Tuesday, July 16, 2019

Market Surveillance and Compliance of Products

New EU Regulation (EU) 2019/1020 on Market surveillance and product compliance.

Original news posted by NIST. As mentioned in the NIST TEL MRA team release

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

Given that most readers of my posts will be impacted I have copied the release for re-circulation here.


Dear Colleagues:

Important Dates:
  • Enters into force on July 16, 2019 (20 days after publication in the OJEU)
  • Clauses regarding the establishment of the “Network” and funding apply as of January 1, 2021
  • Remaining clauses apply as of July 16, 2021

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

Key Provisions

  • 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)

See the attached document (or the link above) for further details. 

In the News  

Thank you.

Kind regards,