R&TTE Directive (99/5/EEC).

Access to the European market

You use radio equipment or telecommunications terminal equipment as a component in your active medical device. This equipment is only allowed on the European market if it complies with the R&TTE Directive (99/5/EEC).

KEMA has been officially designated to implement the conformity assessment of the R&TTE Directive (99/5/EEC) 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
  • All your testing and certificates at one institute: In addition to the R&TTE Directive (99/5/EEC), you can also call on KEMA for IEC 601 tests, 510(k) 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.
Rate This Page: