title: [The introduction of new medical devices].
abstract: Regulation of the introduction of new or improved medical devices is fundamentally different from that of new drugs and is inadequate in its current form. This was recently demonstrated by large-scale problems with medical devices in various specialist fields. Steps have been taken by scientific professional associations, regulating authorities and industry to prevent these problems from happening in the future. However, these steps have not yet been implemented or have not been sufficiently well implemented, and have not been completely coordinated. The practitioner therefore needs to remain extremely critical when using new medical devices.
authors: Leids Universitair Medisch Centrum, afd. Orthopedie, Leiden.
authors: Marc J
authors: MJ
authors: Nieuwenhuijse
authors: Rob G H H
authors: RG
authors: Nelissen
mesh_terms: D006801:Humans; D007883:Legislation, Medical; D009983:Orthopedic Equipment / Q000592:standards; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards*; D012308:Risk Management; D012449:Safety