The medical devices industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes and needles, is both rapidly evolving and highly regulated.
Standards play an important role in allowing the rapid introduction of new medical device technology while meeting the expectations of the public and regulators that medical devices are safe to use, perform as intended and offer benefits to patients that outweigh the risks.
Key features are:
- Acceptance of standards as a key element in the regulatory framework for medical devices: while not mandatory, standards provide manufacturers with a presumption of conformance to specific regulatory requirements
- Participation of regulators alongside medical device manufacturers and professional users in the development of International Standards
- Close cooperation between IEC, ISO, CEN, CENELEC, WHO and international regulatory harmonization initiatives to develop practical, effective and compliant medical device standards
Who is involved?
There are many stakeholders involved in the medical devices sector, including manufacturers, regulators, healthcare providers, clinicians and patients. Involving representatives from all stakeholder groups is essential to produce standards that promote safety and result in enhanced patient outcomes. ISO and IEC, along with other standards developers, provide a forum where the stakeholders can collaborate to develop standards that achieve these goals while supporting compliance with the various regulatory frameworks in place around the world.
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 USA, Canada, Japan and Australia and their industry partners. The GHTF was instrumental in developing guidance documents and recommended procedures that helped to promote convergence of the medical device regulatory systems of its members.
National Health Authorities
Despite the initiatives of IMDRF to harmonize medical device regulations and converge on a common regulatory system, regulation of medical devices still takes place at the national level. Every country has designated one or more governmental bodies with the authority to oversee and regulate aspects of its healthcare system. Their regulatory activities related to medical devices may include regulation of the development, manufacture and distribution of the medical devices, approval prior to commercial distribution, and post-market surveillance of the safety and performance of the medical devices.
Many national regulatory authorities actively participate in the development of ISO and IEC standards by contributing experts appointed through their national member body. These experts directly represent the viewpoints of their national or regional regulatory authorities and ensure the standards will meet the needs of countries across diverse geographies, cultures and economies.
European Committee for Standardization & European Committee for Electrotechnical Standardization
The European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC) are the organizations charged with developing EN standards. EN standards can give presumption of conformance to directives and regulations of the European Union, including those governing the requirements for medical devices. CEN and CENELEC formally cooperate with ISO and IEC under the Dresden and Vienna Agreement to develop standards that can be applied throughout the whole world, thereby facilitating international trade.
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 participate in the work of 45 ISO technical committees as a Category A liaison, including the committees listed below.
ISO and IEC Committees
Many ISO and IEC technical committees and subcommittees develop standards that play an important role in the regulation of medical devices. These include:
- IEC/TC 62, Electrical equipment in medical practice
- IEC/TC 66, Safety of measuring, control and laboratory equipment
- IEC/TC 87, Ultrasonics
- ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- ISO/TC 121, Anaesthetic and respiratory equipment
- ISO/TC 150, Implants for surgery
- ISO/TC 168, Prosthetics and orthotics
- ISO/TC 170, Surgical instruments
- ISO/TC 172/SC 5, Microscopes and endoscopes
- ISO/TC 172/SC 7, Ophthalmic optics and instruments
- ISO/TC 194, Biological evaluation of medical devices
- ISO/TC 198, Sterilization of health care products
- ISO/TC 210, Quality management and corresponding general aspects for medical devices
- ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems
Many of these standards are used within the IEC’s System for Conformity Assessment, IECEE – CB Scheme for the issuing of International IECEE-CB Test Certificates which are used in both occasions:
- For direct acceptance, in some countries
- For the acceptance of tests and assessments performed in one country being accepted by the authorities of another
In both cases, they provide the regulator and manufacturer with the very benefits of using both International Standards and an International Conformity Assessment System.
- IEC/TC 62
Electrical equipment in medical practice
- IEC/TC 66
Safety of measuring, control and laboratory equipment
- IEC/TC 87
- ISO/TC 76
Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- ISO/TC 121
Anaesthetic and respiratory equipment
- ISO/TC 150
Implants for surgery
- ISO/TC 168
Prosthetics and orthotics
- ISO/TC 170
- ISO/TC 172/SC 5
Microscopes and endoscopes
- ISO/TC 172/SC 7
Ophthalmic optics and instruments
- ISO/TC 194
Biological evaluation of medical devices
- ISO/TC 198
Sterilization of health care products
- ISO/TC 210
Quality management and corresponding general aspects for medical devices
- ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems
- IEC/TC 62
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. In these systems, 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 participation of regulators alongside medical device manufacturers and users in the development of International Standards and close cooperation between ISO/IEC and other bodies in the development of medical device standards.
As a result, many ISO and IEC standards are now globally recognized by medical device regulators. For example:
- The IEC 60601 series is widely recognized as the fundamental safety standards for medical electrical equipment.
- IEC 62366 has established a broadly recognized process model for achieving and validating optimal usability of devices.
- ISO 13485 is widely accepted for establishing conformity with quality system requirements to demonstrate the consistent delivery of the medical device that has been approved by the regulatory authority.
- The ISO 10993 series has the global standards for demonstrating the biological safety and compatibility of materials used in medical devices.
- The sterilization standards developed by ISO/TC 198 are utilized globally for ensuring the sterility of healthcare products.
- ISO 14971, which was jointly produced by ISO/TC 210 and IEC SC 62A, has become the benchmark for a medical device risk management process.
Although the medical device industry is highly regulated, global manufacturers clearly benefit from the reduction in trade barriers when countries agree on common approaches to meeting the regulatory requirements.
- Quality management systemsRequirements for regulatory purposes
- Part 1: Evaluation and testing within a risk management process
- Application of risk management to medical devices