Medical devices range from simple heating blankets, electrical hospital beds, or electronic fever thermometers, to complex programmable electronic equipment such as Magnetic Resonance Imaging (MRI), medical lasers, incubators, cardiac monitors, and other life-support devices.
All of them need to meet a rather complicated set of safety requirements. Compliance regulations heavily affect their design and manufacture, including mechanical, electrical, and software matters.
Standards, regulations, and verification are closely linked. Standardized technologies that are tested and certified for safety, quality, and performance contribute to overall risk management. They also help improve processes and the understanding of device interactions.
Broader access to affordable quality healthcare:
- Trade in medical electrical equipment is global. This lends emphasis and importance to an international approach in standardization but also to greater regulatory convergence.
- The use of harmonized, globally agreed technical rules - generally IEC International Standards - with few or no national/regional variations helps increase the availability of safe, affordable, quality medical devices. At the global level, this results in broader access to better healthcare.
- Clear, harmonized regulatory guidelines also help encourage investment in R&D and future innovations.
Who is involved ?
Many different stakeholders including manufacturers, healthcare providers, clinicians, or regulators contribute to the development of international medical standards. When appropriate and to ensure that international healthcare standards fit seamlessly together, IEC technical committees cooperate with other committees of the IEC, ISO, WHO, and other organizations, based on the expertise each organization embodies.
International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMDRF) is an organization of national regulatory authorities dedicated to promoting international convergence of regulatory requirements and practices. In particular, the IMDRF aims to promote harmonized regulation of the safety, performance, effectiveness, and quality of medical devices and to serve as an information exchange through which countries with medical device regulatory systems under development can beneﬁt from the experience of countries with established systems.
The IMDRF was founded in 2011 as the successor to the Global Harmonization Task Force (GHTF), which was a voluntary group of medical device regulators from Europe, the U.S.A., Canada, Japan and Australia, and their industry partners.
National health authorities
The majority of regulation of medical devices still takes place at the national level. In every country one or more governmental bodies have the authority to oversee and regulate aspects of the national health care system. This includes generally the development, manufacture and distribution of medical devices, approval prior to commercial distribution, and post-market surveillance of their safety and performance.
Many national regulatory authorities actively participate in the development of IEC and ISO International Standards by contributing experts appointed through their national member body. These experts directly represent the viewpoints of national or regional regulatory authorities and ensure that standards will meet the needs of countries across diverse geographies, cultures and economies.
World Health Organization
The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. WHO is charged with providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends. WHO experts actively participates in the work of IEC and ISO TCs as a Category A liaison.
IEC and ISO committees
Many IEC and ISO committees develop international standards that play an important role in the regulation of medical devices. These include:
Electrical equipment in medical practice
Safety of measuring, control and laboratory equipment
Optical radiation safety and laser equipment
Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
Anaesthetic and respiratory equipment
Implants for surgery
Prosthetics and orthotics
Microscopes and endoscopes
Ophthalmic optics and instruments
Biological evaluation of medical devices
Sterilization of health care products
Quality management and corresponding general aspects for medical devices
Clinical laboratory testing and in vitro diagnostic test systems
Many of these standards are used by the IEC System for Conformity Assessment, IECEE-CB Scheme to issue international IECEE-CB Test Certificates which are used for:
- direct product acceptance, in some countries
- acceptance of tests and assessments performed in one country by other countries who participate in this scheme
How is regulatory cooperation in this ﬁeld achieved?
In line with the World Trade Organization's Technical Barriers to Trade Agreement, some national and regional medical device regulators have adopted systems that utilize standards to support their regulation. Standards are usually not mandatory but provide a presumption of conformance with specific regulatory requirements. A key to the success of this approach is the close cooperation between IEC, ISO and other bodies, and the participation of regulators alongside medical device manufacturers and users in the development of international standards .
Several IEC Standards are now globally recognized by medical device regulators:
- IEC 60601 series is widely recognized as the basic safety and essential performance standard for medical electrical equipment
- IEC 62366 has established a broadly recognized process model for achieving and validating optimal usability of devices
- ISO 14971, which was jointly produced by IEC SC 62A and ISO TC 210, has become the benchmark for the medical device risk management process.
Navigation and communications
Rapidly evolving and highly regulated
Measuring energy performance
Dependent on electric and electronic components
Cutting across many different industry sectors
Protection from interference
Electrical equipment and systems for railways
Safety, security and the environment
Power consumption tests