New EU Regulation on Market Surveillance and Product Compliance

The Official Journal of the European Union publishes the new EU regulation on market surveillance and the compliance of products within the European Union.

The key provisions are as follows:

  • Establishes a new Union Product Compliance Network (Article 29) (referred to as the “Network”) that will coordinate Member States enforcement authorities and market surveillance authorities – Article 29
  • Gives the Commission the ability to designate Union Testing Facilities of its own or in a Member State - for testing of products – (48) and Article 21
  • Requires Member States to establish a single market surveillance liaison office – Article 10 (3)
  • Requires Member States to ensure that their market surveillance authorities have the right resources and powers
  • Allows Member States to give their market surveillance authorities power to require access to embedded software, reverse engineer products (and other powers) – Article 14 (4a and 4j)
  • Brings the “fulfillment service providers” into the list of economic operators – Article 3 (11)
  • For some products, requires that there be an economic operator established in the EU – this can be the manufacturer, the importer, an authorized rep, or the fulfilment service provider – See Article 4
  • In such cases, specific information must to be included on or with the product, including the contact details of the economic operator – Article 4 (4)
  • This does apply for products covered under the RED and EMCD – Article 4 (5)
  • Requires that “information society service providers” cooperate with market surveillance authorities for products being sold on-line - Article 7 (2)
  • Requires that the MS authorities take account of test reports or certificates issued by CABS accredited in accordance with 765/2008 as part of “checks”: - Article 11 (5)
  • Requires that Member States give economic operators at least 10 working days to be heard before a measure is taken if possible – Article 18 (3)
  • Gives Commission ability to approve of specific pre-export control systems established by third countries if there is “official” verification done by the third country – Article 35 (3) and (7)

This regulation enters into force on July 16, 2019 (20 days after publication in the OJEU).

These new regulations will impact most manufacturers/economic operators placing products on the market in the EU.

The full regulation can be found here.

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