MAXMED SYSTEMSOriginal CE-marked devices for licensed practices

Regulatory framework and compliance

EU compliance

What this page covers

This page sets out which regulations apply to the products I source, how regulatory responsibility is divided along the supply chain, and what documentation you receive.

How I work day to day is on the Operational profile page. The company and jurisdictional details are on the Corporate disclosure page.

My role, and its limits

MaxMed Systems coordinates procurement between licensed healthcare professionals and authorised European economic operators: manufacturers, licensed wholesalers and authorised distributors.

I do not manufacture, relabel, repackage, sterilise or store medical products, and the goods do not pass through my premises. Product conformity, technical documentation, CE marking, placing on the market and post-market surveillance remain the legal responsibility of the authorised operators in the chain.

My responsibility is narrower: to buy inside the EU from identified suppliers, to pass on accurate product and batch information, and to return your money in full if I cannot deliver what was confirmed.

Where I qualify as a distributor under Regulation (EU) 2017/745, the obligations it places on distributors apply to me.

Applicable regulation

The dermal fillers and injectable devices I source are regulated in the European Union under Regulation (EU) 2017/745 on medical devices. Products intended for facial or dermal filling without a medical purpose fall under Annex XVI of that Regulation and under the common specifications adopted in Regulation (EU) 2022/2346.

I source only CE-marked products, through operators established in the European Union.

What I do not supply

I do not supply prescription-only medicines. This includes botulinum toxin products, which are medicinal products and not medical devices in the European Union, and which require a pharmaceutical distribution authorisation that I do not hold and do not claim to hold.

If a product is classified as a medicinal product in your country, I will not supply it to you, whatever its classification elsewhere in the Union.

Documentation and traceability

With the goods you receive the lot number, the expiry date and the device identifier, printed on the packaging by the manufacturer. You can look the device and its manufacturer up in EUDAMED, the European Commission's public database of medical devices.

I no longer promise photographs of your boxes before dispatch. No supplier I work with releases them reliably, and a promise I cannot keep is worth nothing to you.

Every unit has at least twelve months of remaining shelf life when it reaches you. If what arrives has less, send it back and I refund it in full, including your return postage.

Technical documentation and declarations of conformity are held by the manufacturer or by the authorised distributor. If you need them, tell me and I will pass your request up the chain and send you whatever I receive.

Reducing the risk of falsified products

Falsified injectables are a documented problem in this market, and an unusually low price is the most common warning sign.

I am not the cheapest supplier in Europe and I do not try to be. My prices are below manufacturer list, because a discount is normal in this trade, but they are not far below it. If a price anywhere looks too good for the product, that is the point at which to ask questions, including if the price is mine.

What I do instead of competing on price:

I buy only inside the Union, and the goods are already on the EU market when I buy them. Where I buy directly from the manufacturer, I can show you the documentation. Where I buy from a distributor or a wholesaler, I name the supplier of your order on request, but I cannot show you the manufacturer’s authorisation for every brand.

The device identifier comes with the goods, and EUDAMED is public. You verify the device and its manufacturer yourself, rather than taking my word for the chain behind them.

You also receive the packaging security features to check on arrival (seals, holograms and the manufacturer's own markings) and the contact details of the manufacturer's representative in your country.

I will not suggest that a manufacturer will confirm an individual lot number on request. In most cases they do not. What they do investigate is a reported suspicion, and if you ever have one, I will raise it with them and provide my full supply chain documentation for that order.

If any product I have supplied is established not to be genuine, I refund it in full. This applies for as long as the product's stated shelf life runs.

Professional verification

Before confirming a procurement request, I verify your professional status and your entitlement to purchase these products. A copy of your practice authorisation is required once, before a first delivery.

This keeps the supply chain limited to licensed professionals and authorised institutions. Where eligibility cannot reasonably be established, I decline or discontinue the discussion.

National restrictions on use

Who may lawfully administer injectable aesthetic treatments is decided at national level and differs considerably between member states. In several countries these procedures are reserved to physicians, dentists or nurses with specific qualifications.

Compliance with the rules of your own country remains your responsibility as the practitioner. My verification does not replace it, and my confirmation of an order is not an assessment of your entitlement to perform any particular treatment.

Storage and transport

Goods are transported by tracked courier, in packaging suitable for the product, including temperature-controlled transport where the manufacturer requires it.

Responsibility for correct storage passes to you on delivery, in accordance with the manufacturer's instructions for use.

Nothing is binding without written confirmation

An enquiry, a price reference or a preliminary conversation confirms nothing by itself. A procurement relationship exists only once I issue written confirmation, and commercial terms apply from that point.

Nothing on this website constitutes a public offer, an invitation to purchase or a guarantee of availability.

Data protection

Professional and business data submitted to me is processed in accordance with Regulation (EU) 2016/679 and is used only for verification, procurement and the completion of your order. Details are set out in the Privacy policy.

Raising a concern

If you have a regulatory concern about any product, or about the way I operate, write to [email protected]. Every concern is answered in writing, so that you keep the record.

Last updated: October 2026