Unit:
Κατεύθυνση Κλινικές Μελέτες: Σχεδιασμός και ΕκτέλεσηLibrary of the School of Health Sciences
Supervisors info:
Μιχαήλ Λιόντος, Επίκουρος Καθηγητής, Ιατρική Σχολή, Εθνικό Καποδιστριακό Πανεπιστήμιο Αθηνών
Ευάγγελος Τέρπος, Καθηγητής, Ιατρική Σχολή, Εθνικό Καποδιστριακό Πανεπιστήμιο Αθηνών
Ουρανία Τσιτσιλώνη, Καθηγήτρια, Τμήμα Βιολογίας, Εθνικό Καποδιστριακό Πανεπιστήμιο Αθηνών
Original Title:
Ιατροτεχνολογικά προϊόντα και τα κλινικά τους στάδια
Translated title:
Medical devices and their clinical stages
Summary:
In the context of this thesis, we will try to analyze, as thoroughly as possible, the rationale behind regulations and clinical research on medical devices. In particular, we are dealing specifically with medical devices, without referring in depth to in vitro diagnostic products or implantable medical technological products, which are a separate, special category of medical technological products that could be analyzed in another future thesis.
The European Union rules on the safety and performance of medical devices were created in the 1990s. In order to reflect the significant technological and scientific progress in this area over the last 20 years, the Commission proposed to renew the rules to improve safety of medical devices, with the aim of modernizing the sector and consolidating the role of the European Union as a world leader in this field.
The new Regulation 2017/745 (MDR) of the European Union that was established, will gradually replace both previous Directives in force (93/42/EEC and 90/385/EEC) and their harmonization with our country's legislation. The new Regulation comes into force from 26 May 2021, with an adjustment period to avoid market disruptions, while several transitional provisions will apply until 2025. The Regulation covers a wide range of responsibilities, such as those of the manufacturer, distributor, vigilance and others. The most important changes have to do with:
-the Notified Bodies which must be defined under the new Regulation.
-the manufactures who have to meet stricter criteria, particularly in terms of clinical evaluation and performance evaluation of medical devices. At this point, it worths to be mentioned that due to the reclassification of medical devices, it is necessary to re-certify the devices according to new clinical data.
-clinical studies where the manufacturers deposit and evaluate a clinical investigation plan (CIP) to determine the general safety and performance requirements of the investigational medical device.
Therefore, through a collective effort to create and implement the new Regulation that concerns the management of all categories of medical technology products, we seek to ensure a high level of public health and above all patient safety, taking into account scientific progress.
Main subject category:
Health Sciences
Keywords:
Medical devices, European Regulation Medical devices MDR, Notified Bodies, Manufactures, Classification, EUDAMED, Clinical trials
File:
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Vourlou_Anna_MSc.pdf.pdf
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