Responsible person for the technical file, Regulation 2019/1020.

EU Regulation 2019/1020 contains the latest provisions on market surveillance and product compliance. The Regulation justifies the tightening of measures by the fact that the internal market is intended to provide more opportunities for citizens and businesses, and the Commission seeks to improve monitoring and market access for non-compliant products. Market surveillance is mainly carried out ex post, i.e. on the basis of risk assessment and selectively, only after the product has already entered the market.

Improving the effectiveness of market surveillance does not necessarily create more opportunities for businesses, but in practice restricts and develops their activities due to stricter controls. However, effective market surveillance contributes to product safety.

Improving the effectiveness of market surveillance allows non-compliant products to be withdrawn from the market. It would be advisable to further improve the effectiveness of market surveillance so that products are checked before they enter the market, and product information should be more complete when making purchasing decisions.

Market surveillance could be more effective for both consumers and companies placing products on the market if it focused on checking products for compliance with established requirements before an importing company decides to purchase them. However, such activities would require greater financial support, which would be directed towards preventive rather than retrospective actions.

Regulation 2019/1020 states that the Commission aims to simplify the overall legislative framework for product regulation. Provisions relating to all goods placed on the market should be consolidated and a single legislative framework should be established.

Regulatory compliance and corporate responsibility ‘Regulatory compliance means meeting requirements,’ and in an organisation, this means conducting business in an ethical and responsible manner in addition to complying with laws, regulations and standards.

Regulatory compliance can be incorporated into an organisation's values and principles.

Regulatory compliance functions can be used to support an organisation in identifying and managing risks.

EU Regulation 2019/1020 on market surveillance and conformity assessment came into force in 2021.

The Regulation takes into account, among other things, that when placing products on the EU market, the relevant company must also have a representative registered in the EU who keeps technical documentation proving compliance (CE Marking) with the requirements.