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Market Surveillance Regulation (MAR) REGULATION (EU) 2019/1020 Article 4/1:
A product falling under specified EU harmonisation legislation can only be placed on the EU market if there is an economic operator established in the EU who takes on certain legally required responsibilities. That operator must:
Confirm that an EU declaration of conformity or declaration of performance, along with the necessary technical documentation, has been prepared.
Keep the required documents available for inspection by market surveillance authorities.
Respond to any reasoned request from an authority by supplying all information and documentation
Alert market surveillance authorities if they have good reason to believe the product poses a risk.
Cooperate with market surveillance authorities.
Medical Devices Industry - Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Cosmetics Industry - Regulation (EC) No 1223/2009
Machinery Industry - Machinery Directive 2006/42/EC
Electronics Industry - Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU)
Toys Industry - Directive 2009/48/EC
AI Industry - The AI Act (Regulation (EU) 2024/1689)
Construction products (Regulation (EU) No 305/2011)
Personal protective equipment (Regulation (EU) 2016/425)
Burning gaseous fuels (Regulation (EU) 2016/426)
Batteries and waste batteries (Regulation (EU) 2023/1542)
Raw materials (Regulation (EU) 2024/1252)
Energy-related products (Directive 2009/125/EC)
Pyrotechnic articles (Directive 2013/29/EU)
Recreational craft and personal watercraft (Directive 2013/53/EU)
Simple pressure vessels (Directive 2014/29/EU)
Electromagnetic products (Directive 2014/30/EU)
Non-automatic weighing instruments (Directive 2014/31/EU)
Measuring instruments (Directive 2014/32/EU)
Protective systems (Directive 2014/34/EU)
Radio equipment (Directive 2014/53/EU)
Pressure equipment (Directive 2014/68/EU)
Artifical intelligence (Regulation (EU) 2024/1689)
Forest-based Products (Regulation (EU) 2023/1115)
Food (Regulation (EC) No 178/2002) (As responsible business operators)
General Product Safety Regulation (GPSR) REGULATION (EU) 2023/988 Article 5:
Products made available on the EU market must be safe!
A product is considered safe if it does not present any risk, or only minimal risks that are acceptable and consistent with a high level of protection for the health and safety of consumers. The product’s safety is determined by considering, for example:
The product’s characteristics (design, composition, packaging, instructions, etc.).
The effect of the product on other products, and vice versa.
The way the product is presented, its labelling, warnings, and instructions for safe use.
The categories of consumers likely to use it, especially vulnerable groups like children, older people, or persons with disabilities.
Appointment of Authorised Representative
Non-EU manufacturers are required to appoint an authorised representative located in the EU to ensure regulatory compliance.
Compliance with EU Regulations
Non-EU manufacturers are required to comply with EU regulations.
Maintenance of Technical Documentation
Non-EU manufacturers are required to keep technical documentation and cooperate with EU authorities.