Poland has in place a system of guidelines for the evaluation of medical devices. The purpose of the guidelines is to indicate principles and acceptable methods for conducting the medical technology assessment process for medical devices, ensuring high quality analysis and reliability of the results.
The guidelines refer to the medical devices applied for in order to be covered by the guaranteed benefit status as defined in art. 15 par. 2 item 14 of the Polish Act on health care services financed from public funds (Journal of Laws 2020, item 1398, as amended), and which are processed in accordance with art. 25 of the Polish Act of 12 May 2011 on reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws 2020, item 357, as amended) and which meet all of the following criteria:
(a) are mass produced;
(b) are intended for use by an individual patient;
(c) are materially superior to products currently receiving public funding, the burden being on the applicant to demonstrate the claimed superiority;
(d) are therapeutic medical devices or are used for prophylaxis (they are not diagnostic medical devices).
When the medical device contains a drug product, the documentation should address the requirements described in the Health Technology Assessment Guidelines (Version 3.0) developed for drug technologies.
Medical device means a tool, apparatus, device, software, implant, reagent, material, or other article intended by the manufacturer to be used, either singly or in combination, in humans for one or more of the following specific medical uses:
– the diagnosis, prevention, monitoring, prediction, prognosis, treatment, or mitigation of disease,
– to diagnose, monitor, treat, mitigate, or compensate for an injury or disability,
– the study, replacement, or modification of an anatomical structure or process or physiological or disease state,
– for providing information through in vitro testing of samples collected from the human body, including those collected from organ, blood, and tissue donors,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on the human body, but whose action may be assisted by such means.
The following products are also considered medical devices:
– devices for the purpose of controlling conception or assisting conception,
– products specifically intended for the cleaning, disinfection or sterilisation of devices.
A medical device for a specific indication constitutes the medical technology being evaluated.
Under current legislation, the placing of LAMs on the market within an EU member state does not have to be preceded by a notification or notification to the Competent Authority, which makes it very difficult to monitor the products currently on the market. The medical device manufacturer must perform an appropriate procedure to ensure that conformity with the essential requirements is assessed. A detailed description of this process in Poland can be found on the website of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish Competent Authority.
In addition, in Poland, if discrepancies arise between the manufacturer and the notified body regarding the classification of a medical device or the qualification of a medical device for in vitro diagnostics, the president of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products resolves them by an administrative decision. If a manufacturer located in Poland or a Notified Body authorized by the Polish Minister of Health erroneously indicate the class of a medical device or misclassify it, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products shall determine the class or qualification of the medical device to be placed on the market or put into use. The following characteristics are considered when classifying medical devices in Poland:
– degree of invasiveness,
– time and type of contact with the patient,
– power supply method,
– the presence of ingredients that are potentially hazardous to the patient (e.g., medicinal products, blood products, animal tissues).
In view of the forthcoming changes in the Polish legislation, which imposes a wide range of tasks on the Medical Technology Assessment And Tarification Agency, it was deemed necessary to collect in one place the guidelines/publications found with a similar scope in order to provide a basis for indicating the challenges ahead, the approaches and the methods used. Guidelines from institutions involved in the marketing and evaluation of medicinal products for reimbursement purposes, descriptions of how medical devices are funded in health systems, and articles from research teams seeking appropriate approaches to medical technology assessment were found.
Guidelines should be based on reliable medical technology assessment methodology, in particular using systematic review methodology where appropriate.
A literature review performed for the MedtecHTA project showed that although generally accepted medical technology assessment standards are good, more attention should be paid to the so-called specific features of medical devices. When assessing comparative clinical effectiveness, it is best to consider procedures involving the use of medical devices as complex (composite) interventions. In contrast, in terms of economic evaluation, changes must be modeled appropriately due to the learning curve, progressive product innovation, and dynamic pricing and organizational impact.
It is worth mentioning that guidelines can be created in two processes: top-down (from general to specific) and bottom-up (from specific to general). When choosing the second one, it is necessary to describe the whole problem with a breakdown into sub-tasks in order to decide which are the most urgent or important to start with.
The broad approach to the subject matter of the guidelines does not mean that they must definitively answer every concern. Rather, it is intended to provide directions for further, more detailed work.