To ensure the quality and safety of medical electronic devices on its market, the European Union requires both its domestic manufacturers and those wishing to export their products to the EU to possess a CE marking, which is given to the products that acquire a Certificate of Conformity. A product can only receive such a mark if it meets the requirements for electronics manufacturing in the EU. While ISO standards are not mandatory, complying with them helps to successfully obtain the CE marking. Here is more information on the main ISO standards for medical device manufacturing.
The EU market regulations
The most current regulations for medical device manufacturing in Europe are contained in the Medical Device Directive (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). The MDR focuses on regulating medical devices designed for external use, while the IVDR concerns medical electronic devices used in internal procedures.
Although all new devices placed on the market in the EU must comply with these directives, it is still legal to market electronic equipment which obtained the conformity certificates due to compliance with the previous directives: 93/42/EWG (MDD) and 90/385/EWG (AAIMDD). This permission is valid until May 27, 2024.
ISO certifications help original equipment manufacturers (OEMs) comply with the above regulations. In addition, all electronics manufacturing service providers (EMS) involved in medical device manufacturing must comply with the same regulations. Only those OEMs who can demonstrate that each company contributing to the production of their devices meets with the EU market requirements can legally launch their products.
The scope of the regulations
Due to the complexity of medical electronic devices and their potential impact on the health of their users, EU directives aim to ensure the absolute safety of such devices. Yet, neither these directives nor the ISO standards impose any particular technology for manufacturing devices used for specific purposes. In this sense, the regulations allow complete freedom in researching medical devices, improving them, and inventing new ones. Nevertheless, the guidelines are strict about the health effects of such devices.
To make it possible for these two approaches to coexist, the regulations focus on different components of production and its management. For example, electronics manufacturers are required to develop effective quality and risk management systems and to maintain comprehensive technical documentation. Manufacturers are also expected to ensure the traceability of their devices during and after production and to mark them with unique identification codes (UDI). In addition, these guidelines require manufacturers to conduct a clinical evaluation of their devices and to monitor the equipment that is already on the market.
Basic standards in the medical electronic device industry
Although manufacturers can arrange their work to meet market requirements without obtaining ISO certificates, this approach can unnecessarily complicate and prolong the process of launching a new product. Obtaining four key ISO standards can greatly simplify the process of bringing a medical device to market in the EU.
These standards include the generally applicable ISO 9001 for quality management systems and more specific standards such as ISO 13485 for medical device quality management systems, ISO 14001 for environmental management systems, and ISO 22301 for continuity management systems. Poland-based EMS provider Assel holds all of these certifications.
Co-operation with a certified EMS provider
Since appropriate ISO certification is the best proof of compliance with the EU market regulations, an EMS provider that has obtained such certificates will ensure manufacturing of your devices is in line with the UE directives. To learn more about the certified contract manufacturer Assel, go to https://asselems.com/en/medical-electronics-manufacturing1
