You produce medical devices for In Vitro diagnosis. These devices are only allowed on the European market if they comply with the In Vitro Diagnostic Medical Device Directive (IVDD97/98/EEC).

KEMA has been officially designated to implement the conformity assessment of the IVDD 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 has a global presence. 
• In addition to the In Vitro Diagnostic Medical Device Directive, 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.
• 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).