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
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On 5 October 2020 the EU’s law enforcement agency, Europol has published a new report – The Internet Organised Crime Threat Assessment (IOCTA) 2020. The report includes information about the latest developments with regard to cross-cutting crime facilitation. It also treats about the challenges related to criminal investigations, cyber-dependent crime, online child sexual exploitation, payment fraud and criminal abuse via the dark web.
The report shows that technological developments make it easier to commit cybercrime. Many modern financial instruments such as cryptocurrencies, for example, make it possible to pay for various forms of crime online. Recently the key trend seems to be sim-swapping.
What is sim-swapping?
Sim-swapping is a cybercrime. This is a type of account takeover fraud that generally targets a weakness in two-factor authentication and two-step verification in which the second factor or step is a text message (SMS) or call placed to a mobile telephone.
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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” [1]
MDR Regulation
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What is e-cigarette? Legal definition by describing the functionality of the device
In accordance with the Polish Act of 22 July 2016 amending the Polish Act on Health Protection from the Effects of Tobacco and Tobacco Products, electronical cigarette is a device that can be used to ingest nicotine-containing vapor via a mouthpiece, or all components of that device, including cartridges, tanks and devices without a cartridge or tank. Electronic cigarettes may be disposable or refillable with a refillable cartridge or tank or rechargeable with a disposable cartridge.onet
The amended definition of “tobacco product” in Art. 2(48) of the Act, however, does not allow for an electronic cigarette to be considered a tobacco product. In the current wording of the Act, a tobacco product is a product intended for consumption by consumers and composed, even in part, of tobacco, including genetically modified tobacco. Importantly, the definition of ‘tobacco’ in Art. 2(36) of the Act unambiguously defines it as leaves or other natural parts of plants, excluding from the scope of this concept extracts used in e-cigarettes.
E-cigarettes cannot be classified as tobacco products within the meaning of Art. 2 (48) and should therefore be referred to as other regulated products. This position is reflected in the provisions of the act in question, which in many provisions clearly distinguish tobacco products from electronic cigarettes, while introducing similar restrictions on marketing or use of both types of products.
Bringing in regulations on e-cigarettes
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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.
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