European Market Entry

Validate Your Medical Device to European Union Product Requirements

Before a medical device can be sold in the European market it must meet the requirements of relevant New Approach Directives, such as the Medical Devices Directive (MDD). As a Notified Body for CE Marking, we can issue device-specific EC Certificates for your Class Is, Im, Class IIa, Class IIb, or Class III device. In fact, we have three Notified Bodies to the MDD located in the EU:

  • Intertek, United Kingdom, N/B No: 0359
  • Intertek Semko AB, Sweden, N/B No: 0413
  • Intertek ACSL, United Kingdom, N/B No: 0473

CE Marking – To access European markets, your medical device must meet the requirements of relevant product directives.

 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 1372 370900
Mexico
+52 55 5998 0900
S. AMER:
+55 11 2842 0444
APAC:
+86 400 886 9926
EMEA:
+46 8 750 0000
Germany
+49 711 27311 152