Post-Market Surveillance

The EU requirements concerning the marketing of products — from toys to construction products and electrical equipment — aim to ensure users’ safety. Ensuring compliance is an ongoing process, which includes post-market surveillance activities.

Thus, the manufacturer shall continue collecting information related to the use of its products after they have been marketed.

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. Regarding Post-Market Surveillance, the manufacturer shall:

  • Keep the technical documentation, declaration of conformity and where relevant notified body certificate for 10 years after it has placed the product on the market;
  • Maintain the technical documentation up to date to reflect the modifications to the product;
  • Ensure traceability of products placed on the market;
  • Implement procedures for series production to remain in conformity that take into account the changes in the product’s design or characteristics, and updates to harmonised standards and technical specifications;
  • Stay updated on new requirements and legislative changes;
  • Cooperate with competent national authorities (CA) in case dangerous or non-compliant products are placed on the market;
  • Provide on request CA with all information necessary to demonstrate the conformity of a product;
  • Bring non-compliant products into conformity;
  • Take corrective measures if non-conformities arise- such as the recall of irregular batches;
  • Report promptly to the CA of Member States in which products are made available in situations of risk to health, safety, the environment or any other public interest protected by the applicable legislation. For GPSD products via the European Commission Product Safety Business Alert Gateway;
  • Record complaints, non-conformities and recalls;
  • Carry out sample testing of marketed products, when necessary;
  • Inform distributors, importers and the Authorised Representative about monitoring activities.

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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