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European Regulations and Directives

European Regulations and Directives

European Regulations and Directives

Library

Hereunder, you can download the European Regulations and Directives that are relevant for Medical Devices and In Vitro Diagnostic Medical Devices.

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Principal Regulations: IVD and MD

European Regulation 2017/746 on In Vitro Diagnostic Medical Devices Published May 5, 2017 - Consolidated version Download (884 KB) »

European Regulation 2017/745 on Medical Devices Published May 5, 2017 - Consolidated version Download (997 KB) »

Principal Directives: IVD, MD and AIMD

European Directive 98/79/EC on In Vitro Diagnostic Medical Devices Consolidated version 2012 Download (400 KB) »

European Directive 93/42/EEC on Medical Devices Consolidated version 2007 Download (270 KB) »

European Directive 90/385/EEC on Active Implantable Medical Devices Consolidated version 2007 Download (158 KB) »

Implementing Regulations and Decisions

Implementing Regulation 2017/2185 on Notified Body designation codes November 2017 Download (627 KB) »

Implementing Decision (EU) 2019/939 Designating Issuing Entities for the Assignment of UDIs June 2019 Download (370 KB) »

Commission Implementing Regulation 920/2013 on the Designation & Supervision of NBs under AIMDD & MD 2013 Download (789 KB) »

Other Directives and Regulations

EU Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures Consolidated version 2018-03-01 Download (16,98 MB) »

EU regulation 207/2012 on electronic Instructions for Use of Medical Devices March 2012 Download (725 KB) »

Commission Regulation 722/2012 on AIMD and MD manufactured utilising tissues of animal origin August 2012 Download (761 KB) »

Regulation 1907/2006 on Registration, Evaluation, Authorization & Restriction of Chemicals (REACH) Consolidated version 2018-05-09 Download (3,91 MB) »

Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) Consolidated version 2018-07-04 Download (592 KB) »

Directive 2011/65/EU RoHS on restriction of use of hazardous substances in electronic equipment Consolidated version 2018-07-06 Download (422 KB) »

Directive 2006/42/EC on Machinery Consolidated version 2016-04-20 Download (718 KB) »

Commission Recommendations

Commission Recommendation 2013/473/EU on the audits and assessments performed by NB for MD 2013 Download (743 KB) »

Commission Recommendation 2013/172/EU on common framework for unique device identification system 2013 Download (763 KB) »

Common Technical Specifications

Commission Decision 2002/364/EC on Common Technical Specifications for In Vitro Diagnostics (CTS) 2002 Download (795 KB) »

Don't hesitate to contact us if you need help with the interpretation with one of these documents!

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