New European regulation for better control of marketed products

Brexit and the UK General Election may have a longer term effect on a new ruling by the EU, who recently approved a new regulation (EU) 2019/1020 ("Requirements to the CE Mark, Criteria for appointing and operation of Notified Bodies and Market Authorities"). This amends the Directive 2004/42/EC plus the Regulation (EC) 765/2008 and (EU) 305/2011 concerning control of products entering the European market.

Why has it been introduced?

  • Volume of illegal and dangerous products
  • Majority of non-compliant products coming from outside Europe
  • Inefficient market surveillance and cross-border coordination
  • Online shopping with products going directly from manufacturer to consumer and, effectively, potentially bypassing compliance checks

What are the main changes?

  • Extending/specifying the role of the European representative. Must be established within the EU/EEA, have responsibility for the compliance documentation and be identified with contact details, on or with the product. Same applies for online shopping.
  • Extending/specifying the role of customs at borders. Stop products that are not marked or labelled correctly, including CE Marking and identification of European representative. Establish a network for coordination between the market surveillance authorities in member states.

The new regulation will come into force from 16 July 2021. Only time will tell how effective it will be!

We will keep customers informed of how any Brexit outcomes further affect these expectations, but don't hesitate to contact us if you have any questions.

Tags: EMC Directive , CE Marking

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