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What are the EU Requirements for medical devices manufactured utilizing animal derived materials
Modern medical devices sometimes incorporate animal tissues and other materials of animal origin into finished products or are manufactured utilizing animal derived materials. Although animal derived 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. This can be transmitted to humans through contact with TSE-infected animal tissues and fluids, or TSE-contaminated materials.
In response to increasing concerns about disease transmission from medical devices incorporating animal products, the Commission of the European Union (EU) published the TSE Directive (2003/32/EC) in 2003. In support of this Directive, the Commission issued a new regulation (Regulation (EU) no 722/2012) in 2012 regarding the use of TSE-relevant animal tissues and products found in a wide range of medical devices. The new regulation requires the need for consultation with Competent Authorities for all devices, including those where a “TSE certificate of suitability” exists.
Medical device manufacturers 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 and that a review with the competent authorities of the Member States has taken place prior to the issuance of the certificate.
To ensure compliance with this regulation, manufacturers should consult with a Notified Body such as TÜV SÜD at the earliest stages of new product development. Further, manufacturers should consider evaluating existing medical devices for compliance with the requirements. Taking these steps can help to ensure an efficient conformity assessment and product approval.
In response to increasing concerns about disease transmission from medical devices incorporating animal products, the Commission of the European Union (EU) published the TSE Directive (2003/32/EC) in 2003. In support of this Directive, the Commission issued a new regulation (Regulation (EU) no 722/2012) in 2012 regarding the use of TSE-relevant animal tissues and products found in a wide range of medical devices. The new regulation requires the need for consultation with Competent Authorities for all devices, including those where a “TSE certificate of suitability” exists.
Medical device manufacturers 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 and that a review with the competent authorities of the Member States has taken place prior to the issuance of the certificate.
To ensure compliance with this regulation, manufacturers should consult with a Notified Body such as TÜV SÜD at the earliest stages of new product development. Further, manufacturers should consider evaluating existing medical devices for compliance with the requirements. Taking these steps can help to ensure an efficient conformity assessment and product approval.
How TÜV SÜD can support you with assessing medical devices manufactured utilizing animal derived materials
TÜV SÜD is one of the world’s largest EU Notified Bodies for medical devices, with a global network of experts in major markets around the world, and an in-house Clinical Centre of Excellence. We have extensive experience in certification of all types of medical devices, including medical devices manufactured utilizing animal derived materials.
Our scientific and technical experts have been directly involved in the EU’s TSE working group to develop regulations and standards applicable to medical devices manufactured utilizing animal derived materials.
We have also worked with the Technical Committee responsible for ISO 22442, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD 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.
We are a comprehensive solution offering various services for major medical device markets according to international standards and regulations. We work with companies ranging from global manufacturers to regional and local firms.
Our scientific and technical experts have been directly involved in the EU’s TSE working group to develop regulations and standards applicable to medical devices manufactured utilizing animal derived materials.
We have also worked with the Technical Committee responsible for ISO 22442, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD 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.
We are a comprehensive solution offering various services for major medical device markets according to international standards and regulations. We work with companies ranging from global manufacturers to regional and local firms.
What our services for medical devices manufactured utilizing animal derived materials include
Product safety certification – TÜV SÜD Product Service is an EU Notified Body for medical devices and is recognized by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
