We provide information to help organizations understand what is CE Marking. CE includes Product Directives for exports to the European Union, MDD and others including CMDCAS, through ISO 13485 and product specifics + FDA cGMP QSRand other relevant requirements. Also, in addressing requirements for Latin America visit our CE Mark page in Spanish where there is a reference-list of devices, Latin American Regulations page, for information on equipment and other devices and applicable exports to the European Union and additional data.

We strive to provide answers to questions assisting organizations to understand CE and other regions requirements (UL, CSA, BRS...). Our experience derives from organization such as GE Medical Systems, Kimberly-Clark Professional Health Care, Kappler, ITL Australasia and many others... Be careful with the mere selling phrase "certify once and accept everywhere".

For medical devices, MDD may be combine for product registration concurrent with FDA GMP QSR compliance, to the technical intricacies that medical devices may bring (from design through testing, packaging and shipping and for attaining CE Marking).

Visit FDA GMP QSR. Visit also our CE Marking table (while numerical text is in Spanish). The table therein provides a list of devices and specific applicable standards.