European certification

Our partners

International Medical Devices Certification Centre EUROCERT was found in 2002 with the purpose to help domestic manufacturers in getting European certificates for their medical products in Russia and in selling their medical products in the European Community.

The participants of EUROCERT are:

• GOSSTANDART of Russia (now as Federal Agency on Technical Regulating and Metrology);
• Certification Centre of Medical Equipment VNIIMP, Russia;
• Institute for Certification and Testing EUROCAT, Germany.

Institute for Certification and Testing EUROCAT has been accredited to carry out the certification of companies and products in accordance with DIN EN ISO 9001:2000, DIN EN ISO 13485:2003, Medical Device Directive 93/42/EEC, In-vitro Diagnostic Devices Directive 98/79/EC, Active Implantable Medical Devices Directive 90/385/EEC. European identification number of EUROCAT is 0535. If you have an EUROCAT certificate for your products, you can bear the CE-marking of conformity on them.

Please, do not hesitate to contact us by phone +7 (495) 611-17-00 if you have any questions. Contact persons: Stepanov Vitaliy Nikolaevich, the head of Quality department, Mashkov Aleksander Vladimirovich, the director. Also you could make a request/order a service at our website item “Make a request”.

Certification of medical devices, the CE-marking

Medical devices must meet the essential requirements of the European Community (EC) before they are placed on the EC-market.

These requirements are determined in the following directives:

• Medical Device Directive 93/42/EEC;
• Active Implantable Medical Devices Directive 90/385/EEC;
• In-vitro Diagnostic Devices Directive 98/79/EC.

Medical devices, considered to meet the essential requirements of the Directives, must bear the CE-marking of conformity when they are placed on the EC-market. The CE-marking of conformity is welcomed in Latin America, Africa andSouth-East Asia.

You might certify your medical devices in accordance with the requirements of European Directives at our partner, Institute for Certification and Testing EUROCAT, Germany. European identification number of EUROCAT is 0535.

If you are interested in certification of your medical devices in accordance with the requirements of the European Directives, please, fill in The application for medical devices certification (CE-marking) and send it by e-mail amashkov@mtu-net.ru. Institute for Certification and Testing EUROCAT will review your information, make a business offer for your company and define the cost, terms and conditions of the certification process. According to the requirements of the European Directives an organization shall establish and maintain a set of technical documentation for each type or model of medical device. The contents of a set of technical documentation, please, look up in Information on technical documentation concerning medical devices.

Please, do not hesitate to contact us by phone +7 (495) 611-17-00, 611-17-38 or by e-mail amashkov@mtu-net.ru if you have any questions. Contact persons: Stepanov Vitaliy Nikolaevich, the head of Quality department, Mashkov Aleksander Vladimirovich, the director. Also you could make a request/order a consultancy at our website item “Make a request”. 

Certification of quality management systems in accordance with ISO 9001, ISO 13485

The implementation of quality management system (QMS) plays a major role in ensuring of release of qualitative and safe products with high operating characteristics. The majority of companies in the European Community (EC) have implemented and certified quality management systems throughout their organizations. The certified quality management system is one of the great competitive advantages of Russian manufacturers, if they are going to place their medical products on the EC-market. Depending on the medical device classification there are several conformity assessment procedures that can be applied for the certification in accordance with the European directives. Most of conformity assessment procedures include quality management system certification at an organization in accordance with European standards. Certification of quality management systems might be conducted in accordance with the International Standards ISO 9001:2000 and ISO 13485:2003. ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. The application of the standard ISO 13485 is sufficient for organizations that produce medical devices only. This International Standard is a stand-alone standard.

If quality management system has been implemented in a company, a certification organization checks and assesses this system and confirms that a company, with the help of the quality management system, is able to assess the product conformity with the determined requirements and to maintain this conformity.

If you are interested in certification of your quality management system in accordance with the ISO 9001:2000 and/or ISO 13485:2003, please, fill in The application for QMS-certification (EC) and send it by e-mail amashkov@mtu-net.ru. Institute for Certification and Testing EUROCAT will review your information, make a business offer for your company and define the cost, terms and conditions of the certification process.

Please, do not hesitate to contact us by phone +7 (495) 611-17-00, 611-17-38 or by e-mail amashkov@mtu-net.ru if you have any questions. Contact persons: Stepanov Vitaliy Nikolaevich, the head of Quality department, Mashkov Aleksander Vladimirovich, the director. Also you could make a request/order a certification service at our website item “Make a request”.