The Coalition works with industry and governments around the world to minimize regulatory-related barriers between patients and life-saving and life-improving medical technologies.
Central to this work is global medical device regulatory convergence. Regulatory convergence is the process of aligning the technical regulations, standards, and conformity assessment criteria for medical devices in all countries toward a single set of internationally harmonized criteria.
The World Health Organization urges public health authorities around the world to economize their limited public health resources by relying on international standards as a basis for national regulations and by relying on the conformity assessment results of other jurisdictions. The government funds required to develop a regulation in isolation, to test a product that has already been tested, or to certify a product that has already been certified are funds that a health agency can use to strengthen post-market surveillance, to digitize import review procedures, to accelerate good manufacturing practice inspections, to modernize IT infrastructure, or to upgrade regulatory inventory. More broadly, such economized public health resources can be used to improve healthcare delivery by hiring and training physicians, nurses, and procurement staff; by investing in hospitals, clinics, and other points of care; by upgrading health IT systems, and to otherwise improving patient treatment and care delivery.
The documents listed below summarizes the primary international reference documents for medical device regulators regarding regulatory convergence and the use of international standards.
4.2 Basic-level controls and their enforcement (page 23)
188.8.131.52 – “…The preferred, but optional, way by which the manufacturer may demonstrate conformity with the Essential Principles is to apply voluntary international standards that are appropriate and relevant. The law should include provisions allowing the regulatory authority to formally recognize such standards for that purpose (see section 184.108.40.206)…”
220.127.116.11 – “…At the expanded level, the regulatory authority may wish to establish a procedure to identify national versions of international standards that it accepts as providing presumption of compliance to specific Essential Principles, i.e. “recognized standards”. Preference for recognition should be given to international standards, e.g. those of the International Organization for Standardization (ISO)and the International Electrotechnical Commission (IEC), regional standards and the national versions of international standards. It is also important that national standards correspond to the current version of international standards. As international standards are periodically revised, national standards will have to be revised accordingly and the authority should establish a transition period for manufacturers to adopt the new versions. To maintain the necessary flexibility in utilizing standards, it is better to adopt a system of recognizing standards through guidance documents or guidelines than placing the standards into legislation; they can then be updated to stay current and can be revised much faster than legislation can be updated.
(page 272) “A sound legal framework, adoption of international norms and standards and recruitment and development of competent staff are necessary but not sufficient conditions to ensure “good regulatory oversight”. These measures must be combined with good regulatory practices (GRP) that guide all individuals in organizations entrusted with regulating medical products in formulating decisions that are clear, transparent, consistent, impartial, proportionate, timely and based on sound science and legislation.”
(page 275) “Regulatory convergence. A voluntary process whereby the regulatory requirements in different countries or regions become more similar or “aligned” over time. Convergence results from gradual adoption of internationally recognized technical guideline documents, standards and scientific principles, common or similar practices and procedures or the establishment of appropriate domestic regulatory mechanisms that align with shared principles to achieve a common public health goal.”
(page 277) “Increasingly, policy-makers and regulatory authorities are adopting modern models of regulation that are responsive to resource constraints while meeting the challenges posed by scientific development, globalization, rising public expectations and public health emergencies. Weak or inefficient regulatory systems can limit access to safe, effective and, high quality medical products and pose a threat to public health. As countries strengthen their regulatory capacity, they must ensure that their regulatory systems are science-based, that they adhere to international standards and guidelines and that their approach leverages the work of other, trusted regulatory authorities and institutions when possible. To this end, countries are encouraged to formulate and implement policies and strategies that promote international collaboration, convergence, harmonization, information- and work-sharing and reliance as part of GRP. WHO is establishing a framework for evaluating NRAs and regional regulatory systems and for designating those that meet the requirements of WHO listed authorities.”
(page 284) “All regulatory authorities must be accountable to the public, the bodies they regulate and the government for their actions and decisions as part of good governance and accountability. In the context of GRP, regulatory authorities are accountable when they are: (i) responsible for acting according to certain standards and commitments, (ii) answerable for their actions and (iii) willing to face the consequences when standards or commitments are not met.”
(page 291) “International guidelines and standards should always be considered in developing new guidance documents, and regulators should support international harmonization and convergence. National requirements beyond international standards should be well justified.”
(page 293) “Terms should be defined in order to avoid ambiguity or misinterpretation. When possible, they should be consistent with established international norms, standards and harmonized guidelines. As noted previously, international standards and guidelines are particularly important vehicles for promoting common regulatory language, convergence and international cooperation.”
(page 293) “Regulations and supporting guidelines should be reviewed periodically to ensure that they reflect the authority’s current practices and expectations, are adapted to scientific and technological developments and are aligned with current international standards and guidelines, when applicable. Review and revision of a guideline should include consideration of the consequential changes in other guidelines, which should be revised simultaneously.”
(page 301) “Regulatory decisions and decision-making should be based on scientific foundations and accurate data rather than intuition or arbitrariness. Science-based decisions provide for consistent, predictable regulatory outcomes. Adherence to international standards and guidelines is a key enabler of science based regulatory decision-making.”
(page 250) “Equally, the authorities being relied upon should have and maintain competence and operate within a robust, transparent regulatory system based on international standards and guidelines, as well as GRP, and a well-functioning quality management system.”
