Legal basis

Laser tattoo removal. What the law says

This page describes European Union law and the way Poland applies it. The device rules — Annex XVI, class IIb, the transitional periods — bind every member state. The rules on who may operate the device are Polish, and stand here as the worked example. The rules changed twice in three years: in June 2023 for devices, in January 2026 for the people using them. Below we explain both, and what to ask any supplier before you sign.

Last reviewed · reviewed every six months

Żenia Malinin, co-founder of ModesticThis is not legal advice.

Everything on this page rests on European Union legal acts and on public registers that anyone can search.

  • MDR 2017/745
  • 2022/2346
  • 2022/2347
  • 2023/1194
  • NANDO
  • EUDAMED
  • Polish Medical Devices Act

01

Who may operate the laser?

Who may operate a device is decided by the manufacturer's instructions for use, not by the name of a profession.

02

May this device be sold at all?

Tattoo-removal lasers are class IIb. Since June 2023 they require a notified body. Devices already on the market rely on transitional periods.

03

What do I need to have in the clinic?

An optical-radiation risk assessment, training records, contraindications and consent forms. The list is shorter than it looks.

January 2026

Who may operate a laser in Poland

On 23 January 2026 the Minister of Health signed a position statement on the performance of aesthetic-reconstructive medicine procedures, published on 30 January. It reserves those procedures for physicians, and lists high-energy lasers among the devices concerned, including picosecond and nanosecond Nd:YAG.

The same document contains two sentences which, in practice, settle the matter for clinics. They are quoted here in full and in the original Polish, because a summary would change what they say.

„Wymienione procedury przeznaczone do wykonywania wyłącznie przez lekarzy nie obejmują (...) zabiegów wykonywanych na urządzeniach dopuszczonych do użytku przez inne osoby niż lekarze.”

Unofficial translation: The listed procedures intended to be performed exclusively by physicians do not include (...) treatments performed with devices approved for use by persons other than physicians.

Komunikat Ministra Zdrowia (Minister of Health position statement), RKLU.81223.2.2026.BB, 23 January 2026

„Jeżeli producent urządzenia wskazuje w ulotce innych użytkowników niż lekarzy, to tym samym określa jakie parametry użytkowania, jako nie stwarzające ryzyka zagrożenia zdrowia i wystąpienia powikłań.”

Unofficial translation: If the manufacturer of the device indicates in the information leaflet users other than physicians, it thereby determines which operating parameters do not create a risk to health or of complications.

Ibid.
The instructions for use decideIt is the manufacturer that states, in the instructions for use, who may operate the device and at which parameters. Not a job title, and not a training certificate.
Silence counts against youIf the instructions for use do not indicate users other than physicians, the default answer applies: physicians only.
Hence the first questionIt is not "am I allowed to use this". It is "what exactly do the Polish-language instructions for use say".
A position statement is not a source of lawThe Ministry says so itself. The ordinary and administrative courts are not bound by it. It is the ministry’s position, which would be taken into account in any dispute, but it does not replace a statute. We say this because a page presenting the statement as legislation would mislead.

Calendar

Where we are today

The path of the device follows EU law and has three phases. The path of the person operating it follows Polish law, and has already happened in full.

until 22.06.2023

Ordinary product

CE marking under the Low Voltage and Electromagnetic Compatibility Directives. No notified body.

22.06.2023 – 31.12.2028

Transitional period

Regulated device, class IIb. Devices placed on the market earlier may be sold on transitional terms.

Today · 23.08.2026

01.01.2027written agreement with a notified body required

from 01.01.2029

Full MDR

Only with a notified-body certificate issued under Regulation 2017/745.

Who may operate · Polish rules

  1. 26.05.2021EUMDR becomes applicable
  2. 26.05.2022PLPolish Medical Devices Act
  3. 01.01.2023PLRules on advertising devices
  4. 22.06.2023EUAnnex XVI, class IIb
  5. 08.07.2023PLProfessional skills of physicians
  6. 30.01.2026PLMinistry of Health position statementlatest change
  7. 28.05.2026EUEUDAMED becomes mandatory
  8. Today · 23.08.2026
  9. 01.01.2027EUAgreement with a notified body required
  10. 31.12.2028EUEnd of the transitional period
  11. 01.01.2029EUFull MDR

Omitted for readability: 22 December 2024, the deadline for notifying a clinical investigation, and 31 December 2029, the extended end of the transitional period for the clinical-investigation route. Both dates concern a minority of the devices on the market.

June 2023

What this means for the device you are buying

Until 22 June 2023 a tattoo-removal laser could be an ordinary product CE-marked under the Low Voltage and Electromagnetic Compatibility Directives. From that day it is a regulated device. Regulation 2022/2347 classified these devices as class IIb, and class IIb always requires the involvement of a notified body.

