From directives to regulations

摘要

A European Commission (EC) review of the Medical Device Directives has resulted in a proposal for a new regulation to replace both Directive 90/385/EEC (active implantable medical devices) and Directive 93/42/EEC (medical devices), with a separate regulation to replace Directive 98/79/EC (in vitro diagnostic medical devices). Jean-Louis Evans, managing director at TUV SUD Product Service, helps to clear things up.