(page 251) “NRAs that practise reliance should establish and publish a list of reference regulatory authorities, with the criteria used in identifying them. They should decide and establish the criteria they will use for selecting reference authorities, such as application of international standards, long standing recognition in the international community, proximity and commonality of medical products.”
(page 255) “Convergence and harmonization of requirements, standards and guidelines are important enablers of regulatory cooperation and reliance. The more similar requirements, standards and guidelines are, the greater the opportunity for collaboration and reliance…”
“…Differences in standards and practices, however, do not prevent one authority from relying on another, particularly when the relying authority has limited capacity and expertise. The system on which an NRA relies should be at least equivalent to or superior to the standards it applies. As a matter of good practice, NRAs should rely on assessments or decisions from reference regulatory authorities that apply international standards and guidelines.”
(pages 1-2) “Recent horizontal International Organization for Standardization (ISO) standards for medical devices place increased emphasis on the importance of post-market surveillance. The ISO standard on quality management systems (QMS) for medical devices, used by most manufacturers, requires a post-market surveillance system to be in place. Furthermore, in the 2019 revision of the ISO standard on risk 1 management of medical devices requirements on post-market surveillance were also strengthened. The specific ISO guidance document on post-market surveillance for manufacturers of medical devices was recently published. Together, these documents provide a framework for conducting post-market surveillance and using post-market surveillance data to ensure the continued quality, safety and performance of medical devices.”
(page 45) “NRAs should apply international standards in force for the respective category of medical devices.”
2a. IMDRF N47 – “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”
Annex A: Use of Standards in Meeting Essential Principles
B. Use of Standards by Regulatory Authorities having Jurisdiction “These standards should, wherever possible, be standards incorporating the thinking of the global marketplace and help support the development of consistent expectations between Regulatory Authorities having jurisdiction. In the absence of international consensus standards, it may be appropriate for Regulatory Authorities having jurisdiction to accept the use of regional or national consensus standards or industry standards.”
2b. IMDRF N51 – “Optimizing Standards for Regulatory Use”
B. Use of Standards by Regulatory Authorities having Jurisdiction 1.2 Role of standards in regulatory processes Although regulatory processes among IMDRF regions differ, RAs [regulatory authorities] share the common objectives to ensure medical device safety and performance and to protect public health. International consensus standards are based upon science, technology and experience and generally reflect the best experience of industry, researchers, consumers, regulators and other experts worldwide. IMDRF members affirm their collective belief that reliance upon consensus standards is a key element of a robust regulatory framework. Appropriate use of standards will promote efficiencies and innovation while facilitating objective assessment of device safety and performance.”
International Trade Obligation
World Trade Organization – Agreement on Technical Barriers on Trade
Article 2.4 – “Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations…”
ISO Guidance on use of International Standards
ISO Guide 21-1 “Regional or national adoption of International Standards and other International Deliverables — Part 1: Adoption of International Standards”
0.2 International Standards are widely adopted at the regional or national level and applied by manufacturers, trade organizations, purchasers, consumers, testing laboratories, authorities and other interested parties. Since these standards generally reflect the best experience of industry, researchers, consumers and regulators worldwide, and cover common needs in a variety of countries, they constitute one of the important bases for the removal of technical barriers to trade. This has been explicitly acknowledged in the Agreement on Technical Barriers to Trade of the World Trade Organization (WTO TBT Agreement).
It is important that every effort be made to adopt and use International Standards as regional or national standards and, consequently, to withdraw conflicting regional or national standards as soon as practicable for the reasons mentioned above. Only by developing a global approach can the benefits of standardization be fully realized. However, full adoption may not be practicable in all cases for reasons such as regional or national security, protection of human health or safety, or protection of the environment, or because of fundamental climatic, geographical or technological problems. The WTO TBT Agreement recognizes that these are legitimate reasons for regional or national deviations.
0.3 The adoption of an International Standard as a regional or national standard will be extremely difficult if the regional or national rules or traditions concerning structure and layout of regional or national standards differ from those of the standard being adopted. It is therefore recommended to apply, as far as possible, the ISO/IEC Directives, Part 2, for the preparation of regional and national standards.
Even for the cases referred to in 0.2, every effort should be made to reduce the deviations to a rational minimum. Moreover, where deviations from International Standards exist, it is important to identify the deviations clearly and to state the reasons for the deviations. If International Standards are adopted only by means of a re-edited version, it is extremely difficult to identify the technical deviations owing to the presentation differences (that is differences in the structure and wording) of the original standard. On the other hand, a clearly identified deviation will have a tendency to disappear because as long as it remains visible, the question as to whether it is still necessary will arise repeatedly, while a hidden deviation may not disappear even when no longer justified.
0.4 It is recommended that as much information as possible be given about the correspondence of regional or national standards that adopt International Standards (or are based on them). This information should be displayed in a prominent place on the regional or national standard (preferably on the title page and in the foreword), in standards lists, catalogues, year-books and any other media for retrieval purposes. When quoting an International Standard, at least its number and date of publication should be given. If a regional or national standard does not exist materially (for example, if the International Standard has been adopted by the endorsement method), this information about correspondence should be given in standards listing media as mentioned above.”
Using ISO and IEC standards to support public policy