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Production Standards in the Medical Industry

Production for the medical industry must comply with strict standards to ensure that equipment placed on the European Union market meets the legal requirements. These standards ensure safe and effective products that medical personnel can use to treat and save patients' lives. These standards are developed after global consultation with several qualified organizations. Therefore, manufacturers of medical devices are obliged to comply with them, whether they are responsible for all or part of the production. Let's take a look at what these standards are.

Placing a product on the market is "the first time a product is made available on the Union market." Product is placed on the market when it is transferred towards the end of the production phase (a product manufactured in the European Union) or imported into the Union's territory. Placing on the market refers to each product and not the product or model reference number, whether produced singly or in series. Depending on the given product's nature and technical characteristics, there may be other regulations and standards required for the production of the product to be placed on the market. Particularly stringent standards apply to products for the medical industry.

Here you can find more information about Medical Electronics Manufacturing: https://asselems.com/en/medical-electronics-manufacturing


Legal regulations

The most critical challenges that medical device manufacturers may face to comply with EU regulations are contained in two rules:

  • on medical devices (Medical Devices Regulation - MDR)

  • on medical devices for in vitro diagnostics (In-vitro Diagnostic Medical Devices Regulation - IVDR)

The European Union regulations on medical devices were published in May 2017 and repealed the existing directives 93/42 / EEC (MDD) and 90/385 / EEC (AAIMDD). Until May 26, 2020, producers had the opportunity to adapt to their regulations. For three years, transitional provisions were in force. Today, however, there can be no question of any deviations from the standards contained in the MDR and IVDR regulations. Manufacturers have a responsibility to comply with them to ensure that equipment that leaves their factory can treat patients. However, it is worth noting that following legal regulations, devices with certificates of conformity issued based on the MDD / AAIMDD directives may be placed on the market until May 27, 2024.

What's in the new rules?

Under regulations contained in the new rules, manufacturers of medical devices are mandated to ensure:

  • Functioning of quality management systems and risk management systems

  • Application of systems enabling the marking of devices with unique identification codes

  • Preparation of technical documentation for manufactured products

  • Involvement of conformity assessment methods

  • Conduct clinical product evaluations

  • Having a post-market surveillance system in place

Manufacturers who use the services of an EMS provider should therefore verify that the contractor with whom they have established cooperation is adequately prepared and will meet the requirements resulting from the regulations adopted in the European Union.

Four essential production standards in the medical industry

Today, the medical industry must meet the need to accelerate the production process and the demands of global competition. At the same time, production for this industry must meet high standards. The established standards are to provide patients with safe and effective products that they can trust in the hands of experienced doctors. We distinguish four essential ISO standards that enable us to meet the requirements of the EU MDR and IVDR regulations:

  • ISO 13485- quality management system for medical devices

  • ISO 9001 - quality management system

  • ISO 14001 - environmental management system

  • ISO 22301 - continuity management system

Each of the applicable standards is briefly characterized below.

1. ISO 13485 – quality management system for medical devices

ISO 13485 provides a practical foundation for manufacturers to meet regulations and responsibilities and demonstrate a commitment to safety and quality. As a quality management system standard, it does not apply to a specific product but to processes essential for producing medical devices and related services. It includes maintaining general quality control, traceability and validation procedures, and risk management procedures. These quality management standards are prepared following the requirements of the ISO 9001 system, but in a way that extends and specifies these requirements for medical devices.

2. ISO 14001 – quality management system

ISO 14001 is a leading standard for environmental management systems developed with manufacturers striving to operate according to the Lean methodology. ISO 14001 runs based on international standards and confirms the consistent implementation of all elements aimed at the maximum reduction of the negative impact of the organization on the environment. The purpose of implementing the environmental system based on the ISO 14001 standard is the continuous improvement of the effects of ecological activities and preparation for reacting in the event of an environmental threat. This certificate proves that the manufacturer or supplier of contract manufacturing has implemented and maintains procedures for minimizing the amount of waste and resources used.

3. ISO 22301 – continuity management system

The ISO 22301 standard specifies the requirements for a business continuity management system and helps understand the organization better and implement a business continuity strategy. A business continuity management system compliant with ISO 22301 generally provides a clear and detailed view of how an organization operates. It offers valuable insights useful in strategic planning, risk management, supply chain management, business transformation, and resource management. In other words, having this certificate proves that the organization has implemented and maintains risk and risk identification procedures and appropriate security measures. ISO 22301 also confirms that the manufacturer can respond effectively in an emergency.

Why is it important?

Electronic devices for the medical industry must be characterized by high technical advancement and high efficiency, both in their power and speed. They must also guarantee the highest level of safety for patients. Moreover, medical devices must be designed and manufactured to cope with the conditions they may encounter in a complicated medical environment, such as shocks during rapid shipment. There are no compromises in human life and health; therefore, all electronics manufacturers for the medical industry must meet the requirements set out in the European Union regulations. An electronics manufacturing services provider with the above certifications can guarantee quality and production support for the medical industry.


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