Devices already on the market benefit from transitional periods. There are two routes, and they differ in their conditions and their dates.

Route A

Medical device on a legacy certificate

Article 120 MDR. Requires a notified-body certificate issued under Directive 93/42/EEC, an application lodged by 26 May 2024, and a written agreement with the body signed by 26 September 2024. Also no significant change in design or intended purpose.

Period ends: 31 December 2028

Route B

Device without an intended medical purpose

Annex XVI, Article 2 of Regulation 2022/2346. Requires lawful presence on the EU market before 22 June 2023 and no significant change. From 1 January 2027 a signed agreement with a notified body is required in addition. Without it the device may not be placed on the market from that date.

Period ends: 31 December 2028

An expired certificate is not always a problemCertificates issued under Directive 93/42/EEC expired as a rule on 26 May 2024. A device covered by Article 120 may lawfully be sold despite that expiry, provided it meets the conditions of that route. The expiry date on its own therefore settles nothing. What settles it is whether the application and the agreement with the notified body are in place, and whether the body has taken over surveillance of the device.

In short

Our devices

Three lasers, two transitional routes. You can check the numbers below yourself: the notified body in the NANDO database, the economic operator in EUDAMED.

ModelTypeClassRouteNotified bodyTransitional period until
Modestic™ EdgeNd:YAG Q-SwitchIIbA · Article 120 MDRTÜV Rheinland LGA Products, 019731.12.2028
Modestic™ PicoNd:YAG picosecondIIbA · Article 120 MDRTÜV Rheinland LGA Products, 019731.12.2028
Modestic™ UltraNd:YAG Q-SwitchIIbB · Annex XVIApplication in progress31.12.2028
What these numbers meanThe number 0197 identifies the notified body in the EU NANDO database. Certificate HD 60145599 0001 was issued under Directive 93/42/EEC and expired on 26 May 2024, which is the correct state of affairs for Route A: the conformity-assessment application was received on 25 April 2024 and the agreement with the body was signed before 26 September 2024. We make the documents available to customers at the point of purchase.

Before you sign

What to ask any supplier

Eight questions. The answers should be available before purchase, not after delivery. Four of them you can verify yourself, in public databases, without going through the seller.

  1. 01Ask for the instructions for use in PolishThe MDR requires instructions in the official language of the country. It is the same document that decides who may operate the device. One question, three answers at once.
  2. 02What is the certificate number and the notified-body number?You can check the body yourself in the European Commission’s NANDO database. A number that cannot be verified is not evidence.
  3. 03What is the device class, and under which rule?Tattoo-removal lasers are class IIb. Class I on a device like this is a signal that something needs explaining.
  4. 04Was the device lawfully on the EU market before 22 June 2023?Whether it is entitled to a transitional period at all depends on this. Confirmation comes from the manufacturer, not from the date of first import into Poland.
  5. 05Has an agreement with a notified body been signed?For Annex XVI devices it is required from 1 January 2027. An application lodged is not the same as an agreement signed.
  6. 06Is the manufacturer registered in EUDAMED?Registration of economic operators has been mandatory since 28 May 2026. You can check the SRN yourself.
  7. 07Has the distributor submitted a notification to the President of URPL?Polish Medical Devices Act, Articles 21 to 23. The deadline is 7 days from placing the first device on the territory of Poland.
  8. 08Who is responsible for servicing and for reporting incidents?The obligation to report a serious incident also rests on the user of the device. It is worth knowing in advance which number to call.
A notification is not a registrationThe Office states plainly that submitting a notification does not lead to registration of the device. The phrase "registered with URPL" therefore describes no real status, no matter who uses it. The correct formulation is: a notification submitted in accordance with Article 21 of the Medical Devices Act.

On the clinic

What is yours to do

Optical-radiation risk assessmentRequired by the regulation on occupational health and safety in work involving exposure to optical radiation. An employer obligation, including in a small clinic.
Training, and the record of itThe common specifications oblige the manufacturer to provide training covering safe use of the device and what to do in the event of an incident. Keep the certificate with the instructions for use.
Contraindications and consultationThe instructions for use must state on whom, and on which skin, the treatment must not be performed. The common specifications recommend a medical consultation with an assessment of the skin before treatment.
Reporting incidentsA serious incident is reported to the manufacturer and to the President of URPL. The obligation applies to the user of the device as well, not only to the manufacturer and the distributor.

Verification

Sources

Every sentence on this page can be checked against its source document. The full list is below.

Have a question about the documentation for a specific device?

Write to info@modestic.pl →