Reigstad A
Statens senter for ortopedi, Avdeling Kronprinsesse Märthas Institutt, Oslo.
Tidsskr Nor Laegeforen. 1993 Nov 20;113(28):3475-7.
The "new approach" policy limits the European Community legislative harmonization to adopting essential safety requirements which medical devices brought on the market will have to meet, and thereafter obtaining free trade in the European market. A set of harmonized standards will explain in detail what the essential requirements mean in practice. Therefore, the work being done on standards for surgical implants by the European Committee for Standardization (CEN) is indispensable. The impact of the "New Approach" on the Norwegian legislation is discussed, and it is concluded that the Committee for Single-Use Medical Devices, which registers all surgical implants prior to marketing in Norway, will have to close down in 1995.
“新方法”政策将欧共体的立法协调限制在采用基本安全要求上，投放市场的医疗器械必须符合这些要求，此后在欧洲市场实现自由贸易。一套协调标准将详细解释这些基本要求在实际中的含义。因此，欧洲标准化委员会（CEN）在外科植入物标准方面所做的工作不可或缺。文中讨论了“新方法”对挪威立法的影响，并得出结论：挪威负责在所有外科植入物上市前进行登记的一次性使用医疗器械委员会将于1995年关闭。
