Be confident of medical device market approval
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.
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.
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.
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