Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant and comprehensive updates to requirements and methods for demonstrating safety and efficacy.
Fortunately, as the medical device regulatory space grows in complexity, so does the availability of relevant information and expertise. The intent of this white paper is to provide a high-level survey of critical regulatory changes for electronic-based medical devices over the last several years, particularly EN60601-1, ISO 14971 and the fourth edition of EN60601-1-2. This paper also includes pointers to more in-depth information and dedicated resources to help guide device developers through critical aspects of the regulatory process.
As with all medical devices, makers of electronic and electromechanical devices must comply with overall quality systems requirements (e.g. ISO 13485) and country-specific pre-market clearance processes, along with a wide range of more technology, and/or application-specific standards and guidelines. For electrical medical devices, arguably the most significant standard for compliance is EN60601-1: Medical electrical equipment – Part 1- General requirements for basic safety and essential performance. This standard, originally published as an IEC document in 1977, is in many ways at the top of the hierarchy of documents outlining safety and performance requirements for electronic and electromechanical medical devices. While it has evolved significantly over the last 40 years, its intent remains the same: to provide a framework for safety in electrical medical devices.
Third Edition of 601-1
Prior to 2005, the 601-1 standard was limited in scope to safety only, largely specifying construction and testing requirements to ensure the physical safety of patients and operators of a device. Performance of devices, while always considered by manufacturers, was addressed by other standards and guidance documents. However, the 601-1 standard has undergone significant changes within the last ten years, growing in size and complexity. In 2005, the third edition of the 601-1 standard was published, and the scope of the standard increased from “basic safety” alone to “basic safety and essential performance”.
The new standards, adopted nearly worldwide by 2013, require manufacturers to design and test their products to ensure that they deliver performance “necessary to achieve freedom from unacceptable risk”. As implied by this statement, a significant aspect of the 3rd edition is a broad requirement that manufacturers document formal risk analysis cross-referenced to all of the requirements in the standard. A number of good resources are available that provide more detailed information around the third edition standard and the risk assessment-based approach it requires in the context of “essential performance”. Two of these resources are: the Intertek white paper: IEC 60601-1: The New Philosophy of the 3rd Edition, Sept 2010, and miscellaneous information found at 60601-1.com/download.html.
In 2014, an update to the third edition of 601-1 was published and has since been labeled Edition 3.1. In response to industry feedback, Edition 3.1 was an attempt to clarify some of the new risk-based concepts and requirements incorporated in the third edition. Edition 3.1 also added software and usability testing and process requirements, previously included on other related standards, and it incorporated numerous mechanical, electrical, and labeling requirements changes. The 3.1 Edition has an FDA deadline for compliance of August 1, 2016, with a EU transition date of January 1, 2018. A good source for information on 601-1, Edition 3.1 is the UL Whitepaper: The New Paradigm for Medical Device Safety Addressing the Requirements of IEC 60601-1 Edition 3.1, 2015.
Additional Standards and Notable Revisions
Numerous additional standards and guidance documents for medical electrical equipment have been issued, including the collateral and particular standards under the EN 60601 umbrella. Many of these documents have been revised in the past several years, some in concert with the 601-1 revisions, and some with less directly-linked updates. Particularly notable revisions, which apply across all electronic medical devices, have been made to ISO 14971, Application of Risk Management, and EN 60601-1-2, Electromagnetic Compatibility Requirements and Test.
Update to ISO 14971
ISO 14971 was most recently updated in 2012 and includes a significant change to the required approach for assessing risk of medical devices. The prior version of the standard allowed manufacturers to assess, mitigate and reduce risks to a point which was deemed “As Low as Reasonably Practical” (ALARP). The 2012 version of the standard replaced the concept of ALARP with a new risk reduction bar defined as “As Far As Possible” (AFAP). Per the updated standard, manufacturers are required to reduce all risk “as far as possible” to the point where further mitigation does not provide further risk reduction.
The new standard also promotes clinical risk/benefit analysis, with the understanding that the benefit(s) provided by a medical device must be weighed against risk for the ultimate benefit of patients and users. As an aside, it is worth noting also that while ISO 14971 has been a recognized standard by the FDA and most other governing bodies for many years, compliance with ISO 14971 is now specifically required by the current EN60601-1 standard.
Fourth Edition of EN60601-1-2
The electromagnetic compatibility (EMC) standard that applies to medical devices, EN60601-1-2 is another standard that has been recently updated. In large part, this was done to keep pace with technology advancements, particularly in the area of wireless communications. The fourth edition of this standard, published in 2014 with compliance required by the FDA by April of 2017, increases electrostatic discharge performance requirements for most devices, adds labeling and IFU requirements, adds requirements specifically related to proximity of wireless communications devices, and modifies a number of test requirements related to environmental conditions. Like all 601-1 collateral standards, the EMC standard also incorporates the concept of “essential performance” into test and verification requirements.
While it is difficult to provide a comprehensive list of new and updated standards beyond those listed above, clearly the medical device industry has been impacted by many such documents within the last 5 years. For developers of software and electronic-based devices, among these noteworthy new or updated standards are the following:
- IEC 62304 – Medical Device Software Development
- EN 60601-1-6 and IEC 62366 - Usability and Human Factors
- EN60601-1-8 – Alarms
- EN60601-1-11 – Home Healthcare Devices
- IEC 82304 – Health Software (draft) for stand-alone software
In addition, the following FDA Guidance documents are important for their impact on new technology and devices:
- Applying HF and Usability
- RF Wireless Technology in Medical Devices
- Infusion Pumps Total Product Lifecycle
- Management of Cybersecurity in Medical Devices
- Content of Premarket Submissions for Software
FDA guidance documents can be found on the FDA website at: http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/
Developing medical devices has always been, and will always be, a challenging and rewarding endeavor. Designing and testing for compliance to regulatory standards is a key piece of successful product introduction. As device technology continues to evolve at a quickening pace, regulatory requirements and required knowledge associated with designing, testing and documenting compliance also grow in depth and breadth. Fortunately, there are many resources available for developers, including on-line information from regulatory bodies and testing agencies as well as expertise from development and manufacturing partners and regulatory and compliance specialists. Successful medical device professionals, particularly those dealing with complex electronic, software and electromechanical products, are those who understand the ongoing evolution of the regulatory environment, expect and stay abreast of ongoing changes and revisions, and establish a strong network of regulatory, compliance, and testing resources.