EU Regulations & Directives
This section covers EU regulations and directives relevant to medical device compliance under the EU MDR framework. These include both the core MDR/IVDR and other cross-cutting EU legislation that medical device manufacturers must consider.
Core Regulations
| Regulation | Title | Status | Application Date |
|---|---|---|---|
| eu-mdr-2017-745 | Regulation (EU) 2017/745 on Medical Devices | active | 2021-05-26 |
| eu-ivdr-2017-746 | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices | active | 2022-05-26 |
| eu-mdr-amendments | EU MDR/IVDR Amendments Summary | active |
Related EU Regulations & Directives
The following EU legislation intersects with MDR compliance requirements:
| Regulation | Short Name | Relevance to Medical Devices | EUR-Lex |
|---|---|---|---|
| Directive 2011/65/EU (RoHS 2) | RoHS 2 | Restriction of the use of certain hazardous substances in electrical and electronic equipment | Full Text |
| Regulation (EC) No 1907/2006 (REACH) | REACH | Registration, Evaluation, Authorisation and Restriction of Chemicals | Full Text |
| Regulation (EC) No 1272/2008 (CLP) | CLP | Classification, Labelling and Packaging of Substances and Mixtures | EUR-Lex |
| Directive 2012/19/EU (WEEE) | WEEE | Waste Electrical and Electronic Equipment | Full Text |
| Council Directive 2013/59/Euratom | Council Directive 2013/59/Euratom | Basic safety standards for protection against the dangers arising from exposure to ionising radiation | Full Text |
| Regulation (EU) 2023/1542 (Battery Regulation) | Battery Regulation | Regulation concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020, repealing Directive 2006/66/EC | Full Text |
| Regulation (EU) 722/2012 (TSE) | TSE | Concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin | Full Text |
| Regulation (EU) 2024/2847 (Cyber Resilience Act) | Cyber Resilience Act | Regulation on horizontal cybersecurity requirements for products with digital elements (CRA) | Full Text |
| Directive (EU) 2022/2555 (NIS2) | NIS2 | Directive on measures for a high common level of cybersecurity across the Union (NIS 2 Directive) | Full Text |
| Regulation (EU) 2024/1689 (AI Act) | AI Act | Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) | Full Text |
| Regulation (EU) 2023/988 (GPSR) | GPSR | General Product Safety Regulation | Full Text |
| Regulation (EU) 2024/1781 (ESPR) | ESPR | Regulation establishing a framework for setting ecodesign requirements for sustainable products (Ecodesign for Sustainable Products Regulation) | Full Text |
| Regulation (EU) 2025/40 (PPWR) | PPWR | Regulation on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC | Full Text |
| Directive 2014/53/EU (RED) | RED | Radio Equipment Directive - harmonisation of the laws of the Member States relating to the making available on the market of radio equipment | Full Text |
| Regulation (EU) 2023/1230 (Machinery Regulation) | Machinery Regulation | Regulation on machinery and repealing Directive 2006/42/EC | Full Text |
| Directive 2001/83/EC (Medicinal Products) | Medicinal Products | Directive on the Community code relating to medicinal products for human use | Full Text |
| Directive (EU) 2022/2557 (CER Directive) | CER Directive | Directive on the resilience of critical entities | Full Text |
Fulltext Availability
Where available, regulation full texts are extracted from EUR-Lex and can be viewed directly. Click the "Full Text" link to access the complete regulatory text.