On 21.03.2017, a draft regulation of the Minister of Health on the list of medical devices issued on behalf of the Ministry of Health was published. It is intended to replace the Regulation of 6 December 2013 on the list of products issued on request, previously issued on the same basis as the above-called draft, i.e. pursuant to Article 11(2) of Regulation (EC) No 1254/1999. Whereas Article 38 (2) of Regulation (EEC) No 3 4 of the Reimbursement Act.

It should be clarified that the above Regulation of 6 December 2013 was only temporarily maintained until the entry into force of the new implementing rules, but not more than 12 months after the entry into force of the Law of 25 September 2015 on the profession of physiotherapist (as provided for in Article 13of the Law on the profession of physiotherapist). Article 155 of the Physiotherapist Act).

The draft new regulation extends the scope of persons entitled to issue orders for medical devices as part of guaranteed benefits.

The project provides for the power to issue such orders to doctors in the process of specialisation. According to another regulation , 'on guaranteed outpatient specialist care services', doctors are fully entitled to provide guaranteed services during their specialisation. In order to maintain consistency and compliance with the current Regulation, the draft provides that when a list refers to an authorised doctor of a particular specialisation, it should also be understood as a doctor who is in the process of specialising in this field.

For some medical devices, m.in orthopaedic orthopaedic corsets have been extended to include doctors of certain specializations. The list of entities entitled to nurses and midwives has also been supplemented, which is lacking in the current regulation. Physiotherapists are also included in the list, granting them powers over physiotherapy-related medical devices.

The project expands the list of medical devices with two new products: "transmitter-transmitter" and "sensor/electrode". They are to be used in the new guaranteed "Real-Time Glycaemic Monitoring System (CGM – RT), which is added to the scope of outpatient specialist care. Children up to the age of 18 with type I diabetes have to use these devices.

The possibility of shortening the useful life of children's wheelchairs in medically justified cases has also been introduced. The Regulation shall enter into force on the day following the announcement.

The project is available at: http://legislacja.rcl.gov.pl/docs//516/12296551/12421745/12421746/dokument280497.pdf

Author: Marcin Rytel – KONDRAT Law Firm and Partners

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