Sorrel S
MedPass International, Paris, France.
Med Device Technol. 1998 Sep;9(7):43-7.
The absence of a pan-European regulatory framework for medical devices incorporating human tissues is causing difficulties for the growing number of manufacturers of these products. France has implemented strict legislation in this area and is spearheading an effort for Member States to adopt similar measures. This article looks at the status of French regulations, which form the basis of its recent proposal to the European Commission for a new Directive on human tissues.
缺乏一个针对包含人体组织的医疗设备的泛欧监管框架，给越来越多生产此类产品的制造商带来了困难。法国已在这一领域实施了严格的立法，并带头推动成员国采取类似措施。本文探讨了法国法规的现状，这些法规构成了法国最近向欧盟委员会提交的关于人体组织新指令提案的基础。
