New European Regulation for better control of marketed products

The European Parliament and Council approved a new European Regulation (EU) 2019/1020 (“Requirements to the CE-Mark, Criteria for appointing and operation of Notified Bodies and Market Authorities”) on 20 June 2019. This amends the Directive 2004/42/EC plus the Regulations (EC) 765/2008 and (EU) 305/2011 concerning control of products entering the European market.

It covers all products under the EU sector-specific regulations, such as the Low Voltage Directive and the Medical Device Directive.

The reasons given for this new Regulation are:

  • Increased number of illegal and dangerous products
  • Majority of non-compliant products from outside Europe
  • Undue distortion of competition
  • Inefficient market surveillance and cross-border coordination
  • On-line shopping with products going directly from manufacturer to consumer

Some of the main changes are:

  • Extending/specifying the role of the European representative:
  • Must be established within EU/EEA, have responsibility for the compliance documentation, and be identified with contact details, on or with the product
  • Same rules apply 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 network for coordination between the market surveillance authorities in the member states

 

The new Regulation shall be in force from 16 July 2021.

 

For more information, please contact JonIvar.Tidemann@nemko.com