CE Marking We provide information to help organizations understand what is (European) CE Marking. Conformité Européene (CE) includes marking of European products; European Product Directives for import of products to the European Union, MDD and others including CMDCAS / MDSAP, for Canada 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. For CE Marking consult a European based Notified Body (NB).

    A must to read is ISO 13485 current revision Introduction 0.1 through 0.5 is extensive and provides for understanding an OEM and the freedom to chose suppliers, as the suppliers role within the medical supply-chain is covered such as CMOs (Contract Manufacturing Organizations). This is through the Introduction; 0.1 General, 0.2 Clarification of Concepts, 0.3 Process Approach, 0.4 Relationship with ISO 9001, and 0.5 Compatibility with other management systems. And matters such as MDF (Medical Device File) and "for regulatory purpose " within world regions such as those applying QSR and many similar other (e.g. Malaysia). 

We 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" as this does not hold true in many world regions.

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.




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