What is EN 46001 Standard?
Companies producing medical devices need to establish an effective quality system in their enterprises in order to provide customer satisfaction, to fulfill the requirements of the legal regulations in force, to reduce the costs and increase the efficiency of the company and to create a legal guarantee against possible conflicts.
In order to meet these expectations, the first standard prepared for the medical devices manufacturing sector is EN 1997 and EN 46001 standards developed in 46002 in European countries. These standards ensure that medical product suppliers comply with European norms. Fulfillment of the requirements of these standards in accordance with the directives of the European Union is a prerequisite for its products in the medical sector. These standards describe specific requirements beyond the requirements that suppliers must meet by the ISO 9001 Quality Management System standard. The certification of a quality management system that complies with ISO 9001 and EN 46001 standards, especially for medical devices, provides numerous advantages for medical companies exporting their products to global markets.
The standards of medical devices published in 1997 are:
- EN 46001 Specification for the application of EN ISO 9001 to the manufacture of medical devices
- EN 46002 Specification for the application of EN ISO 9002 to the manufacture of medical devices
These standards were published in our country under the following headings in the same years, but were later abolished:
- TS EN 46001 Quality systems - Medical devices - Specific requirements for the implementation of the EN 29001 standard
- TS EN 46002 Quality systems - Medical devices - Specific requirements for the implementation of the EN 29002 standard
ISO 13485. Medical Devices Quality Management System What is the Standard?
The International Standards Organization (ISO) Technical Committee published the ISO 2003 Medical Devices Quality Management System standard in 9001, based on both the standards described above and the ISO 13485 Quality Management System standard. This standard specifies the minimum requirements for companies producing medical devices. Although the ISO 13485 standard is based on the ISO 9001 standard, it also contains additional requirements specifically designed for medical devices.
The companies that established ISO 13485 Medical Devices Quality Management System in their enterprises provide free circulation of the produced medical devices in European Union countries and other foreign countries. In this respect, all enterprises producing medical devices are required to establish and implement ISO 13485 Medical Devices Quality Management System. Although this standard was born in the European Union countries, it is now accepted by all countries. Not only by the manufacturing companies, but also all the companies that make installation and installation of medical devices and provide technical support services after the installation, ISO 13485 Medical Devices Quality Management System certificate is required.
The main objective of the ISO 13485 standard is to ensure global compliance of the quality requirements of medical devices. Briefly, it is a standard that defines the conditions that quality systems must meet for all businesses operating in the fields of manufacturing, trading and distributing medical devices.
ISO 13485. Medical Devices Quality Management System What Does Business Gain?
In principle, the ISO 13485 standard, just like the ISO 9001 standard, shifts from a classical quality control approach to a process-based approach and envisages a direct relationship between the business objectives and productivity. In this respect, the gains of the medical device manufacturers that apply the ISO 13485 standard in their enterprises can be listed as follows:
- Businesses demonstrate that they operate in accordance with the requirements of the legal regulations in force
- Enterprises producing medical devices must apply this system to put CE marking on their products
- The company proves to its customers that it operates in compliance with an internationally recognized standard.
- In this respect, businesses develop their customer portfolios faster and gain advantages over their competitors.
- Reduces customer complaints and increases customer satisfaction
- Improper production decreases significantly and costs of the enterprise decrease
- This naturally increases the profitability and reputation of the enterprise.
- There is an increase in foreign sales of the enterprise
- Thanks to the system, the activities of the company are monitored more systematically by the senior management.
- Failures of the system are detected and corrected by faster, easier and more convenient methods
- Efficiency and continuity in business activities are achieved
What are the regulations issued by the Ministry of Health?
In order for medical devices manufactured in our country to be accepted in European Union countries, these products must be produced in accordance with the European Union directives. On the other hand, efforts are underway to bring our existing legal arrangements in line with the European Union directives within the scope of the transition process to the European Union. Within this framework, the following regulations were issued by the Ministry of Health:
- Medical Device Regulation (in 2007)
- Regulation on In Vitro (Used Outside Body) Medical Diagnostic Devices (in 2007)
- Regulation on implantable active medical devices (in 2011)
The Medical Device Directive sets out the basic requirements for medical devices and equipment, and sets out guidelines for the design, production, placing on the market and supervision of these devices and their equipment to ensure that they are protected against hazards that may arise in terms of health and safety during use.
The In Vitro Medical Diagnostic Devices Directive sets out the basic requirements for in vitro medical diagnostic devices and equipment, and sets out guidelines for design, production, placing on the market, and monitoring so as not to jeopardize the health and safety of people during the use of these devices and their equipment. .
The Pluggable Active Medical Devices Directive specifies the basic requirements for implantable active medical devices and regulates the principles for design, manufacturing, placing on the market and supervising the safety and health of people during the use of these devices.
All medical device manufacturers who want to control production and service processes and open to foreign markets must obtain ISO 13485 Medical Devices Quality Management System certificate.
