Amendments to the implementation of contracts such as the provision of medical devices

On March 26, 2021, the NFZ published Order No. 52/2021/DSOZ amending the Order on the conditions for concluding and implementing contracts such as medical device supply services.

Content of the order:


This order by the President of the National Health Fund amends the order on the conditions for concluding and implementing contracts such as the provision of medical devices, implementing the authorisation contained in Article 10. Whereas Article 159 (1) of the Treaty provides that the Community may adopt measures 2 of the Act of 27 August 2004 on publicly funded health care benefits (OJ 2020, item 2020). 1398, as amended. as amended).

The amendments introduced by this Order are conditional on the inclusion in the Integrated Qualifications System of a new market qualification "Supplying in stores with serially manufactured medical devices" on the basis of the Notice of the Minister of Health of 19 December 2018 on the inclusion of the market qualification "Supplying in stores with mass-produced medical devices" in the Integrated Qualifications System (OJ C 133, 11.12.2018, p. 1). Office of The Min. Zdr. of 2018 item. 1269).

The document confirming the award of the afored qualification is a certificate obtained by methods of validation in the form of a theoretical test and observations under simulated and real conditions in terms of knowledge of general human construction, characteristics of the medical device, current legal regulations, implementation of the process of sale of medical devices, execution of commissioning and preparation of accompanying documentation, preparation of financial and settlement documentation with the NFZ.

On 8 October 2020 The Minister of Health has signed an agreement with the Medical Center of Postgraduate Education based in Warsaw, conferring the authority to act as an External Quality Assurance Entity. The certification body for qualifications is the National Chamber of Commerce of Medical Devices POLMED, which from 4 December 2019 has full powers to certify and validate qualifications.

Accordingly, Annex 7 to the Order laying down the conditions for the provision of the services covered by the contract, such as the supply of medical devices including the scope of the activities performed and the qualifications required of the persons providing those services, has been amended.

The draft order of the President of the National Health Fund, in accordance with Article 146(1) of the Treaty, shall be adopted in accordance with the procedure laid down in Article 18. 4 of the Benefits Act and in accordance with § 2 para. Article 3 of the Annex to the Regulation of the Minister of Health of 8 September 2015 on the general terms and conditions of contracts for the provision of health care services (OJ C 104, 11.12.2015, p. 1). U. 2020 item 320, as amended. has been subject to external consultation for a period of 14 days. As part of the public consultation, the draft was submitted for opinion to the competent entities: national consultants in the relevant field of medicine, professional self-government (General Medical Council, General Council of Nurses and Midwives, National Council of Physiotherapists). Five entities took the position without commenting on the draft order.

Comments on the draft order were submitted by four Regional Branches of the NFZ, some of which were taken into account.

These actions have been undertaken in the framework of the implementation of Objective 2 of the National Health Fund Strategy 2019-2023 on improving the quality and accessibility of healthcare services.




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