Ordering dental supplies online in Belgium: rules, returns and VAT

Gloves, composite, burs: most practices now order their consumables online, often from more than one webshop. It is fast, but it raises questions you used to ask the sales rep. Is that cheap product actually compliant? Can you simply send back a wrong order? And what does a foreign webshop mean for your VAT? In this article you will find what the rules say and what you can check yourself, with links to the official sources.

The same rules apply online

Much of what you order, from composite to burs and gloves, is a medical device. These fall under the European Regulation (EU) 2017/745 on medical devices (MDR). Article 6 is clear: a device offered online to someone in the EU must comply with the same regulation as any other device. A webshop is not a grey area.

This article covers medical devices and consumables. Medicines, such as anaesthetics, fall under separate rules that we do not cover here.

What your supplier must already check

Under Article 14 of the MDR, a distributor, including a webshop, must verify before selling a device that:

• the device bears the CE marking and an EU declaration of conformity has been drawn up;
• the required manufacturer information (label and instructions for use) is included;
• for imported products, the importer has put its details on the product or packaging;
• the manufacturer has assigned a UDI (Unique Device Identifier), where applicable.

The distributor must also make sure that storage and transport follow the manufacturer's conditions, and keep a register of complaints and recalls. If it suspects a product is not compliant, it may not make it available.

In Belgium, distributors of medical devices must also register their activity with the FAMHP (Royal Decree of 15 November 2017, Article 4). If you do not know a webshop, it is a fair question to ask whether it has that registration.

What you check yourself on delivery

You do not need to request a technical file, but the label tells you a lot. Annex I (section 23.2) of the MDR lists what it must show. On delivery, look mainly at:

• CE marking. If a notified body was involved in the assessment, its identification number appears next to the CE (Article 20).
• Manufacturer. Name and address of the manufacturer. If it is based outside the EU, also the name and address of its EU authorised representative.
• Lot or serial number and UDI carrier, usually a barcode or data matrix.
• Use-by date, at least year and month, where applicable.
• Storage conditions and, where applicable, the sterile indication (with the sterilisation method) and the indication that the device is single use.
• The indication that the product is a medical device.

Also keep your delivery notes or record the lot numbers. If a recall comes later, you can see straight away whether your lot is affected.

In which language?

The Belgian Law of 22 December 2020 on medical devices (Article 9) requires this information to be available in the three national languages. For devices used exclusively by healthcare professionals, it may be in English. As a user, you can then ask the manufacturer to provide it in the national language of your choice.

In doubt? Look it up in EUDAMED

EUDAMED is the European database on medical devices. On the public website, anyone can search for manufacturers, authorised representatives and importers, for devices by their UDI-DI, and for notified body certificates. Since 28 May 2026, use of the actor, device and certificate modules, among others, is mandatory (European Commission).

Two caveats. Transitional periods apply to devices already on the market, so a missing registration is not in itself a red flag. And distributors cannot register in EUDAMED (FAMHP): you will not find the webshop itself there, but you will find the manufacturer.

Ordered the wrong thing? No right of withdrawal

As a private individual, you can withdraw from an online purchase within 14 days. That right of withdrawal only applies to contracts between a business and a consumer (FPS Economy, in Dutch). When you order for your practice, you buy as a professional and do not have that legal right. What does apply is in the supplier's general terms and conditions. Read them before a first order, especially on these points:

• the period within which you can return items, and whether that includes opened or sterile packaging;
• who pays the shipping costs of a return;
• how and within what period you report a damaged or incorrect delivery.

VAT: compare prices including VAT

Medical care with a therapeutic purpose is exempt from VAT (Article 44 of the Belgian VAT Code). Treatments without a therapeutic purpose, such as purely aesthetic procedures, are taxable (FPS Finance, in French). If you only carry out exempt activities, you have no right to deduct VAT, so the VAT on your purchases is a real cost. Compare prices including VAT, even when a webshop shows them excluding VAT.

Ordering from a webshop in another EU country

If you only carry out exempt activities, a threshold of €11,200 per calendar year applies to goods bought from suppliers in other EU member states (FPS Finance, in French):

• Up to €11,200, you can choose. If you do not give your VAT number, the supplier charges its own country's VAT and you have no further obligations. If you do give it, you pay Belgian VAT through a special VAT return. That choice then applies to all your later purchases in that calendar year and the next two.
• Above €11,200, you must give your Belgian VAT number, file a special VAT return and pay Belgian VAT, until 31 December of the following calendar year.

The threshold counts your total purchases, not a single webshop. If you regularly order across the border or also carry out taxable treatments, talk to your accountant.

In the Netherlands

The Netherlands has no statutory cooling-off period for business purchases either: the 14 days apply to consumers, and between businesses the general terms apply (Ondernemersplein). Dental services are exempt from VAT (Belastingdienst). For businesses that do not file VAT returns, the threshold for purchases from other EU countries is €10,000 per year (Belastingdienst). The MDR and EUDAMED apply across the EU; in the Netherlands, supervision lies with the Health and Youth Care Inspectorate (IGJ).

And the price?

Price only matters once the product and the supplier are in order. To compare fairly, per unit and including shipping, read how to compare dental supply prices. The types of suppliers and how to choose are covered in dental suppliers in Belgium. How much you order each time depends on your minimum stock.

Order from all your suppliers in one cart

With Swyp, you order from the suppliers you already buy from, in one cart. Scout reviews your cart and proposes a cheaper split across your suppliers; you approve every change. You keep ordering from the same suppliers as today, and the checks above still apply. Try it free.

Sources

• Regulation (EU) 2017/745 on medical devices, Art. 6, 14, 20 and Annex I section 23.2
• Law of 22 December 2020 on medical devices (Dutch), Art. 9
• FAMHP, Registration of distribution and import activities and EUDAMED actor registration
• European Commission, EUDAMED overview
• FPS Economy, Right of withdrawal for distance purchases (Dutch)
• FPS Finance, VAT exemption for medical services and Special VAT return (French)
• Ondernemersplein, Cooling-off period; Belastingdienst, Threshold for purchases from EU countries (Dutch)