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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As autonomous cars become an increasingly interesting transport alternative, there will be a growing need for artificial intelligence applications to prevent traffic congestion and accidents. In simplest terms, this could mean that driverless cars will need to communicate and work together. That is why researchers see some promise in preventing both traffic jams and collisions by learning from ants, which are social insects.
What it is and what is the purpose and use of the Ant Colony Optimization?
Ant colony optimisation (ACO) was proposed in the early 1990s by Italian researcher Marco Dorigo. During his PhD thesis, he aimed to search for an optimal path in a graph based on the behaviour of ants searching for a path between the colony and a food source. The basic premise of the ant algorithm is to mimic the behaviour of ant colonies found in the real world. In contrast, their counterparts in digital reality are generated ants that will make limited evaluations of alternative options in the decision-making process. [1] To understand this phenomenon we need to delve into what “swarm intelligence” is. It is actually the collective behavior of any set of decentralized, self-organizing systems that are natural or artificial. It is now commonly used to describe work on artificial intelligence. Swarm intelligence refers to a general set of algorithms. How are such algorithms developed? Based on observations of animal behavior in the wild. This may be direct observation, as was the case in the development of the ant colony optimization algorithm, or it may result from analysis of data from other scientific papers describing the social behavior of selected animal species.[2]
How do we translate this into practice for autonomous cars?
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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.[1] 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
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