Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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5 The Global Framework for Regulation of Medical Devices
5 The Global Framework for Regulation of Medical Devices
Pages 35-52
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From page 35... ...
Comparative Overview of Medical Device Regulatory Systems David Jefferys, a medical device expert and senior vice president for global regulatory, health-care policy, and corporate affairs at Eisai Europe, Ltd., provided an overview of European device regulations and discussed some of the key procedures in Japan, China, and India and how they differ from current operations in the United States. European Regulations In Europe, four directives cover the medical device sector.
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From page 36... ...
The legislation establishes "notified bodies" to evaluate devices and "competent authorities," which are the agencies that control clinical trials, designate and supervise the notified bodies, and oversee postmonitoring surveillance. The legislation itself is underpinned by "normative standards." Some are European standards, others are International Organization for Standardization (ISO)
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From page 37... ...
Another role of a competent authority is compliance and enforcement, ensuring that the Medical Devices Act is being complied with and potentially prosecuting anyone who places a device on the market without authorization or a device that is inappropriately labeled. A competent authority also supervises class I devices.
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From page 38... ...
The notified body lives with the product and with any variations or change in the product, and it is involved if there are any vigilance problems. Many of the notified bodies play an international role, are qualified under the Conformity Assessment Body system to bring a product into the United States, and have a role in the systems in China and Japan.
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From page 39... ...
However, if the device and the medicinal product form an integrated element, the product will be covered under the pharmaceutical law, for example, prefilled injectors, such as the EpiPen, in which it is clear that the device is to be used only once for delivering the pharmaceutical product contained. Some combination products are medical devices that incorporate a pharmaceutical substance with an ancillary action, for example, drugeluting stents.
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From page 40... ...
The Committee for Advanced Therapies has been established and reports to the Committee on Human Medicinal Products in the European Medicines Agency. borderline Products As in the United States, regulations cover medical devices, pharmaceuticals, advanced therapy products, cosmetics, biocides, personal protective equipment, and foods and nutraceuticals.
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From page 41... ...
Using the GHTF principles, the third-party assessors use the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) for the product application.
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From page 42... ...
; GHTF has memoranda of understanding with the ISO and the International Electrotechnical Commission, and it works directly with the World Health Organization and the Pan American Health Organization. The purposes of the GHTF were to encourage convergence in global regulatory practices and to promote technologic innovation and international trade through harmonized regulatory processes.
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From page 43... ...
Other basic subjects include technical requirements, format and content of marketing applications, assessment and review practices, postmarket activities, and quality-management system requirements and auditing functions. Ad hoc working groups have been established on medical device software, combination products, training, the global regulatory model, global medical device nomenclature, unique device identifiers, and improvement of GHTF administrative processes.
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From page 44... ...
But there is a commitment from the members of the GHTF steering committee toward convergence of their regulatory systems as much as possible with the principles of the GHTF regulatory model. Another challenge is related to conformity assessment vs type testing.
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From page 45... ...
The goal of developing the scorecard is to inform all medical device industry stakeholders about why the innovation model for medical devices is unique. The project, sponsored by PwC, was announced in spring 2009 at an international conference in Rome, and it is expected to be completed in fall 2010.
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From page 46... ...
One question that is being asked with regard to the regulatory environment, for example, is which regulatory and reimbursement environments are the most attractive for the introduction of innovative medical technologies. On access, the survey asks which countries are better equipped with the health-care and technologic infrastructure to deliver innovative medical technologies.
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From page 47... ...
began to address pharmaceutical harmonization, nearly all countries regulated drugs in some way, but when the GHTF began, 80 countries had no device regulatory scheme whatsoever. The GHTF process was more inclusive than that of the ICH, and its mission included helping countries to develop their medical device regulatory systems.
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From page 48... ...
But one has to remember that although a device may be regarded as being in a lower-risk category, for a variety of reasons, including user issues, the risks may still be great. Therefore, the European legislation makes it clear that the same degree of testing and the same requirements for clinical data are present, although for some the emphasis shifts from premarket regulation to postmarket surveillance.
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From page 49... ...
Differences between uS and Eu Risk-Classification Systems Class III devices are required to have a full design dossier, which will be fully evaluated; whether it is by a notified body or by FDA, the process is the same, and the postmarket requirements are the same. For class IIA and IIB in Europe, or class II in the United States, a manufacturer has to have a full design dossier and full quality-review systems.
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From page 50... ...
With regard to notifiable changes in a device, Jefferys said that in both the United States and Europe, the definition of a reportable change is difficult to determine. In Europe, a company is required to document every small change; a significant change must be reviewed by a notified body, and the design dossier must be updated.
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From page 51... ...
Feigal noted that FDA has the authority to require studies during the postmarket period, but it is not done very often. That, he said, could be looked at more systematically, specifically to determine types of products in class II that are more likely to need postmarket surveillance.
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