Skip to content

Legal Checklist for an Aesthetic Clinic in Poland

MDR, medical device advertising rules, GDPR, staff qualifications and documentation – a practical checklist for clinic owners.

Running an aesthetic medicine or cosmetology clinic involves not only treatments but also a range of legal obligations. The checklist below will help you organise the key areas. It is for information only and does not replace legal advice.

1. Medical devices (MDR)

  • you use only devices bearing the CE marking and an EU declaration of conformity;
  • you keep the instructions for use in Polish and use devices in accordance with their intended purpose;
  • you keep a device register with serial numbers / UDI, inspections and service;
  • you know the incident reporting procedure (to the manufacturer / distributor and to the President of URPL);
  • laser devices carry the laser class label, and the treatment room has laser zone signage and protective eyewear.

2. Advertising of medical devices and treatments

The Polish Medical Devices Act of 7 April 2022 (Art. 54–58) introduces detailed rules on advertising medical devices.

  • advertising must not mislead as to the intended purpose, safety and performance of the device;
  • advertising addressed to the general public may not, among other things, use the image of persons practising medical professions or suggesting such a profession (with certain exceptions);
  • devices intended for professional use only may not be advertised to the general public;
  • advertising of medical services is subject to the restrictions of the Code of Medical Ethics and medical chamber rules – information about the services provided is permitted;
  • "before and after" photos must be honest, unretouched and published with the patient's written consent.

3. GDPR and patient records

  • an information notice for patients and clients (Art. 13 GDPR);
  • health data is processed under Art. 9(2)(h) GDPR – to the extent necessary to perform the treatment;
  • a record of processing activities and, where needed, a risk assessment;
  • data processing agreements with booking system, accounting and IT providers;
  • staff authorisations and a data breach procedure (72 hours to notify UODO);
  • informed consent forms, medical history and treatment records stored in accordance with the law.

4. Qualifications and legal form

  • invasive procedures and those involving medicinal products are performed by a physician – a healthcare entity must be entered in the register of healthcare providers (RPWDL);
  • a cosmetologist performs treatments within the scope of their qualifications, with documented training on the specific device;
  • device and laser training certificates are kept in staff files;
  • professional liability insurance covering the treatments performed and devices used.

5. Sanitary and health & safety requirements

  • a sanitary opinion on the premises and hygiene procedures (disinfection, sterilisation, medical waste);
  • a contract for medical waste collection and BDO records, if applicable;
  • an occupational risk assessment for work with optical radiation;
  • workstation instructions for devices.

6. Consumers and sales

If you sell cosmetics or treatment packages to patients online, you need terms and conditions, information on the right of withdrawal and transparent pricing (including the lowest price in the previous 30 days for promotions).

Summary

Download our free "Clinic Legal Safety Checklist" to check your clinic step by step. We also discuss these topics in detail in the closed Future Life professional club.