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.

If you want to receive document updates and other regulatory news immediately in your mailbox, subscribe to our newsletter!

Other libraries

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) »

Regulation 2022/112 (amends IVDR) - transitional provisions for certain IVD and in-house devices January 25, 2022 Download (505 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) »

Implementing Regulation 2021/2078 on the application of MDR regarding EUDAMED November 2021 Download (418 KB) »

Implementing Regulation 2021/2226 on the application of MDR regarding eIFU December 2021 Download (422 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) »

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

European Regulations and Directives