Standards and guidelines concerning the quality and safety of medical treatment in Poland

Standards and guidelines regarding the quality and safety of medical treatment in Poland are set out in various legal acts and documents – ranging from acts and ordinances, through orders of the President of the National Health Fund (NFZ) and codes of ethics for medical professions, to recommendations issued by scientific societies. In addition, organizational requirements for healthcare in specific fields of medicine or for entities performing particular medical activities, have been developed by the Minister of Health in the form of binding standards.

MEDICAL ACTIVITY

With regard to healthcare providers operating within the public healthcare system, the requirements for entities applying for a contract are set out by the Minister of Health in ordinances on guaranteed healthcare benefits, and by the President of the National Health Fund (NFZ) in issued orders. The implementation of these contracts is supervised by the National Health Fund.

A medical facility may commence operations only after being entered in the Register of Entities Performing Medical Activity (RPWDL). At the application stage, verification is carried out to ensure that formal requirements are met. However, the assessment of whether the facility complies with the legal requirements for conducting medical activities covered by register entry takes place only after the registration has been made, as part of supervisory procedures.

Supervision over the provision of healthcare services is exercised by:

• the Minister of Health,
• the Chief Sanitary Inspector with the assistance of the State Sanitary Inspection,
• voivodes,
• the founding bodies of healthcare entities,
• medical professional chambers.

An important element of specialist supervision in healthcare are national and regional consultants in specific fields of medicine. They perform advisory, consultative, and supervisory functions for government administration bodies, entities establishing healthcare institutions, and the National Health Fund.

Every medical facility is required to meet quality and safety standards in the provision of healthcare services, in particular with regard to:

• the premises where the activity is to be carried out,
• medical equipment, including requirements for specific types of equipment and the conditions such equipment must meet,
• medical devices,
• medical personnel,
• the provision of health resort treatment in a location with health resort status.

Medical facilities are also required to take out compulsory civil liability insurance covering damages resulting from the provision of healthcare services or from the unlawful failure to provide such services, as well as adverse medical events. Information on civil liability insurance policies is recorded in the facility's register maintained by the relevant voivode.

The quality and safety of treatment provided by a given medical facility may also be confirmed by quality certificates (e.g., ISO 9001) and accreditation certificates. Both the accreditation process and the procedures for obtaining certificates are voluntary.
Information on certificates and accreditations is recorded in the RPWDL and is taken into account when contracting healthcare services by the National Health Fund.
The list of accredited entities is maintained by the Center for Quality Monitoring in Healthcare (CMJ).

Inspection of healthcare entities
Pursuant to the Act on Medical Activity, the Minister of Health and entities authorized by him are entitled to inspect entities performing medical activities with regard to compliance with applicable regulations and medical standards, in particular:

• voivodes,
• national consultants,
• subordinate organizational units (e.g., the National Health Fund),
• governing bodies of medical professional chambers,
• medical scientific societies,
• medical universities,
• research institutes,
• specialists in specific fields of medicine.

The inspection covers, inter alia:

• the implementation of tasks specified in the organizational regulations and statutes,
• the availability and quality of healthcare services,
• the proper management of property and public funds.

Inspectors, acting on the basis of appropriate authorization, are entitled to:

• visit premises,
• observe activities related to the provision of healthcare services in a manner that does not violate patient rights,
• evaluate medical records obtained,
• review information and documentation other than medical records,
• assess the implementation of tasks specified in the organizational regulations with respect to the availability and quality of services provided,
• assess the management of property and public funds,
• request oral and written explanations from the manager and employees of the healthcare entity,
• secure evidence.

On the bases of inspection findings, the entity establishing the healthcare facility or the minister responsible for health may issue post-inspection recommendations to the manager of the facility, ordering elimination of any irregularities identified.

If, in the course of the inspection, it is found that:

• the statement submitted with the application for entry in the RPWDL was inconsistent with the facts,
• there has been a gross violation of the conditions for conducting medical activities,
• the post-inspection recommendations have not been implemented,

then, following a decision by the authority maintaining the register prohibiting the entity from conducting activities, the entity is removed from the RPWDL. Re-entry is only possible after three years from the date of removal.

The National Health Fund, as an entity financing healthcare services from public funds, is authorized to conduct inspections in particular with regard to:

• the organization and manner of providing healthcare services and their availability,
• the provision of services in terms of compliance with the requirements specified in the contract for the provision of healthcare services,
• the appropriateness of the selection of medicines and medical devices,
• compliance with the rules for issuing prescriptions,
• medical documentation relating to healthcare services financed from public funds.

Based on the inspection, a post-audit report is drawn up, containing an assessment of the activities of the audited service provider and post-audit recommendations in the event of irregularities identified.

MEDICAL PROFESSIONS

Doctor/Dentist

• The right to practice is granted by regional medical councils. On this basis, doctors/dentists are entered into the Central Register of Doctors (CRL) maintained by the Supreme Medical Chamber.
• They are obliged to practice their profession in accordance with current medical knowledge, available diagnostic and therapeutic methods, professional ethics, and with due diligence.
• In the process of diagnosis, treatment, rehabilitation, and prevention, they should be guided by the principles of medical ethics, the standards and guidelines of scientific societies, medical procedures, and the principles of evidence-based medicine (EBM).
• Doctors are obliged to continuously improve their qualifications and professional skills.
• The professional association of physicians and dentists supervises the practice of the profession, including the possibility of revoking the right to practice in the event of serious violations.
• Regional consultants may request that district medical councils carry out quality control of healthcare services.

