EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

Research and Innovation in Exploration and Mining of Raw Materials: The ROBOMINERS Project

ROBOMINERS is a new project funded under the European Union’s Research and Innovation Programme Horizon 2020, which aims at employing a bio-inspired robot, focused on the prospect of mineral exploration and extraction within Europe. ROBOMINERS’ innovative approach combines the creation of a new mining ecosystem through the development of a bioinspired robotic miner prototype, able to explore and mine mineral deposits which are currently considered uneconomic due to their small size and difficulty of access. The main objectives of the project include the creation of a European database of potentially suitable locations for the deployment of this novel technology. The building of the pan-EU mineral deposits database is considered vital for the development of the project as it will provide essential information related to deposit type and commodities, spatial and temporal distribution, and location of exploration targets. Several deposits have been reviewed and examined in Greece as potential targets suitable for the ROBOMINERS technology, after considering the specific restrictions and requirements of the project. The main targets have been determined and arranged according to the different aspects required by the applicability of the ROBOMINERS innovative technology.

Corneal Biomechanics Computational Analysis for Keratoconus Diagnosis

For machine learning techniques to be used in early keratoconus diagnosis, researchers aimed to find and model representations of corneal biomechanical characteristics from exam images generated by the Corvis ST. Image segments were used to identify and convert anterior data into vectors for representation and representation of apparent posterior surfaces, apparent pachymetry, and the composition of apparent anterior data in images. Chained (batch images) and simplified with wavelet, the vectors were also arranged as 2D histograms for deep learning use in a neural network. An interval of 0.7843 to 1 and a significance level of 0.0157 were used in the scoring, with the classifications getting points for being as sensitive as they could be while also being as precise as they could be. In order to train and validate the used data from examination bases in Europe and Iraq, in grades I to IV, researchers looked at data from 686 healthy eyes and 406 keratoconus-afflicted eyes. With a score of 0.8247, sensitivity of 89.49%, and specificity of 92.09%, the European database found that apparent pachymetry from batch images applied with level 4 wavelet and processed quickly had the highest accuracy. This is a 2D histogram of apparent pachymetry with a score of 0.8361, which indicates that it is 88.58 percent sensitive and 94.389% specific. According to the findings, keratoconus can be diagnosed using biomechanical models.

Opening New Markets for Your Private Practice Business and Manufacturing in Oral Surgery Needs

A little competition is a good thing and severe competition is a blessing. Thank God for competition. —Jacob Kindleberger Germany-borned United States mill owner Oral surgery and dentistry are highly competitive fields. Competition among private practices in Ukraine is intensifying. Moreover, according to the 2016 data, 3,734 private dental/stomatological clinics (offices) were registered in this country.1,2 And this despite the fact that the first private clinics in modern Ukraine start to appear only in 1991, the year of independence after the collapse of the Soviet Union. That is, we can assume that the market of private clinics for 25 years in Ukraine has grown by phenomenal 3,734 percent. At the same time, there is a tendency towards a decrease in the number of state stomatological policlinics what is also a part of the field`s evolution.1,2 The interesting thing we should understand is that some of private clinics and their owners can compete not only in the treatment process, but also as manufacturers and sellers of the products for dentistry/oral surgery. Previously, only a CE marking (CE abbreviation of Conformité Européenne [in French] mean European Conformity) and a dealer's office were required to operate in the EU market, but now, due to the reformatting of the legislation, it is necessary to have an authorized representative. Such companies` sectors as U-Represent3 can help Ukrainian manufacturers in uncomplicated and inexpensive way to reach European Union and Switzerland markets. The services of U-Represent are: 1) Pre-audit document review, 2) conformation of documents, 3) archive and storage location, 4) products registration in European database on medical devices (EUDAMED), 5) post-market surveillance monitoring, etc.3 Thus, with authorized representatives, who are doctors with PhD and certified ISO (ie, the International Organization for Standardization) professionals, your dental business and manufacturing can hold a strong position not only on domestic market but also to take a share in the growing European and Switzerland marketplaces.

Density assessment and reporting for Phlebotomus perniciosus and other sand fly species in periurban residential estates in Spain

Green periurban residential areas in Mediterranean countries have flourished in the last decades and become foci for leishmaniasis. To remedy the absence of information on vector ecology in these environments, we examined phlebotomine sand fly distribution in 29 sites in Murcia City over a 3-year period, including the plots of 20 detached houses and nine non-urbanized sites nearby. We collected 5,066 specimens from five species using “sticky” interception and light attraction traps. The relative frequency of the main Leishmania infantum vector Phlebotomus perniciosus in these traps was 32% and 63%, respectively. Sand fly density was widely variable spatially and temporally and greatest in non-urbanized sites, particularly in caves and abandoned buildings close to domestic animal holdings. Phlebotomus perniciosus density in house plots was positively correlated with those in non-urbanized sites, greatest in larger properties with extensive vegetation and non-permanently lived, but not associated to dog presence or a history of canine leishmaniasis. Within house plots, sand fly density was highest in traps closest to walls. Furthermore, the study provides a guideline for insect density assessment and reporting and is envisioned as a building block towards the development of a pan-European database for robust investigation of environmental determinants of sand fly distribution.

