Κατεύθυνση Σχεδιασμός και Διοίκηση Υπηρεσιών Υγείας
Library of the School of Health Sciences

2020-12-02

2020

Kazouri Sofia

Μαρία Καντζανού, Επίκουρη Καθηγήτρια Ιατρικής, ΕΚΠΑ
Γιάννης Τούντας, Καθηγητής Ιατρικής, ΕΚΠΑ
Βασιλική Μπενέτου, Αναπληρώτρια Καθηγήτρια Ιατρικής ,ΕΚΠΑ

Oργάνωση και σχεδιασμός φορέων πιστοποίησης ιατροτεχνολογικών προϊόντων

Greek

Οrganization and design of medical technological certification bodies

Introduction: Medical technology products are an area of increased importance in terms of their health effects. Legislative, regulatory and administrative provisions, which have been in force in the Member States in the past, regarding the safety and health characteristics, performance and certification and control procedures of medical technology products differed from one Member State to another, resulting in These discrepancies are barriers to trade within the Community.

Purpose: The purpose of this paper is to highlight the organization and design of certification bodies for medical technology products as well as the need that arises for the existence of an authority that will undertake the information of individuals in order to know what they provide and if it meets the requirements.

Material - Method: Greek and foreign language books and articles from databases such as Google Scholar and official online sources were used.

Conclusions: Thus, the Community's initiative to regulate this sector was deemed necessary. Over time and with the development of the regulatory framework, immediate benefits have been provided for patients across the EU (European Union), as it has become clear that quality, safety, performance and clinical evaluation standards for medical technology products have improved. which increased patient safety and health.

Health Sciences

Certification, Medical Technologies, Quality Standards, European Regulation

No

0

No

29

80

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https://pergamos.lib.uoa.gr/uoa/dl/object/2926430