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Publisher: Peytchinski, Gospodin Iliev
ISSN: 1312 773X (Online)
Issue: 2015, vol. 21, issue 1
Subject Area: Medical Legal Regulations
Pages: 705-708
DOI: 10.5272/jimab.2015211.705
Published online:13 February 2015
J of IMAB 2015 Jan-Mar;21(1):705-708
BIOCOMPATIBILITY OF MEDICAL DEVICES – LEGAL REGULATIONS IN THE EUROPEAN UNION.
Mariela Yaneva-Deliverska1
, Jordan Deliversky2, Maya Lyapina3.
1) Legal Department, Military Medical Academy, Sofia, Bulgaria
2) Department of National Security, State University of Library Studies and Information Technologies, Sofia, Bulgaria
3) Department of Hygiene, Medical Ecology and Nutrition, Medical University, Medical Faculty, Sofia, Bulgaria.
ABSTRACT:
A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. Therefore, legal regulations do not release the specialists in the fields of medicine and dentistry from the responsibility to gather as much information as possible about the products used or to request this information from the manufacturer. Safety data sheets for medical devices can be downloaded from the Internet. They are an important source of information about the biocompatibility of dental materials as they were investigated by the manufacturers. Appropriate safety labels on the wrappings should be considered. The manufacturer/importer is responsible for its products and is potentially liable for damages. The medical doctors and dentists should use only those medical devices for which appropriate information is available..
Key words: legal regulations, European Union, medical devices,
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Please cite this article in PubMed Style or AMA (American Medical Association) Style:
Yaneva-Deliverska M, Deliversky J, Lyapina M. Biocompatibility of medical devices – legal regulations in the European Union. J of IMAB. 2015 Jan-Mar;21(1):705-708. doi: http://dx.doi.org/10.5272/jimab.2015211.705
Correspondence to: Dr. Mariela Yaneva-Deliverska, Legal Department, Military Medical Academy, Sofia; 3, St Georgy Sofiiski blvd., 1606 Sofia, Bulgaria; E-mail: yanevamariela@yahoo.com
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Received: 05 December 2014
Published online: 13 February 2015