Appointment of EU Representative – Compliance Request Form
Unified List of EU Directives and Regulations Requiring an EU Representative
The following is a comprehensive, unified list of EU directives and regulations that mandate the appointment of an EU representative (variously termed as EU Representative, Authorised Representative, Legal Representative, or Only Representative) for non-EU entities. This includes those relevant to IT, cybersecurity, data protection, digital services, product safety, medical devices, chemicals, and other areas.
Note that “directives” require transposition into national law, while “regulations” are directly applicable. The requirement typically applies to non-EU companies placing products/services on the EU market, processing data, or offering services without an EU establishment.
Directives & Regulations (as of August 30, 2025)
- General Data Protection Regulation (GDPR) – Regulation (EU) 2016/679
- Network and Information Systems Directive 2 (NIS2) – Directive (EU) 2022/2555
- Digital Services Act (DSA) – Regulation (EU) 2022/2065
- Digital Markets Act (DMA) – Regulation (EU) 2022/1925
- Artificial Intelligence Act (AI Act) – Regulation (EU) 2024/1689
- Data Act – Regulation (EU) 2023/2854
- Data Governance Act (DGA) – Regulation (EU) 2022/868
- Cyber Resilience Act (CRA) – Regulation (EU) 2024/2834
- General Product Safety Regulation (GPSR) – Regulation (EU) 2023/988
- Market Surveillance Regulation (MSR) – Regulation (EU) 2019/1020
- Medical Device Regulation (MDR) – Regulation (EU) 2017/745
- In Vitro Diagnostic Medical Device Regulation (IVDR) – Regulation (EU) 2017/746
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) – Regulation (EC) 1907/2006
- Batteries Regulation – Regulation (EU) 2023/1542
- Packaging and Packaging Waste Regulation (PPWR) – Regulation (EU) 2024/3618
- Waste Electrical and Electronic Equipment Directive (WEEE) – Directive 2012/19/EU
- Construction Products Regulation (CPR) – Regulation (EU) 305/2011
- Personal Protective Equipment Regulation (PPE) – Regulation (EU) 2016/425
- Appliances Burning Gaseous Fuels Regulation – Regulation (EU) 2016/426
- Noise Emissions Directive – Directive 2000/14/EC
- Machinery Directive – Directive 2006/42/EC
- Toy Safety Directive – Directive 2009/48/EC
- Ecodesign Directive – Directive 2009/125/EC
- Restriction of Hazardous Substances (RoHS) – Directive 2011/65/EU
- Pyrotechnic Articles Directive – Directive 2013/29/EU
- Recreational Craft Directive – Directive 2013/53/EU
- Simple Pressure Vessels Directive – Directive 2014/29/EU
- Electromagnetic Compatibility Directive (EMC) – Directive 2014/30/EU
- Non-automatic Weighing Instruments Directive – Directive 2014/31/EU
- Measuring Instruments Directive – Directive 2014/32/EU
- ATEX Directive – Directive 2014/34/EU
- Low Voltage Directive (LVD) – Directive 2014/35/EU
- Radio Equipment Directive (RED) – Directive 2014/53/EU
Summary Table
| Directive / Regulation | Rule for Representative (Who Needs It) | Responsibilities of the Representative | Link to More Information |
|---|---|---|---|
| General Data Protection Regulation (GDPR) – (EU) 2016/679 | Non-EU controllers/processors offering goods/services to or monitoring EU individuals. | Act as contact for data subjects/authorities; maintain records; handle complaints/inquiries. | Link |
| Network and Information Systems Directive 2 (NIS2) – (EU) 2022/2555 | Non-EU providers of essential/important services (e.g., cloud, digital infrastructure) without EU establishment. | Liaison for authorities; ensure risk management, incident reporting, audits. | Link |
| Digital Services Act (DSA) – (EU) 2022/2065 | Non-EU intermediary service providers (e.g., platforms, hosting) targeting EU users. | Handle content moderation, transparency reports, complaints; cooperate with authorities. | Link |
| Digital Markets Act (DMA) – (EU) 2022/1925 | Non-EU gatekeepers (large digital platforms) without EU establishment. | Act as contact point; ensure fair practices, data portability; report compliance. | Link |
| Artificial Intelligence Act (AI Act) – (EU) 2024/1689 | Non-EU providers of high-risk AI systems or general-purpose AI models. | Verify conformity; keep documentation; cooperate on audits/incident reporting. | Link |
