This blog shares how to identify which medical device standards apply to the device you’re bringing to market and provides an overview of major standards at various regulatory levels for novices.
The world is a global village and that often leads to questions of medical device compatibility, safety and standards. Conformance with standards can help provide reasonable assurance of safety and/or effectiveness for many aspects of medical devices. They can also facilitate the manufacture and trade of medical devices at the international level.
How to determine which standards apply to your medical device?
Determining which standards apply to a particular medical device can be tedious as there is no “one-stop shop” to search.
The horizontal standards are a good place to start as they are broadly applicable to most medical devices. These include, but are not limited to ISO 14971: Application of risk management to medical devices, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices, and ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes (although this standard is not recognized by all Regulatory Authorities, including the FDA, and is written into regulation by others, such as Health Canada).
The semi-horizontal standards or group safety standards can be considered next. For instance, if a medical device has software, then IEC 62304: Medical device software – Software life cycle processes is applicable. Electronic medical devices are applicable to IEC 60601-1: Medical electrical equipment – General requirements for basic safety and essential performance.
IEC 60601 is actually a series of standards for the safety and essential performance of medical electrical equipment and is a widely accepted benchmark for electronic medical devices. IEC 60601-1 is the general safety standard and there are multiple collateral and particular standards. The collateral standards (denoted 60601-1-X) define the requirements for certain aspects of performance and safety (e.g. IEC 60601-1-2 for Electromagnetic disturbances – Requirements and tests, IEC 60601-1-11 for Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). Particular standards (denoted 60601-2-X) define the requirements for specific products or measurements built into products (e.g. 60601-2-4 for cardiac defibrillators, 60601-2-18 for endoscopic equipment). One should browse the titles and scope to determine which standards in the series may apply to a particular device.
ISO 10993 (Biological evaluation of medical devices) is another semi-horizontal series of standards applicable to medical devices that come into direct or indirect contact with the human body. ISO 10993-1 guides you on how to conduct a risk-based biocompatibility assessment of the device based on the material components, the manufacturing processes, and the clinical use of the device (intended anatomical location and the frequency and duration of exposure). The remaining standards cover chemical and biological testing including, but not limited to, tests for identifying and quantifying degradation products, irritation and skin sensitization, cytotoxicity, interactions with blood, local effects after implantation, and systemic toxicity. An interesting example of partial recognition by a Regulatory Authority is the acceptance of the ISO 10993 series of standards by the FDA. The FDA has published its own guidance document on the use of ISO 10993-1 with modifications to support premarket submissions. The ISO 10993 series often includes general methods with multiple options, and sometimes does not include acceptance criteria or address assessment of results. Therefore, the FDA recommends that if a declaration of conformity is submitted for an FDA–recognized standard in the series, then supplemental information is also submitted to support the declaration (e.g. study test reports).
Finally, any applicable vertical (or product-specific) standards should be determined. An approach here is to begin by searching databases of recognized standards maintained by Regulatory Authorities or webstores of standards organizations for the device type (e.g. the FDA Recognized Consensus Standards Database). FDA also links recognized consensus standards to device types through its Product Code Classification Database. This database is searchable by device type or by product code (if known). Alternatively, if a predicate device has been identified, the FDA’s 510(k) Premarket Notification Database can be searched to determine the relevant product code and recognized consensus standards.
If a medical device represents a new type of device and/or emerging technology, standards may not yet exist or be in a draft form. If a standard is in draft form, it may be worth communicating with the relevant Regulatory Authority to determine the approach to conforming with the standard as it will not yet be known whether the Regulatory Authority will recognize the standard. It is also worthy to note that if a medical device is classified as an accessory (intended to support, supplement and/or augment the performance of another device), the accessory and parent device may need to be tested together to validate that, when used together, the system functions as intended.
The keys to success
It is imperative to determine the following as early as possible in device development as they will all have an impact on which standards apply:
- The intended use
- The intended user population
- The environment where the device will be used
- The target countries for market entry
Once you determine which standards apply to your medical device, it is important to check which versions of standards are recognized by each target country, whether they recognize an international standard in full or have their own national version, and whether the standard is considered voluntary or mandatory.
