Premarket elements of the plan as described in the final indent of MDR Annex XIV Section 1a (first-in-man studies, feasibility and pilot studies) are not generally relevant to legacy devices which are unchanged in design or indications. However, the context for the plan as described in indents...
12个AnnexAnnex中规定了医疗器械的基本要求(Annex I)认证模式(Annex II~Annex VIII)分类(Annex IX)临床(Annex X)指定机构的准则(Annex XI)CE合格标识(Annex XII)公告机构:93/42/EEC需要公告机构来完成认证。公告机构是一个由欧盟某个成员国的主管当局指定的测试、审核和认证机构,它可从事医疗器械指令的附录中所...
医疗器械指令 93-42-EEC_2007完整版中英文对照.docx,COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 1993 年 6 月 14 日理事会第 93/42/EEC 号指令 concerning medical devices 关于医疗器械 更改历史记录: z M1 Directive 98/79/EC of the European Parliament and of the
MDD_93_42_EEC(amended_by_2007_47_EC)中英对照版
Medical equipment companies are evaluated according to Directive 93/42 / EEC Annex II and can also be evaluated according to one of Annex VII and Annex IV or Annex V, Annex VI. 3. IIb medical device Example: X-ray diagnostic equipment, blood bag, Insuline pump, electronic operating machine...
Annex X,and to implement appropriate means to apply any necessary corrective action.This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:? (i)any malfunction or deterioration in the characteristics...
求翻译:EC Directive 93/42/EEC Annex V,Article 3 Quality Assurance System是什么意思?待解决 悬赏分:1 - 离问题结束还有 EC Directive 93/42/EEC Annex V,Article 3 Quality Assurance System问题补充:匿名 2013-05-23 12:26:38 EC 指令 93年/42/EEC 附件五,第 3 条质量保证体系热门...
Commission Regulation (EEC) No 2868/93 of 20 October 1993 amending Annex X to Regulation (EEC) No 3587/86 fixing the conversion factors to be applied to the buying-in prices for fruit and vegetables as regards applesdoi:31993R28681993年10月20日第2868/93号委员会法规(EEC)修订了第3587/86号...
11 (g) The Company agrees that, other than the Issuer Free Writing Prospectus identified on Annex A as forming part of the Time of Sale Information or prepared pursuant to Section 2(d) or Section 4(c) above, without the prior consent of the Representatives, it has not made and will ...
shall be kept by the competent authority for a period of at least three years from the date of the checks, including a copy of the corresponding record sheet or print-out as referred to in Annex I or Annex IB to Regulation (EEC) No 3821/85 if the vehicle is covered by that ...