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Publisher: Peytchinski, Gospodin Iliev
ISSN: 1312 773X (Online)
Issue: 2015, vol. 21, issue 1
Subject Area: Medical Legal Regulations
Pages: 709-712
DOI: 10.5272/jimab.2015211.709
Published online:13 February 2015
J of IMAB 2015 Jan-Mar;21(1):709-712
BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.
Maya Lyapina1
, Mariela Yaneva-Deliverska2, Jordan Deliversky3, Angelina Kisselova4.
1) Department of Hygiene, Medical Ecology and Nutrition, Medical University, Medical Faculty, Sofia, Bulgaria
2) Legal Department, Military Medical Academy, Sofia, Bulgaria
3) Department of National Security, State University of Library Studies and Information Technologies, Sofia, Bulgaria
4) Department of Oral and Image Diagnostic, Faculty of Dental Medicine, Medical University - Sofia, Bulgaria.
ABSTRACT:
Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD), or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.
Key words: medical devices, borderline cases, classification cases, EU, dentistry products,
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Please cite this article in PubMed Style or AMA (American Medical Association) Style:
Lyapina M, Yaneva-Deliverska M, Deliversky J, Kisselova A. Borderline and classification in the community regulatory framework for medical devices – brief review on some dentistry products. J of IMAB. 2015 Jan-Mar;21(1):709-712. doi: http://dx.doi.org/10.5272/jimab.2015211.709
Correspondence to: Dr. Maya Lyapina, Department of Hygiene, medical ecology and nutrition, Medical Faculty, Medical University, Sofia; 15, Acad. Ivan Geshov blvd., 1431 Sofia, Bulgaria; E-mail: saly_grigory@abv.bg
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Received: 05 December 2014
Published online: 13 February 2015