On 25 June 2019, the EU published Regulation 2019/1020 on market surveillance and compliance of products. The Regulation is part of the Goods Package from 2017, combining legal proposals aimed to strengthen compliance with and enforcement of EU product legislation and to improve and facilitate the use of mutual recognition in the Single Market.
The purpose of the Market Surveillance Regulation is to improve product compliance controls at the borders of EU by:
- Providing rules and procedures for economic operators
- Strengthening market surveillance of products covered by EU harmonisation legislation
- Presenting a framework for controls at the EU border.
The Regulation enhances the powers of national market surveillance authorities to ensure effective market surveillance of products subject to Union harmonisation legislation sold offline and online in the respective territories. This harmonisation legislation includes Regulations on medical devices. However, pursuant to the principle of lex specialis, the new Market Surveillance Regulation applies only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. In other words, the new Market Surveillance Regulation governs only issues not already falling within the scope of the provisions of the MDR or IVDR in terms of objective, nature or effect. Furthermore, the new Regulation will affect the interpretation of the corresponding rules in the MDR and IVDR.
Pursuant to the Market Surveillance Regulation, market surveillance authorities must conduct appropriate checks of products, including appropriate physical and laboratory checks. It is important that the selection of products to be checked for compliance follow a risk-based approach which has regard to, among other factors, any possible hazards linked to the products' history of non-compliance and consumer complaints. Further, the Commission may adopt uniform rules for checking products where specific risks have been continuously identified. It is noteworthy that products deemed to be non-compliant in one Member State are, generally, presumed to be non-compliant in other Member States.
The Danish Safety Technology Authority has been appointed as the Danish market surveillance authority.
The Regulation applies from 16 July 2021. Click here to view the Regulation.