Will Keymark usurp EMEDCA (European Active Medical Device Certification Agreement voluntary certification scheme)?
This article was originally published in Clinica
Executive Summary
The future of EMEDCA, the European Active Medical Device Certification Agreement voluntary certification scheme, would be uncertain if parallel developments within CEN and CENELEC were to attract medical device industry support. Industry is now being invited to consider a new scheme which could, in theory, introduce voluntary certification in the non-active medical device sector for the first time as well as the active device sector.