Reference Documentsand Revision Dates Another useful page under the breadth of the European Commi

Reference Documentsand Revision Dates

Another useful page under the breadth of the European Commission website is a page that organizes the reference documents relevant to device manufacturers. Full text documents of current legislation are available for download, the most useful of which for medical device manufacturers is the EU’s Medical Device Directives, though the In-Vitro Diagnostic Device Directive and Active Implantable Medical Device Directive also are available. Implementing legislation, which includes Eudamed (the European Databank on Medical Devices) and technical specifications on in-vitro diagnostics are delineated. Classification documents, the MEDDEVs (Medical Device Directive guidelines), consensus statements, standards and others also are centrally located on this page.

The strengths of this page come from its explicit organization, reference of revision dates, and the linking of documents as well as their public accessibility.