Feldsher - licenced mid-level medical practitioner

• The right to practice is granted by the Supreme Medical Council.
• On this basis, feldshers are entered into the Central Register of Feldshers, maintained by the Supreme Medical Chamber.
• The profession has been phased out in Poland since 2022.

Nurse/Midwife

• Nurses and midwives are obliged to perform their profession with due diligence, respecting patient rights, and in accordance with the principles of professional ethics and current medical knowledge.
• The right to practice is granted by district councils of nurses and midwives; obtaining it confirms that the required education and qualifications have been met.
• Holders of the right to practice are entered in the Central Register of Nurses and Midwives.
• They are required to continuously update his knowledge and skills.
• Regional nursing consultants may requests that district councils carry out quality control of services provided by nurses and midwives.

Paramedic

• A person who has full legal capacity, is in good health, has sufficient knowledge of the Polish language to perform the job, and has the required education may become a paramedic.
• Another requirement is obtaining the right to practice as a paramedic.
• Paramedics have both the right and obligation to continuously improve their professional skills through various forms of education.
• The Ministry of Health has published a draft regulation on the register of paramedics (May 2025).

Laboratory diagnostician

• Laboratory diagnosticians operating in the form of professional practice are subject to registration in the Register of Entities Performing Medical Activity (RPWDL).
• The National Council of Laboratory Diagnosticians maintains a register of laboratories - entry in this register is a condition for conducting the business.
• The Council also maintains a Register of Sanctioned Laboratory Diagnosticians, which includes persons disciplined by a court of laboratory diagnosticians with, among other things, an admonition, a reprimand, a fine, a ban on holding managerial positions in healthcare units, restrictions on performing certain laboratory activities, and suspension or deprivation of the right to practice.

STATE MEDICAL RESCUE SYSTEM (PRM)

The PRM system provides assistance to any person in a state of health emergency.
It is supervised at the national level by the Minister of Health and at the regional level by the relevant voivode. The system consists of:

• hospital emergency departments (EDs),
• ground medical rescue teams,
• air medical rescue teams.

Health emergencies can be reported by calling 999 or the European emergency number 112.

PHARMACIES AND PHARMACISTS

The requirements for pharmacies as well as the conditions that medicinal products, foodstuffs for particular nutritional uses, and medical devices must meet in order to be marketed in Poland are set out in the relevant legal acts.

Supervision in this area is exercised by:

• President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
• Chief Pharmaceutical Inspector,
• regional Pharmaceutical Inspectorates.

A pharmacy may be operated only on the basis of a pharmacy permit issued by the Regional Pharmaceutical Inspector. He is also competent to amend, revoke or declare the expiry of such permit.

The register of pharmacies is available on the website of the Chief Pharmaceutical Inspector.

The Regional Pharmaceutical Inspector maintains a register of permits to operate:

• public pharmacies,
• pharmacy points,
• hospital and in-house pharmacies,
• hospital pharmacy departments

for entities operating in a given voivodeship.

The right to practice as a pharmacist is granted by the district pharmaceutical council with jurisdiction over the intended place of practice or the Supreme Pharmaceutical Council, which maintains the Central Register of Pharmacists.

MEDICINAL PRODUCTS

The basic quality requirements, methods of testing medicinal products and their packaging, as well as pharmaceutical raw materials, are specified in the Polish Pharmacopoeia, which is fully aligned with the European Pharmacopoeia.
The procedures for registering medicinal products used in Poland – centralized, decentralized, and mutual recognition – comply with European Union standards.

The marketing authorization of a medicinal product in Poland requires a permit from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), except for those products for which the law does not provide for such an obligation. The official list of medicinal products authorized for marketing in Poland is published in a public notice by the President of URPLWMiPB.

Doctors and dentists are required to report all adverse reactions to medicinal products to the responsible entity and the President of URPLWMiPB.

The State Pharmaceutical Inspection supervises:

• the conditions of manufacture and import of medicinal products,
• the manufacture, import, and distribution of active substances,
• the quality of medicinal products,
• their marketing and intermediation in their marketing,
• the marketing of medical devices.

Medicinal products may be purchased at:

• pharmacies,
• pharmacy points,
• non-pharmacy points (only over-the-counter products).

MEDICAL DEVICES

The safety of medical devices is supervised by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), which is responsible for entering information into the European Database on Medical Devices (EUDAMED) concerning:

• devices manufactured by producers based in Poland,
• clinical investigations conducted by them,
• certificates issued by Polish notified bodies.

The Office also conducts inspections of:

• medical device manufacturers,
• authorized representatives, importers and distributors,
• entities assembling devices into systems or procedure packs,
• entities sterilizing devices before placing them on the market,
• subcontractors operating in Poland.

In particular, inspections concern processes related to the design, labelling, storage, distribution, assembly, processing, manufacture, and presentation of products at fairs, exhibitions and scientific symposia.

Medical devices placed on the market must bear the CE marking, which confirms compliance with the requirements of EU legislation. Only custom-made products, including individual medical devices for orthopaedic use, are not required to bear CE the marking.