What are medical devices?
Medical devices are a very wide range of products. They range from wheelchairs, prostheses, wigs, dressings, venous cannulas, absorbent devices, syringes to complex equipment such as MRIs and CT scanners. From the patient's perspective, medical devices are most easily divided into those for individual supply available in medical shops and pharmacies (absorbents, wheelchairs,.), prescription medical devices (dressings, blood glucose strips) and devices used in hospital services, purchased by hospitals (MRIs, scalpels, heart valves, etc.).
Under what rules are medical devices for individual supply (issued on prescription) currently funded?
Under health insurance, the patient is entitled to funding for medical devices from a list of product types defined by the Minister of Health (e.g. wigs, catheters, wheelchairs, absorbents, etc.). In order to benefit from the funding, the patient must:
- obtain an order from a doctor for the supply of a medical device;
- visit a selected facility (e.g. a medical shop with a contract with the National Health Service or a pharmacy), where he or she can select and fit a specific device from a range of manufacturers;
The current list of prescribed medical devices specifies which groups of devices are financed by the NHF with what frequency and price limit. If the price of a given device chosen by the patient exceeds the limit specified in the list - the patient pays the difference between the gross price and the reimbursement amount. The amount of reimbursement and the patient's contribution depends, among other things, on the type of condition.
NOTE: The assessment of disability affects both the amount, frequency and extent of the limits due.
Other ways of financing medical devices:
In addition to prescription devices, there are also funded/reimbursed devices in the system:
- as part of other guaranteed benefits, as part of these benefits - e.g. hospital benefits (in the course of a patient's visit to hospital, various devices are used - e.g. gloves, syringes, bandages, gauze pads, the cost of which is covered by the NHF);
- by filling a reimbursement prescription (just like reimbursed medicines) - currently, this reimbursement method only applies to two categories of products - specialist dressings and blood glucose meter strips.
Where can medical devices be purchased?
The most basic medical devices can be purchased at virtually any general shop (e.g. plasters or condoms). More advanced products can be bought in specialised medical shops or pharmacies. However, in pharmacies, the range is most often limited to minor products such as absorbents, thermometers or eye drops and orthopaedic supplies (e.g. wheelchairs, crutches, orthoses, etc.) are usually not available for purchase.
How should a medical device be labelled?
The medical device should be labelled and have instructions for use in Polish or expressed by harmonised symbols or recognisable codes. All information should be provided in such a way that it is understandable to the patient.
The most essential element in the labelling of a medical device is the so-called 'mark'. 
which, when affixed to a device, confirms that the product has undergone the relevant conformity assessment procedures and has been found by the manufacturer to comply with EU law. Every medical device must be CE-marked.
How do you recognise the right product that is a medical device?
Any tool, instrument, device, material or other article intended for use in humans for medical purposes - e.g. diagnosis, monitoring or treatment of an illness or injury - is a medical device. An exception to the above rule is products that achieve their effects by pharmacological means - i.e. medicines. If a product is not a drug and is intended by the manufacturer to be used for a medical purpose (e.g. a wound dressing, a thermometer for monitoring body temperature), it is almost certainly a medical device.
Some medical devices can also be identified by the information on their packaging or label - if the label shows the symbol
, then we can be sure that the product in question is a medical device. However, this is not the rule and not all medical devices have this designation.
What documentation should accompany it?
No specialised documentation needs to be provided with the medical device. All information necessary for the safe and appropriate use of the medical device should be included on its label and in the instructions for use. Exceptionally, simple-to-use medical devices with a low risk profile do not even need to have separate instructions for use if they can be used safely without instructions.
Possible additional sources of funding (e.g. PFRON, PCPR) in addition to NFZ funding
Some insured persons, in particular those with a disability certificate, can, in addition to NFZ funding, also benefit from subsidies (in addition to this reimbursement) from the State Fund for the Rehabilitation of the Disabled, which are distributed by District Family Assistance Centres and are entitled to the following depending on various criteria:
- funding up to the NFZ limit, according to the guidelines a maximum of 150% of the NFZ limit can be granted (most recently it has been granted in the amount of 100%), criteria: having a disability certificate and an income criterion, broken down into two ceilings: for persons living alone (up to 65% of average salary) or jointly in a household (up to 50% of average salary per person), according to current CSO indicators, a copy of the NFZ order must also be attached to the application - permanent/annual subsidy system, applications considered by committee, cyclically;
- subsidies for rehabilitation equipment not covered by health insurance, but recommended by a doctor (without the possibility of issuing a NFZ application) are regulated separately from subsidies for the purchase of medical devices on prescription and the maximum subsidy amount is 80% of the costs incurred, but no more than five times the average wage - permanent/annual subsidy system, applications considered by a committee, cyclically;
- subsidy programme (not refinancing - you can't "pre-pay the money and claim it back") for vocational activation "Aktywny Samorząd" for people who are economically active or want to take up employment who are of working age, objective: elimination of barriers limiting social and professional functioning of persons with disabilities, required to have a disability certificate, no income criterion, requirement of own contribution in the amount of 10% to 25%coin of the total cost of a given supply, granted general limits set by the Programme guidelines, However, with the possibility of granting more funds depending on the individual situation, its justification and the cost of purchasing the product, subsidy system on an annual basis (applications considered once a year), applications can be submitted from 1 March to 31 August in the preferred electronic mode (additional points for this mode are to be an incentive);
- Programme to subsidise the elimination of technical and communication barriers (not to be confused with architectural barriers - it is not possible to "prepay the funds and claim them back") for persons with a disability certificate, maximum of 95% of the costs incurred, but no more than 15 times the average salary, disability certificate required, no income criterion, important is the content of the justification submitted with the application, year-round system, applications considered by committee/cyclically;
- and, of course, the whole system of support from various foundations or associations considered on a case-by-case basis, most often also dependent on having a disability certificate - largely discretionary, not uniform, with no fixed guidelines.
Material for the Institute for Patients' Rights and Health Education as part of the Network for Health project was prepared by a team of experts Polish Chamber of Commerce of Medical Devices "POLMED"
The Network for Health project is implemented with a grant from the Active Citizens Programme - National Fund financed by Iceland, Liechtenstein and Norway through the EEA Funds.. .