Navigating the regulatory maze: A short guide to medical device standards and certifications

Medical device standards and certifications are crucial for ensuring thousands of medical devices’ safety, efficacy, and quality. These standards, often set by international bodies like the International Organization for Standardization (ISO), provide a framework for manufacturers to design, produce, and distribute medical devices that meet rigorous regulatory requirements.

Certifications, such as CE marking in the European Union, are needed for market access. While there is no formal certification for individual medical devices, manufacturers must certify their quality management systems to comply with regulations like the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These certifications ensure that devices meet safety and efficacy standards, enhancing customer trust and facilitating global market access.

Which are the standards that medical devices must comply with before going on the market?

ISO 13485 is the primary of the medical device standards, that outlines the requirements for a Quality Management System (QMS) specifically designed for the medical device industry. Being compliant with the ISO 13485 standard means that the medical devices are safe and effective for their intended use, and the entire lifecycle from design and development to production, installation, and servicing is covered. This standard helps manufacturers and suppliers to meet rigorous regulatory requirements, manage risks, and demonstrate a commitment to safety and quality.

IEC 62304 is the standard that shapes the life cycle requirements for the development of medical device software. This standard provides a framework for guaranteeing the safety and effectiveness of software used in medical devices, covering processes from initial planning through deployment and maintenance. IEC 62304 focuses on risk management, requiring manufacturers to identify, assess, and mitigate risks associated with software failures that could impact patient safety or device performance.

ISO 14971 is a medical device standard that helps manufacturers to manage risks associated with medical devices throughout their lifecycle. It is a process consisting in identifying hazards, assessing risks, implementing controls, and monitoring their effectiveness. This standard ensures safety and effectiveness of the medical devices, including software as a medical device and in vitro diagnostic medical devices.

Other industry standards are ISO 17025 which refers to the general requirements for the competence of testing and calibration laboratories, ensuring that laboratories can produce accurate and reliable results; and ISO 11135 responsible for the validation of sterilization processes for medical devices.

What about Certifications?

Here are some key aspects of certifications and regulatory compliance medical devices must comply to meet rigorous safety and quality standards.

CE marking for medical devices is a mandatory conformity required for devices intended for medical use, signifying that a product meets the safety, health, and environmental protection standards set by EU regulations, such as the Medical Device Regulation and In Vitro Diagnostic Regulation. Having this certification enables the medical devices manufacturer to sale across the EU and other regions that recognize the CE mark.

Speaking of MDV and IVDR, these regulations are significant updates to the European Union’s regulatory framework for medical devices. They do not only make the devices more performant but also enhance patient safety and improve transparency.

In the USA you need to be FDA compliant and have 510(k) Clearance to be able to market and use different medical devices. So, if your product is designed for the US market, meeting the FDA standard means that you must cover certain aspects such as design, production, testing and post-market surveillance. 510(k) clearance addresses moderate-risk devices, which are classified as Class II. It facilitates innovation by enabling the introduction of new technologies that build upon existing ones. What does this mean? It means that a predicate device must already be on the market and the new device must have the same intended use and technological characteristics as the predicate, so that it does not raise new safety or effectiveness concerns.

Which are the benefits of certification?

Market access gain – certification opens up markets globally, especially in regions where specific standards are recognized.

Quality Assurance – ensures that products meet rigorous safety and efficacy standards.

Customer Trust – enhances credibility with healthcare professionals and patients.

Medical device standards and certifications are necessary for ensuring safety, quality, and regulatory compliance. By understanding these frameworks, manufacturers can effectively navigate global markets while maintaining high standards of product quality and safety.

AROBS Engineering supports its partners through every stage of software development from requirement analysis and design to development, validation, testing, quality assurance, ensuring that medical device standards and certifications requirements are met. Harness our embedded software expertise to enhance the brilliance, performance, and connectivity of your cutting-edge medical devices.

Read more about our medical software expertise – https://arobs.com/medical-devices/.