動物由来の原材料を組み込んでいる医療機器に対するEU要求事項 （英語）

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Regulation for medical devices incorporating animal products in the European Union

Modern medical devices incorporate a range of materials into finished products, including in some instances animal tissues and other materials of animal origin. Although animal materials can provide therapeutic and biocompatibility advantages over non-animal materials, their use in medical devices also introduces the risk of disease transmission from animals to humans. Most notable is the potential transmission of transmissible spongiform encephalopathy (TSE), a debilitating disease affecting the brains of susceptible species, including cattle, sheep and goats, and which can be transmitted to humans through contact with TSE-infected animal tissues and fluids.

Register for professional training management on the New EU Regulation No. 722/2012 by TÜV SÜD Akademie here 

European Union regulations

In response to increasing concerns about disease transmission from medical devices incorporating animal products, the Commission of the European Union (EU) published the so-called TSE Directive (2003/23/EC) in 2003. In support of this Directive, the Commission has recently issued revised regulations (722/2012) regarding the use of TSE-relevant animal tissues and products found in a wide range of medical devices. The new regulations impose additional compliance requirements on medical device manufacturers, including rigorous risk assessment and risk management practices intended to reduce the potential risk of TSE transmission.

For manufacturers, the requirements of the EU’s Regulation 722/2012 are applicable to any device approved for placement on the market as of August 29, 2013. Devices approved prior to August 29, 2013 may remain on the market until August 29, 2014. However, manufacturers of these devices must apply to their Notified Body for a design-examination or type examination certificate that attests to the manufacturer’s compliance with the requirements in Annex 1 of the Regulation.

To assure compliance with the provisions of the EU’s Regulation regarding medical devices that incorporate materials of animal origin, manufacturers should consult with a Notified Body at the earliest possible stages of new product development to determine how these requirements will impact design considerations. Further, manufacturers should consider evaluating existing medical devices for compliance with the new requirements well ahead of the August 2014 deadline. Taking these steps can help to ensure an efficient conformity assessment and product approval.

Why choose TÜV SÜD

TÜV SÜD Product Service scientific and technical experts have been directly involved in the EU’s TSE working group to develop regulations and standards applicable to medical devices incorporating materials of animal origin. TÜV SÜD Product Service experts have also worked with the Technical Committee responsible for ISO 22442, Medical devices utilising animal tissues and their derivatives - Part 1: Application of risk management. TÜV SÜD Product Service has extensive experience in the testing and certification of all types of medical devices, including those incorporating materials of animal origin.

Our services at a glance

• Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
• Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conduct thousands of in-depth risk management audits each year.
• GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
• Other testing and certification services - In addition to testing and certifying medical devices for compliance with EU Regulation 722/2012, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.

Your benefits at a glance

• Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
• Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
• Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
• Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.