The ROBOMINERS project: a promising tool for the re-evaluation of “non-economical” deposits. Aiming at the development of a joined European database of potentially suitable ore deposits for the utilization of the Robominers technology.

<p>The ROBOMINERS (Resilient Bio-inspired Modular Robotic Miner) project aims at developing new methods and technologies (prototype automation and robotics technology) to locate and exploit underground mineral deposits and is funded under the European Union’s Research and Innovation programme Horizon 2020. The project targets mineral deposits that are generally considered “non-economical” either because they are not accessible anymore for conventional mining techniques, or they have been previously explored but exploitation was considered uneconomic due to the small size of the deposits or the difficulty to access them (abandoned, small, ultra-depth deposits).</p><p> </p><p>The European Federation of Geologists (EFG) is part of the Robominers consortium and its role includes the collection of publicly available data at a national level on mineral deposits which are potential targets on the developed mining technology. The Association of Greek Geologists (AGG) is participating as an EFG Linked Third Party in the project aiming, among others, at the creation of a European database of potentially suitable ore deposits for the utilization of the Robominers technology.</p><p> </p><p>The creation of an ore deposits’ European database is a crucial procedure for the best possible design of exploration and exploitation applying the Robominers innovative approach. The AGG has contributed in the building of a database at a national level (for Greece), of the major and most important mineral deposits, according to the project requirements. A number of ore deposits in which Robominers advanced technology may provide a unique solution to mineral extraction, include porphyry and epithermal deposits and especially vein-like types, but volcanogenic massive sulphide (VMS-type) and lense-like or layered orthomagmatic deposits can also be of high importance. From the above mentioned ore deposits the most abundant in Greece are epithermal deposits, deposits in hydrothermal veins, porphyry copper, as well as chromites in ophiolite complexes. Regarding the spatial distribution vein-type or metasomatic deposits are located mostly in Northern Greece (Western Macedonia and Thrace regions) while significant variable-mineralization deposits are related with the Attico-Cycladic belt volcanism (mainly Lavrion, Evia, and islands in the Aegean Sea). Finally, PGE bearing chromite deposits and bauxite deposits, located mainly in Central Greece, may also be significant for the project.</p><p> </p><p>The establishment of a joined European Robominers database is of great significance for the progress of the project since it will provide essential information on key outputs such as the deposit type and commodities, the host rock, and the spatial distribution of the project’s targeted ore deposits and will provide valuable knowledge regarding the future planning of the exploration and exploitation from the developed Robominers innovative technology approach.</p><p>Dr Eleni Koutsopoulou</p><p>Coordinator of the project</p><p>On Behalf of the:</p><p>Association of Greek Geologists</p><p>Didotou 26,10680, Athens, Greece</p><p>VAT ID: EL-999600130</p><p> </p><p> </p>

Defining potential multi-hazard and multi-risk combinations for infrastructure and other economic sectors using empirical pan-European examples

<p>A new complex world is emerging where a natural hazards event in a certain location, can have significant impacts on a different location either interlinked via economic sectors, infrastructure systems or other social relationships. In the past this was often not able to be quantified, but with increased reporting we are able to define these interactions better than previously.</p><p>For a single location, multiple hazards can also occur in tandem, or one after another causing impacts or as a standalone. However, standalone events currently take on a whole new complexity with coronavirus protocols.</p><p>Within the course of the EU project NARSIS (New Approach to Reactor Safety ImprovementS), sites of decommissioned nuclear power plants (NPPs) were investigated for external hazards combinations using a multi-hazard approach which took into account the joint probabilities including operational times and the effects of subsequent events. Here, different external hazards were applied such as tornadoes, lightning, earthquakes, floods and volcanic eruptions in tandem calibrated on historical events.</p><p>In this work, we build a pan-European database using the backbone of CATDAT to define multi-hazard events of relevance with overlapping hazard and loss effects including events in 2020 and 2021 with significant effects due to coronavirus in combination with another hazard. We focus on the 1980-2021 time period within this database, although many older events have also been collected.</p><p>In the year 2020, numerous events including the Croatian and Greece/Turkey earthquakes, medicanes, bushfires and many flood and storm events showed the complexity of combining multi-hazard protocols concurrently.</p><p>The database will be extended within the MYRIAD-EU project in order to inform a multi-risk, multi-sector, systemic approach to risk management. Using empirical examples of socio-economic effects is one key step to understand the overlaps, and important within the calibration process of any multi-risk model.</p>