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