CE Marking

This article provides an analysis of the steps that manufacturers and distributors can take now to help ensure their continued access to the markets in the 27 remaining European Union Member States (EU-27) following the exit of the United Kingdom on 30 March 2019.

The CE marking is also called a “product’s passport” for the markets within the European Economic Area (EU Member States plus Liechtenstein, Iceland and Norway) and in Turkey. It is the first indication that a product complies with the requirements under European Product Law.

The European Commission, the executive body of the European Union, published its latest “Guide for the EMC Directive.”1 Updated to reflect the 2014 recast of the Directive, the Guide discusses various issues, not least what constitutes “inherently benign equipment” and “custom built evaluation kits.” This article reviews the content of the new Guide, highlighting key changes from the previous edition of the Guide published in 2010.

This article offers an alternative to the CB route of compliance to meet the new European safety standard EN 62368-1, Audio/video, information and communication technology equipment - Safety requirements, for equipment having an existing IEC 60950-1 CB certification.

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.