| Data Act – (EU) 2023/2854 | Non-EU manufacturers/providers of connected products/services (e.g., IoT). | Ensure data access/sharing; handle user/authority requests; maintain documentation. | Link |
| Data Governance Act (DGA) – (EU) 2022/868 | Non-EU data intermediaries/altruism organizations offering services in EU. | Register with authorities; ensure neutral sharing; handle complaints. | Link |
| Cyber Resilience Act (CRA) – (EU) 2024/2834 | Non-EU manufacturers of products with digital elements (e.g., software, IoT). | Verify CE marking/conformity; handle vulnerability reporting; market surveillance cooperation. | Link |
| General Product Safety Regulation (GPSR) – (EU) 2023/988 | Non-EU manufacturers/sellers of consumer products (e.g., electronics) without EU operator. | Verify safety compliance; keep documentation; cooperate on risks/recalls. | Link |
| Market Surveillance Regulation (MSR) – (EU) 2019/1020 | Non-EU sellers of consumer products via e-commerce without EU importer/distributor. | Ensure directive compliance (e.g., CE marking); address non-compliance; authority liaison. | Link |
| Medical Device Regulation (MDR) – (EU) 2017/745 | Non-EU manufacturers of medical devices. | Liaison with authorities; support registrations; keep technical files; incident reporting. | Link |
| In Vitro Diagnostic Medical Device Regulation (IVDR) – (EU) 2017/746 | Non-EU manufacturers of in vitro diagnostics. | Similar to MDR: verify conformity; documentation; authority cooperation. | Link |
| Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) – (EC) 1907/2006 | Non-EEA exporters of substances/mixtures/articles (e.g., in electronics). | Register with ECHA; provide safety data; maintain importer inventory. | Link |
| Batteries Regulation – (EU) 2023/1542 | Non-EU manufacturers of batteries/portable batteries. | Ensure conformity; labeling; extended producer responsibility; authority cooperation. | Link |
| Packaging and Packaging Waste Regulation (PPWR) – (EU) 2024/3618 | Non-EU producers of packaging. | Verify compliance; handle extended producer responsibility; reporting. | Link |
| Waste Electrical and Electronic Equipment Directive (WEEE) – 2012/19/EU | Non-EU producers of electrical/electronic equipment. | Register; ensure collection/recycling; financial guarantees; reporting. | Link |
| Construction Products Regulation (CPR) – (EU) 305/2011 | Non-EU manufacturers of construction products. | Verify DoP/conformity; keep documentation; authority cooperation. | Link |
| Personal Protective Equipment Regulation (PPE) – (EU) 2016/425 | Non-EU manufacturers of PPE. | Verify conformity; documentation; labeling; risk handling. | Link |
| Appliances Burning Gaseous Fuels Regulation – (EU) 2016/426 | Non-EU manufacturers of gas appliances. | Verify conformity; keep technical docs; cooperate on surveillance. | Link |
| Noise Emissions Directive – 2000/14/EC | Non-EU manufacturers of outdoor equipment. | Verify noise conformity; labeling; authority liaison. | Link |
| Machinery Directive – 2006/42/EC | Non-EU manufacturers of machinery. | Verify safety/conformity; documentation; risk assessment. | Link |
| Toy Safety Directive – 2009/48/EC | Non-EU manufacturers of toys. | Verify safety standards; keep DoC; trace/supply chain. | Link |
| Ecodesign Directive – 2009/125/EC | Non-EU manufacturers of energy-related products. | Verify energy efficiency; documentation; market surveillance. | Link |
| Restriction of Hazardous Substances (RoHS) – 2011/65/EU | Non-EU manufacturers of EEE. | Verify substance restrictions; DoC; authority cooperation. | Link |
| Pyrotechnic Articles Directive – 2013/29/EU | Non-EU manufacturers of pyrotechnics. | Verify conformity; labeling; documentation. | Link |
| Recreational Craft Directive – 2013/53/EU | Non-EU manufacturers of watercraft. | Verify design/safety; keep docs; authority liaison. | Link |
| Simple Pressure Vessels Directive – 2014/29/EU | Non-EU manufacturers of pressure vessels. | Verify conformity; documentation; risk handling. | Link |
| Electromagnetic Compatibility Directive (EMC) – 2014/30/EU | Non-EU manufacturers of electrical equipment. | Verify EMC conformity; DoC; cooperation. | Link |
| Non-automatic Weighing Instruments Directive – 2014/31/EU | Non-EU manufacturers of weighing instruments. | Verify accuracy/conformity; documentation. |