Overview of standards and why are they important
The International Organization for Standardization (ISO) describes a standard as “a document, established by a consensus of subject matter experts and approved by a recognized body that provides guidance on the design, use or performance of materials, products, processes, services, systems or persons”. Standards contain technical specifications or other precise criteria to ensure that materials, products, processes, services, systems or persons are fit for their intended purpose. They help to ensure consistency of essential features of goods and services like quality, effectiveness, safety, reliability, and compatibility.
Standards are typically referenced in three parts: the issuing organization, the number of the standard, followed by the year of issue. For example, ISO 14971:2019 is a standard issued by ISO in 2019. The title is “Medical devices — Application of risk management to medical devices”.
How are standards developed and what types exist?
Standards are issued at different levels:
- National (e.g. American National Standards Institute or ANSI in the US)
- Regional (e.g. European Committee for Standardization or CEN)
- International (e.g. ISO and the International Electrotechnical Commission or IEC)
National standards bodies (NSBs) publish their own national standards and represent their country during the development of regional and international standards. NSBs may accept international standards, but then add their own country-specific requirements based on their concerns, laws, and regulations.
There are three main types of standards:
- Horizontal (or basic safety standards): Describe fundamental concepts, principles and requirements for the general safety of all or a wide range of products/processes (e.g. risk management, usability engineering principles, and quality management)
- Semi-horizontal (or group safety standards): Applicable to a group of similar products/processes (e.g. sterility, electrically-powered devices)
- Vertical (or product safety standards): Define product-specific safety requirements (e.g. infusion pumps, ventilators)
Most standards are developed in response to a need in the market. They are developed by a panel of experts in the field (Technical Committees) represented by industry, consumer associations, academia, non-governmental organizations and government. The standards are periodically reviewed and updated to reflect the latest technological developments.
How does conformance with standards support a regulatory pre-market submission?
Standards are a valuable resource for both industry and Regulatory Authorities. While regulations generally address the safety and performance principles for medical devices, they cannot address detailed specifications pertaining to specific products or processes due to the vast diversity of medical devices. Also, it is easier to update a standard than to change a regulation. Conformance with standards can provide reasonable assurance of safety and/or effectiveness for many aspects of medical devices. For these reasons, Regulatory Authorities support the development of and rely on the use of standards as tools to facilitate market entry.
Other benefits to industry and Regulatory Authorities include:
- Streamlining premarket submission review by reducing the amount of documentation provided and Regulatory Authority review time
- Providing clearer regulatory expectations and increasing predictability
- Promoting international harmonization of regulatory processes
The use of standards to meet requirements of premarket submissions is voluntary, unless a particular standard has been written into a regulation and is therefore mandatory. Regulatory Authorities will recognize a particular standard either in full or in part. The recognized version may not always be the most current. Many regulatory bodies maintain searchable databases of recognized standards. Conformance with recognized standards alone, however, may not be sufficient to address all safety and efficacy concerns for a particular device or premarket submission type.
When using conformance with a standard to support safety or effectiveness, the manufacturer should retain documentation to demonstrate that the device complies with the standard (e.g. the standard itself, how it was applied, test results and/or other outputs, deviations, etc.). If a standard is not applied in full, information must be provided to justify why those clauses were deemed not pertinent to the particular medical device. When a recognized standard is applied in full, a “declaration of conformity” may be submitted with the premarket application in lieu of the technical documentation.
The benefits of standardization are important internationally for manufacturing and trade of medical devices. Standards represent the current state of the art in a technological field and are building blocks for harmonized regulatory processes to assure the safety, quality and performance of medical devices worldwide. Knowing which medical device standards apply to your device is an essential part of successfully bringing a medical device to market.
Tara Lysechko is a senior QA/RA specialist at StarFish Medical. Tara has 11 years of natural health product industry experience in Regulatory Affairs, including seven years consulting to start-up companies. At StarFish Medical, Tara provides quality assurance and regulatory support for the design, development and manufacture of innovative medical devices. She holds a Ph.D. in Immunology from the University of Alberta.