Tissues of Animal Origin Directive (2003/32/EC).

You manufacture medical devices using tissues of animal origin. This tissue is only allowed on the European market if it complies with the Tissues of Animal Origin Directive (2003/32/EEC) in combination with the Medical Device Directive.

For access of medical devices to the European Union and associated countries (EEA), KEMA provides necessary CE
certification under the Medical Device Directive, the Active Implantable Medical Device Directive, the R&TTE and the In Vitro Diagnostic Medical Device Directive. KEMA covers the full scope under these directives, including medical devices containing material from animal origin and material from human blood origin.

KEMA: One-stop shopping

• KEMA has a global presence
• All your testing and certificates at one institute: In addition to the Tissues of Animal Origin Directive (2003/32/EEC), you can also call on KEMA for MDD, 510(k) reviews, and ISO 13485
• Specialists with extensive experience in the medical industry assess your products
• KEMA keeps the time to market as short as possible thanks to a special program
• Dissatisfied with the service you receive from your present Notified Body? KEMA has experience in assuming certificates.

More information? Contact us.