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