Riboflavin 93/42/eec
Webb21 maj 2024 · 93-42-EEC(中文版).pdf,欧盟理事会指令 理事会指令(1993 年6 月14 日) 关于医疗设备的指令(93/42/EEC ) 欧共体理事会: 考虑到建立欧洲经济共同体的条约,特别是其第100a 条, 考虑到委员会的提案, 以及与欧洲议会的合作, 考虑到经济和社会委员会的意见, 鉴于应就内部市场采取一些措施;鉴于 ... Webb5 maj 2015 · La directive Européenne 93/42/CEE relative aux dispositifs médicaux (DM) est applicable par tous les États membres de l’union, elle précise les rôles et obligations des différents acteurs du DM. Cet article, à destination des fabricants, présente les principaux points de la directive.
Riboflavin 93/42/eec
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Webb適用於歐盟醫療器材上市要求的歐盟醫療器材法規(MDR)自2024年5月26日起正式實施,取代歐盟醫療器材指令(MDD)93/42/EEC修訂版。 適用於歐盟醫療器材上市要求的歐盟醫療器材法規(MDR)自2024年5月26日起正式實施,取代歐盟醫療器材指令(MDD)93/42/EEC修訂版。 適用於歐盟醫療器材上市要求的歐盟醫療器材法 … Webb5 mars 2024 · Use in medical devices, within the scope of Directives 90/385/EEC*, 93/42/EEC* or 98/79/EC** in the case of substances that are subject to authorisation only because of hazards to human health (Art. 60(2) and 62(6) REACH) * Council Directives 90/385/EEC and 93/42/EEC will be mainly repealed and replaced by the
Webb14 juni 1993 · Medical Device Directive – MDD. Recitals. Article 1 — Definitions, scope. Article 2 — Placing on the market and putting into service. Article 3 — Essential … Webb2 jan. 2024 · Directive 93/42/EEC concerning medical devices WHAT IS THE AIM OF THE DIRECTIVE? It aims to ensure a high level of protection for human health and safety and …
WebbDirective 93/42/EEC and be subject to a consultation of a pharmaceuticals authority in accordance with point 7.4 of Annex I of Directive 93/42/EEC (see Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, version 1.3 (2.12.2008) chapter 7.3). WebbDirective 93/42/EEC (MDD) Status ANNEX V Version Directive 93/42/EEC (MDD) Status view on EUR-LEX Version Loading preview Recitals; Article 1 — Definitions, scope; Article 2 — Placing on the market and putting into service; Article …
Webb2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, last amended by Directive 2007/47/EC. 3. ISO/FDIS 14155:2010 Clinical investigation of medical devices for human subjects – Good clinical practice 12 in line with Annex 7.2.3.5 of Directive 90/385/EEC and Annex X.2.3.5 of Directive 93/42/EEC
Webb3 maj 2024 · MDR将取代Directives 90/385/EEC (有源植入类医疗器械指令)and 93/42/EEC(医疗器械指令)。 依据MDR Article 123的要求,MDR于2024年5月26日正式生效,并与2024年5月26日期正式取代MDD(93/42/EEC)和AIMDD(90/385/EEC)。 MDR实施之后,在三年过渡期内仍然可以按照MDD和AIMDD申请CE证书并保持证书的有效性。 … ron burgundy hoorayWebb1 aug. 2024 · mdcg 2024-6 法规(eu)2024/745:之前根据指令93/42/eec或90/385/eec进行ce标记的医疗器械所需提供的临床证据 ron burgundy imagesWebbShort name: Medical devices. Base: Regulation (EU) 2024/745 of the European Parliament and of the Council of 5 April 2024 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. OJ L 117 of 5 May 2024. Applicable from … ron burgundy i\u0027m a big dealWebb11 okt. 2007 · COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty … ron burgundy graphicWebbHarmonised standards under 93/42/EEC - Medical devices directive with relevance to COVID-19 2. Table indicating recognition of international standards under the legal … ron burgundy jack johnson clipWebb欧盟(CE)MDD_93-42-EEC医疗器械指令 发布时间:2014-07-17 10:30 发布方:弗锐达医疗器械咨询机构 浏览次数: 10218 第1条 定义、适用范围 1.本指令适用于医疗器械及其附件。 在本指令中,附件本身应被视为医疗器械。 医疗器械和附件以下均称为器械。 2.在本指令中,适用以下定义: (a) “医疗器械”是指制造商预定用于人体以下目的的任何仪器、 … ron burgundy leather bound books gifWebbCertifikatsinnehavare enligt LFVS 2003:11 ska uppfylla kraven i Direktivet 93/42/EEG om medicintekniska produkter samt tillämpa motsvarande krav i MDR (EU) 2024/745 … ron burgundy kind of a big deal gif