Market Surveillance

Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products places specific focus on e-commerce and online trading, and it is applicable to online sellers across Europe.

The Regulation requires compliance for the following products: toys, electrical and electric equipment, machinery, construction products, personal protective equipment, consumer goods, vehicles and others.

Regulation (EU) 2019/1020 on Market Surveillance & Compliance of Products

All manufacturers need to designate an Authorised Representative established within the EU-27 to facilitate contacts with market surveillance authorities. The regulation has been applicable as of July 2021, and covers market surveillance of non-food products (‘’industrial products’’) whose placement on the internal market is subject to Union harmonizing acts. It lays out many novelties, such as:

  • Requires manufacturers to designate an Authorized Representative within the Union to facilitate contacts with market surveillance authorities;
  • Defines the ways competent authorities should cooperate;
  • Sets out Member States’ obligations regarding the organization of market surveillance within their territory;
  • Provides a set of powers for market surveillance authorities, such as the power to access data and documents, carry out on-site inspections, make test purchases, carry out mystery shopping, as well as withdraw products and destroy them, impose penalties and order the recovery of profits.
  • Introduces the possibility of designating Union testing facilities;
  • Sets the procedure for mutual assistance, in form of requests for information and requests for enforcement measures, and enables the use of evidence obtained in one Member State to be used in another one;
  • Strengthens the provisions for customs controls on products entering the Union market;
  • Establishes a Union Product Compliance Network within the Commission in order to coordinate enforcement tasks in Member States.

The aim of the Regulation is to oblige companies not established in the EU to appoint an economic operator within the EU, who will have far-reaching obligations to remedy non-compliance.

The framework for market surveillance established by this Regulation complements and strengthens the existing provisions in Union harmonization legislation relating to the ensuring of compliance of products.

This means that, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonization legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in the Cosmetics Regulation 1223/2009, Medical Device Regulation 2017/745, In-Vitro Devices Regulation 2017/746, Motor Vehicle Regulation 2018/858, etc.

As of July 16, 2021, you can only place a product on the EU market, if you:

  • Fulfil the essential requirements as stated by the legislation that applies to your specific product type; this has to be documented in the technical file (including the necessary testing etc.);
  • Designate an Authorized Representative established within the EU-27 who will be responsible to perform the tasks specified in the signed mandate as per the applicable EU legislation, for ex. keep available manufacturer’s technical documentation for inspections by the CAs.

It is important to designate an Authorized Representative, which must take place by signing a legal mandate (contract) by both parties.

In addition, for certain types of products, such as medical devices, it is crucial to designate a Person Responsible for Regulatory Compliance (PRRC) as well. This person must have the appropriate capabilities (resources, knowledge, competences, experience) to be able to fulfil their tasks.​

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