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Legal protection · 07

Knowing what you used, and on whom.

If a recall or an adverse event comes up, you must be able to say which product and which lot you used on which patient. Fillers, lasers and pulsed light fall under the European medical devices regulation even when the purpose is purely aesthetic.

Information, not legal advice. Read on 12 October 2026.

Product traceability

The rule

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Regulation (EU) 2017/745, Annex XVI

The medical devices regulation also applies to products without a medical purpose, including substances and elements «intended to be used for facial filling or other skin filling», equipment for reducing adipose tissue and those «such as lasers and intense pulsed light equipment» for skin treatments.

Read the textEUR-Lex

Product traceability

The precedents

In the institutional databases we consulted we found no decisions on this point in aesthetic medicine. We say so instead of filling the gap.

Product traceability

What protects the physician

  • For each session: trade name, lot, expiry date, UDI, site, number and volume of injections, who performed it, date.
  • The manufacturer's information sheet handed over before the treatment, and proof of delivery.
  • A procedure for reporting incidents and collecting complaints.

In Fibonacci

  • The lot number is recorded in the session as printed on the packaging: it is the key to tracing the patients who received it.
  • Product, quantity, areas and technique are in the same session, with expiry date and UDI.
  • A complication is recorded from the line of the session that originated it.

Product traceability

What these sources do not say

In the texts we read there is no general obligation of a "sheet with lot number" for every filler: recording site, number and volume is a manufacturer's recommendation, and the UDI obligation for individual practitioners awaits a decree. Noting the lot number remains the only way to respond to a recall.

Documentation must be done while you work, not when the lawyer's letter arrives.

In half an hour we show you how Fibonacci records consents, sessions, batches, and photos during the visit.

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