Regulatory References - Related International Standards
The following non-harmonised international standards are related to Regulatory References for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| Directive 2011/65/EU (RoHS 2) | Restriction of the use of certain hazardous substances in electrical and electronic equipment | active | 10, 10.4, 10.4.3 | Link |
| Regulation (EC) No 1907/2006 (REACH) | Registration, Evaluation, Authorisation and Restriction of Chemicals | active | 10, 10.4, 10.4.2, 10.4.3 | Link |
| Regulation (EC) No 1272/2008 (CLP) | Classification, Labelling and Packaging of Substances and Mixtures | active | 10, 10.4, 10.4.3, 23 | Link |
| Directive 2012/19/EU (WEEE) | Waste Electrical and Electronic Equipment | active | 23 | Link |
| Council Directive 2013/59/Euratom | Basic safety standards for protection against the dangers arising from exposure to ionising radiation | active | 15, 15.1, 15.2 | Link |
| Regulation (EU) 2023/1542 (Battery Regulation) | Regulation concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020, repealing Directive 2006/66/EC | active | 10 | Link |
| Regulation (EU) 722/2012 (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 | active | 10, 13 | Link |
| Regulation (EU) 2024/2847 (Cyber Resilience Act) | Regulation on horizontal cybersecurity requirements for products with digital elements (CRA) | active | 17, 18 | Link |
| Directive (EU) 2022/2555 (NIS2) | Directive on measures for a high common level of cybersecurity across the Union (NIS 2 Directive) | active | 17, 18 | Link |
| Regulation (EU) 2024/1689 (AI Act) | Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) | active | 17 | Link |
| Regulation (EU) 2023/988 (GPSR) | General Product Safety Regulation | active | 1, 3, 4 | Link |
| Regulation (EU) 2024/1781 (ESPR) | Regulation establishing a framework for setting ecodesign requirements for sustainable products (Ecodesign for Sustainable Products Regulation) | active | 10, 10.4 | Link |
| Regulation (EU) 2025/40 (PPWR) | Regulation on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC | active | 11 | Link |
| Directive 2014/53/EU (RED) | Radio Equipment Directive - harmonisation of the laws of the Member States relating to the making available on the market of radio equipment | active | 14 | Link |
| Regulation (EU) 2023/1230 (Machinery Regulation) | Regulation on machinery and repealing Directive 2006/42/EC | active | 1, 3, 9, 14 | Link |
| Directive 2001/83/EC (Medicinal Products) | Directive on the Community code relating to medicinal products for human use | active | 12 | Link |
| Directive (EU) 2022/2557 (CER Directive) | Directive on the resilience of critical entities | active | 17 | Link |