02.06.2010

Medical devices safety technical regulation development

“MEDITEX” Science and Technology Center as associate contractor participated in carrying out a research project “The Russian Federation legal acts regulating medical devices safe handling analysis and proposals formulation on their elaboration”. Under the contract with Ministry of Industry and Trade of the Russian Federation. “MEDITEX” Science and Technology Center was to develop a check list of EU Directives harmonized standards.

Medical devices safe handling regulatory acts that are applicable worldwide and in the Russian Federation were the target of research.

The aim was to analyze regulatory acts that are applicable in Russian Federation and concern medical devices safe handling and to formulate proposals for their improvement. During project accomplishment the following problems were solved: providing regulatory basis for medical devices manufacturers that meet requirements for technical regulations “Medical devices safety”.

Search, identification, analysis and composition of annotated check list of standards harmonized with the following European Union Directives over medical devices regulation were carried out:

№ 93/42 "Medical devices";
№ 98/79 “The In vitro Diagnostic Directive”;
№ 90/385 “The active implantable medical device”.