Beyond IEC 60601: Standards and Medical Device Safety by Design

1. Strict Safety Standards: Medical diagnostic and surgical systems must adhere to stringent safety standards, with IEC 60601 being the most well-known. Understanding these standards and the influence of regulatory bodies like the FDA and EU is crucial for global compliance.
2. Market Growth: The global medical device market is rapidly expanding, projected to grow from $471 billion in 2020 to $623 billion by 2026. This growth necessitates evolving safety standards to balance technological advancement with safety.
3. Historical Context: Safety standards like IEC 60601 have evolved from earlier regulations, reflecting the medical industry’s proactive approach to safety and adaptation to modern device functionalities.
4. IEC 60601 Framework: This series of standards focuses on mitigating risks such as electric shock, mechanical hazards, and radiation. It also addresses labeling, documentation, and software aspects of medical devices.
5. Complementary Standards: Other standards, such as ANSI/AAMI and ISO 14971, complement IEC 60601 by providing additional safety perspectives and risk management processes.
6. Regulatory Oversight: The FDA and EU play key roles in ensuring medical device safety through rigorous testing and compliance processes. Despite differences, global harmonization efforts aim to streamline compliance.
7. Supplier Support: Manufacturers rely on suppliers for products that simplify compliance. Advanced Energy, for example, offers power solutions that meet IEC 60601-1 standards and operates Customer Experience Centers to support equipment designers.
8. These points highlight the importance of safety standards in the medical device industry and the ongoing efforts to ensure compliance and safety in a rapidly growing market

	FDA	CE Marketing
Approval Process	Requires a more rigorous pre-market approval process for certain classes of devices, which often includes detailed clinical trial data.	Generally, focuses on  demonstrating compliance with the relevant European directive or regulation, which can be a less stringent process compared to the FDA's pre-market approval, especially for lower risk devices.
Clinical Data Requirements	Typically demands extensive clinical data for higher-risk devices, and this data must often be derived from clinical trials conducted in the U.S.	The requirement for clinical data is less stringent, and there is greater flexibility in the types of clinical evidence that can be used to support device safety and efficacy.
Quality System Regulation	Enforces Quality System Regulation (QSR), which requires manufacturers to follow specific procedures and documentation for design, manufacturing, and quality assurance.	Requires compliance with ISO 13485 standards for medical devices, which have a similar focus but differ in terms of specific procedures and documentation.
Post-Market Surveillance	Has a robust post-market surveillance system, including mandatory reporting of adverse events and periodic inspections.	Also requires post-market surveillance, but the mechanisms and frequency of reporting can differ, with a recent emphasis on more rigorous surveillance under the new MDR.
Scope and Enforcement	Its regulations are legally binding in the United States, and the FDA has enforcement authority including the ability to recall non-compliant products.	The CE mark indicates conformity with EU standards, which are enforced by individual member states and require manufacturers to self-declare their compliance with these standards.
Classification System	Uses a classification system based on the risk associated with the device (Class I, II, and III).	Also classifies devices based on risk, but the criteria and categories can differ from those used by the FDA.
Documentation and Registration	Requires a formal submission process for most devices, which can include a Pre-market Approval (PMA) or 510(k) submission.	Manufacturers must compile a technical file or design dossier demonstrating compliance with the applicable directive. This documentation is usually reviewed by a notified body, except for lower risk devices, which may only require self-certification.

Distinctions between medical device safety standards in the U.S. and Europe illustrate a varied regulatory landscape. While the core objective to safeguard public health is universal, each region has its own idea of how to reach this goal.

Regulatory harmonization and global compliance are achieved through several key strategies such as international standard development, collaborative regulatory forums, mutual recognition agreements, continuous monitoring and updates, guidance documents and other collaborative efforts. However, challenges remain due to differences in national healthcare systems, regulatory philosophies and legal frameworks. 

How Suppliers Can Help

The complexities of addressing the various certification requirements for globally deployed medical equipment means that manufacturers increasingly expect their suppliers to provide products that simplify compliance and offer guidance, technical support and even pre-certification testing.

In addition, Advanced Energy operates Customer Experience Centers (CECs) in strategic locations worldwide that are staffed by engineers who work with customers at the system level. These centers help to guide equipment designers through the development journey to minimize risk and ensure that all performance, safety and regulatory targets are met in designs that are cost-optimized for target applications. Click here for more information on Advanced Energy’s CECs.