What the EU Regulates in Aesthetics and What Is National
European law decides whether an aesthetic product may be sold in the EU. It does not decide who may inject it, and it places the main duty to report a complication on the manufacturer, not on you.
So there are three separate questions. Fillers and aesthetic lasers fall under the EU Medical Devices Regulation, even when they have no medical purpose, and botulinum toxin falls under medicines law. Who may administer them, and whether you must report a problem, is set by the law of the country where you practise.
Fillers and aesthetic lasers fall under the device regulation, even with no medical purpose
The Medical Devices Regulation, Regulation (EU) 2017/745, also covers a list of products with no intended medical purpose. Its Annex XVI includes substances or items for facial, dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. A separate group covers equipment emitting high intensity electromagnetic radiation, such as lasers and intense pulsed light, for skin resurfacing, tattoo or hair removal or other skin treatment [1].
A filler or a laser used purely for appearance is therefore inside the device regime. Common specifications for these groups were laid down in Commission Implementing Regulation (EU) 2022/2346 and apply from 22 June 2023 [2]. Transitional provisions still allow products lawfully marketed before that date to stay on sale for some years [2]. A product on the shelf today has not necessarily been assessed against the common specifications.
Botulinum toxin falls under medicines law instead
Botulinum toxin works by pharmacological action, which is what makes a product a medicinal product under Directive 2001/83/EC [3]. So filler and toxin fall under two unrelated systems, with different rules on supply, prescription and advertising.
EU law requires every member state to prohibit advertising prescription-only medicines to the general public, and botulinum toxin is prescription-only [3]. Filler, as a device, has no equivalent EU-wide advertising ban. The reason is its legal category, not its risk.
Who may inject is decided by your country
The device Regulation does not license practitioners. It states that it does not affect national law on the organisation and delivery of health services. That includes any requirement that only certain health professionals or institutions may dispense or use certain devices [1].
Under the common specifications, which apply from 22 June 2023, a dermal filler must carry a statement on its label and at the head of its instructions for use, though products sold under the transitional provisions may not yet carry it [2]. The statement appears in the largest bold type used. It says that the product is only to be administered by appropriately trained healthcare professionals, qualified or accredited in accordance with national law. It must also state clearly that it is not for use in anyone under 18 [2].
That sets an EU expectation that a healthcare professional administers the product, then leaves the meaning of qualified or accredited to each country. Whether a nurse, a dentist, a beautician or only a physician may inject is national law, and it differs sharply across the EU.
Finland shows the gap. Finnish law does not require healthcare training for people who perform dermal filler treatments. A registry study examined all 25 complaints to Finnish regulatory authorities in the eight years to the end of 2024, and 56 per cent concerned treatments in beauty salons. The practitioner was a salon employee in 11 cases, a registered nurse in 6 and a doctor in 2, and could not be identified in 6 [4].
These 25 complaints are not an incidence rate or a ranking of who injects most safely. The authors excluded the Patient Insurance Centre, which normally handles complications caused by healthcare professionals, so cases treated by doctors and nurses are under-counted [4].
The legal duty to report sits mainly with the manufacturer
Under the Medical Devices Regulation, manufacturers must report serious incidents to the competent authorities. Expected side-effects already documented in the product information and quantified in the technical file are handled by trend reporting instead. For healthcare professionals, users and patients, member states must take measures, such as targeted information campaigns, to encourage and enable them to report suspected serious incidents [1].
Encouraging and enabling is not requiring. Where a practitioner has a duty to report, it comes from national law, and several member states impose one. The safety picture assembled centrally therefore rests largely on what manufacturers submit. A review of the complications literature and media reporting concluded that complications of non-surgical aesthetic treatments remain underreported, inadequately studied and inconsistently regulated [5].
How to find the answer for your own country
- Separate the three questions. Whether the product may be sold here depends on CE marking and the manufacturer. Whether you may administer it is a question for your national regulator or professional body. A duty to report comes from national law, not the Regulation.
- Do not read a CE mark as permission. It shows the manufacturer met the requirements for placing the product on the market. It says nothing about your qualification, the indication or your patient.
- Check your scope of practice before you book a course. A training certificate records what you were taught; it does not authorise you to do it.
- Report complications even where it is voluntary. A complication nobody hears about is one nobody can act on.
Before booking, ask the training provider two things: who may perform this treatment where you practise, and what evidence of training your regulator will want.