European Regulations and Directives

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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 (1,80 MB) »

EC Proposal Progressive roll-out of IVDR October 14, 2021 Download (305 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) »

Commission implementing regulation 2020/1207: common specification for reprocessing single-use MD August 2020 Download (558 KB) »

Commission Implementing Decision 2021-1182 on the harmonised standards for med. dev. (MDR) 16 July 2021 Download (370 KB) »

Commission Implementing Decision 2021-1195 on the harmonised standards for IVD-MD (IVDR) 19 July 2021 Download (474 KB) »

Other Directives and Regulations

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 2020-02-27 Download (4,67 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 2020-05-01 Download (551 KB) »

Directive 2006/42/EC on Machinery Consolidated version 2019-07-26 Download (850 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) Consolidated version 2012-07-01 Download (795 KB) »

Commission Decision 2009/886/EC amending Decision 2002/364/EC on CTS for IVD 2009-12-01 Download (90 KB) »

Commission Implementing Decision 2019/1244 amending Decision 2002/364/EC Requirements for HIV and HCV antigen and antibody combined tests and requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays Download (382 KB) »

Commission Implementing Decision 2020/350 amending Decision 2002/364/EC Definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays Download (522 KB) »

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European Regulations and Directives