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.
DEFINITION OF MEDICAL DEVICES AND MEDICAL TECHNOLOGY ASSESSMENT UNDER POLISH LAW
KIELTYKA GLADKOWSKI KG LEGAL is heavily involved in complex assistance to clients operating in clinical trials sector and it diligently observes the market in this respect within new technologies used in clinical trials. In 2020 there have been noted considerable challenges for the science and technology, including technologies in clinical trials. The pressure that has been placed on the healthcare systems turned out to be unprecedented. The rapid spread of coronavirus has lead to the global debate on the reassessment of the approach to clinical trial conduct. Previously, it was believed that the driving force of medicine development is technology.
Remote clinical trials: a new standard
In March 2020 biopharmaceutical companies managed to conduct more than 9,000 clinical trials in the U.S. However, the pandemic outburst has brought the future biopharma development into a question. Nevertheless, some researchers decided to take the advantage of the wide range of available information and communication technology devices. Combining novel tactics like mailing medications and relying on digital technologies such as transmitting photos of home-based blood pressure readings via text message has resulted in remote clinical trials. At this point, it is fundamental to stress the surprising advantages of clinical trials conducted remotely, which are:
- personalizing and strengthening patient engagement,
- accelerating recruitment (recruiting more people and more quickly than with a local study),
- improving patient diversity and data quality (reaching greater geographic area and patients of different ethnic background, providing more comprehensive patient monitoring),
- accelerating time to market.
Wearable technologies in remote clinical trials
In order to ensure the greatest possible safety for the patient, the manufacturer must notify and register the medical device before placing it on the market. However, before this can happen, a number of conditions must be met. On 26 May 2021, the revision of EU medical device legislation came into force. These regulations are governed by Regulation 2017/745 of the EU Parliament and Council of 5 April 2017 (MDR Regulation) on medical devices. In Poland, the register of medical devices placed on the market or put into use and the entities responsible for their introduction is kept by the Polish President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
What is a medical device?
Under Polish law, in accordance with Article 2 of the Act on Medical Devices of 20 May 2010, a medical device is: “an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by its manufacturer to be used for human beings with a view to
- the diagnosis, prevention, monitoring, treatment or alleviation of disease,
- to diagnose, monitor, treat, alleviate or compensate for the effects of an injury or handicap,
- studying, replacing or modifying an anatomical structure or a physiological process,
- regulation of conception” 
What EUDAMED database is?
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnosis medical devices. The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).
EUDAMED is the unified European medical products database. EUDAMED aims to improve transparency and coordination of information on medical devices available on the EU market.
How does it work?
EUDAMED is structured around 6 interconnected modules and a public website:
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
One can search for medical products by manufacturer, by package number, by authorized representative, by importer and by barcode on the UDI packaging and by certificates. Every medical product listed there is sold throughout the Europe.
The COVID-19 pandemic significantly accelerated the adoption of decentralized clinical trials. As health system resources were expended on COVID-19-related care and travel became limited by physical distance, patient access to research facilities decreased by 80 percent. In the face of such disruptions, sponsors quickly mobilized to maintain continuity of care and data integrity – for example, by adopting remote patient consent and monitoring. Although some elements of decentralization of clinical trials existed before the COVID-19 pandemic, they were not widely used in trials. And as the global pandemic continues, a consensus is emerging that many interventions will become permanent. Tools such as electronic consent, telehealth care, remote patient monitoring, and electronic clinical outcome assessments (eCOAs) make it possible to maintain contact with study participants without in-person visits.
Defining decentralized clinical trials and trying to understand them