product registration, notified bodies and certificates, and market surveillance activities. The vigilance and clinical investigations modules are not yet mandatory.

Eudamed does not change the distributor's obligations already set out in the MDR: it is a tool for authorities to coordinate information. Your obligation remains that of Article 14.2, and the product class tells you what level of documentation to request from the supplier.

Quick Questions

Can a distributor change the class of a product?

No. The class is assigned by the manufacturer applying the rules of Annex VIII. If a distributor changes the intended purpose of the product, they then assume the manufacturer's obligations under Article 16.1 of the MDR, but that is a different situation.

What if the product I receive does not have a label in Spanish?

This is one of the points you must check under Article 14.2. If information in the required language is missing, you cannot place the product on the market. You must claim from the supplier.

Does the class affect the activity start notification?

The class does not change who is exempt from filing an activity notification or who must do so. To find out whether your establishment needs to file that notification, see the relevant article on activity start notifications for medical devices.

Can a Class I product require a notified body?

Yes, in three cases: if sold sterile, if it has a measurement function, or if it is a reusable surgical instrument. In these cases, even though the class is I, the manufacturer needs a notified body to intervene only for that specific aspect (Article 52.7).

What to Do This Week

Review your best-selling products and check that the supplier's documentation includes the assigned class. If it is missing, request it using our template for an email to request documentation from your supplier.

Compare the class indicated by the manufacturer with what you see on the product: that the CE marking is present, that the label has the UDI where applicable, and that the information is in Spanish.

Keep copies of the EU declarations of conformity and the certificates delivered by your supplier. The manufacturer must keep them for at least 10 years from when the product was placed on the market (Article 10.8); you must be able to produce them if asked.

The class of a product is not decorative information. It tells you how much regulatory work the manufacturer has done before reaching your shelf. Your obligation is not to repeat that work, but to verify that it has been done and to keep a record of it.

Sources: Regulation (EU) 2017/745 · Real Decreto 192/2023 · EUDAMED

Class I, IIa, IIb or III: What Changes for You Depending on the Product Class