You manufacture active medical devices intended to remain permanently in the body. These AIMDDs are only allowed on the European market if they comply with the Active Implantable Medical Device Directive (90/385/EEC).

KEMA has been officially designated to implement the complete conformity assessment of the AIMDD for access to the EU market.  KEMA is also accredited to grant access to markets in other countries. Moreover, you can call on KEMA for certification of your Quality System. 

KEMA: One-stop shopping!

• KEMA keeps your time to market as short as possible and has developed a special program for this.
• KEMA has a global presence. 
• In addition to the AIMD Directive, you can also call on KEMA for such things as IEC 601 tests, R&TTE, 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.  
• Dissatisfied with the service you receive from your present Notified Body? KEMA has experience in assuming certificates. 
• You have one permanent contact throughout the entire process.
• KEMA participates in all the MRAs (i.e. US, Japan, Taiwan, Australia). 
• KEMA is an expert in drug/device combinations and products with animal material.                   

For more information please contact us.

For Notified Body Recommendations click here.

Guidelines relating to medical devices Directives (MEDDEV documents).