Medical devices (ISO 13485)

Technical Regulations of Ukraine indicate the mandatory presence of the implemented quality management system (QMS) in the production. Such requirements of the national legislation in the field of technical regulation are put forward for both domestic and foreign manufacturers. The legislation distinguishes a concept of “European harmonized standards”, voluntary compliance with which is a confirmation of compliance of medical devices with technical regulations on medical devices. In this list, approved by the Order of the Ministry of Economic Development and Trade of Ukraine № 663 from 24.06.2015, it is worth to highlight the profile standard for manufacturers of medical devices – DSTU ISO 13485: 2005.

The QMS is mandatory for the following classes of medical devices:

• Medical devices Is (sterile);
• I with measuring functions;
• IIa, IIb, III classes, according to Technical Regulations for medical devices (PKMU №753);
• Reagents, calibrators and controls included in Lists “A” and “B” of the Technical Regulation on in-vitro diagnostic medical devices (PKMU №754), products for self-monitoring;
• All medical devices covered by the Technical Regulation on active implantable medical devices (PKMU №755).

DSTU ISO 13485:2005 standard is developed on the basis of European standard ISO 13485: 2003, but has some inherent minor features. QMS should be developed and implemented in the enterprise, certification of the system is not a mandatory requirement of technical regulations and is performed at the request of the manufacturer.

For domestic producers, who are planning to export their products to EU markets, the presence of the implemented system according to the international standard ISO 13485 is a mandatory requirement.

Often the company already has a quality management system, and it requires analysis and improvement in order to meet the requirements of DSTU ISO 13485: 2005. Conformity assessment bodies “approve” the QMS and “confirm” that it meets the requirements of technical regulations, but it is possible (at the request of manufacturer) to certify the QMS, receiving a certificate of conformity of quality management system along with a certificate of product compliance.

Kratia company offers services:

• Diagnostics and analysis of quality control system operating at the enterprise.
• Development of documentation: quality guidelines, standard operating procedures (SOP), instructions, procedures, policies, procedures, etc.
• Conducting staff training on:
  • Fundamentals of quality management. Standard ISO 13485;
  • Internal audit of the QMS. Standard ISO 19011; Internal Audit of QMS;
  • Directives 93/42/EEC, 98/79/EEC, Technical Regulations of Ukraine;
  • Risk management for medical devices, ISO 14971;
• Implementation of quality management system;
• Pre-certification audit.

Budget for development and implementation of QMS depends on several factors:

1. The number of personnel involved in the production of medical devices.
2. Availability of regulatory documents in the enterprise (SOPs, orders on employment of employees, job descriptions, registries with supplier assessment, work instructions (safety engineering, electrical safety, fire safety), etc.
3. Availability of other QMS at the enterprise (ISO 9001, Good Manufacturing Practice – GMP and others).
4. The list of products, production lines.
5. Types of production operations performed in the production facility.