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Knowledge/Law and Regulation
LAW AND REGULATION

Documents instead of shortcuts.

How we approach regulatory and legal questions.

We always present the regulatory status of a device and legal questions according to the specific product, decision, jurisdiction, and date — not according to a general impression or the device's name. For foreign-language documents, we publish a working Slovak translation together with a link to the original.

Documentation is being added on an ongoing basis

Specific product

Actismile is a multifunctional intraoral activator made by Triadent Srl — we assess its status only based on this specific product, not on activators in general.

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The EU regulation on medical devices (MDR) distinguishes several categories of devices with different rules — for example, a "custom-made" device and a "mass-produced, patient-matched" device. Importantly: if a dentist merely selects or adjusts a mass-produced product for a specific patient, this does not automatically make the product "custom-made" — that is a separate category with its own, stricter conditions.

Actismile is sold in several standard shapes, hardnesses, and sizes — so under this definition it is more of a mass-produced, patient-matched product than a custom-made device. This means the standard conformity assessment procedure should apply to it, not the exception intended for custom-made devices — which is exactly why we are looking for specific documents alongside this, not just general statements from the manufacturer.

Primary documents

To confirm the MDR class, we would need the EU Declaration of Conformity, the intended purpose, and the UDI. We have not yet found any of these documents publicly.

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  • EU Declaration of Conformity — a document by which the manufacturer, on its own responsibility, confirms that the product meets the MDR requirements for that device class.
  • MDR class — medical devices are divided into classes according to risk (e.g. I, IIa, IIb, III); the class determines how strict the verification and documentation requirements are.
  • Intended purpose — the precise use of the product as defined by the manufacturer; it determines whether the product falls under the MDR at all, and into which class.
  • IFU (Instructions for Use) — instructions for use containing clinically relevant information and warnings.
  • UDI (Unique Device Identification) — a unique device identifier that allows it to be tracked in medical device databases.

Without these documents, we cannot say which category Actismile belongs to, nor which requirements apply to it — so we label it neither as a confirmed medical device nor as a device outside this regulation.

Decisions and proceedings

For Actismile, we have not yet found any judicial or administrative decision — neither one that would classify it as a medical device, nor the opposite.

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This distinction matters: sometimes a claim appears that since "no one has said it is a medical device", the product therefore is not one. This is a logical fallacy — an absent decision is not a decision. Until a specific document is found (a registration, a certificate, or conversely an official decision that the product is exempt from the MDR), the status remains undetermined — neither disproven nor confirmed.

If a relevant decision from a court or regulatory authority appears, or a direct response from Triadent with supporting documentation, we will update this page.

CURRENT CASE

Actismile (Triadent) — what we know and what we don't

Actismile is an activator made by Triadent that is commonly used in Dentosofia practice. You repeatedly ask us whether it is a medical device. The answer, for now, is: we cannot reliably confirm or refute this — and below we explain exactly why.

What is confirmed

Triadent Srl publicly sells Actismile as a multifunctional/plurifunctional intraoral activator, available in several standard shapes, hardnesses, and sizes. The Italian Ministry of Health maintains a public database of registered medical devices, searchable by manufacturer, product, and classification.

More about the activator →

What is not yet confirmed

We have not found, in any publicly available source, a specific entry for Actismile in a medical device database, its MDR class, an EU Declaration of Conformity, its intended purpose, or a UDI. Nor have we found a decision stating that the product is not a medical device.

LEGISLATION

EU MDR 2017/745

EU regulation on medical devices — the basic legal framework for their classification.

GUIDANCE

MDCG 2021-24

European Commission guidance on the classification of medical devices.

GUIDANCE

MDCG 2021-3

Guidance on custom-made devices and patient-matched devices.

PRIMARY SOURCE

Triadent — Actismile

The manufacturer's current product page.

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IMPORTANT NOTICE — The method described in the articles, videos, and consultations on this website is not, and cannot be considered, a medical service or healthcare. It does not constitute diagnosis, treatment, or a substitute for professional medical care.