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.

Clinica  published an article about KEMA’s success as assessor of products with animal material.  The article is attached in a download below. 

KEMA: One-stop shopping!

• KEMA has a global presence. 
• In addition to the Tissues of Animal Origin Directive (2003/32/EEC), you can also call on KEMA for such things as MDD, 510(k) , and ISO 13485:2003. That makes a big difference in terms of time and money. One-stop shopping. All your testing and certificates at one institute: KEMA.
• 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.         

For more information please contact us. 

For Notified Body Recommendations click here.

Guidelines relating to medical devices Directives (MEDDEV documents).