CE Marking CE Marking
 

Overview


Before products can be placed on the market within the European Union, a company must meet the requirements of any relevant product directives.   Following are examples of key product directives and what is required for compliance:

Medical Device Directive – 93/42/EEC

  • Technical File:   Technical documentatin must be prepared demonstrating the product’s compliance with the applicable essential requirements and conformity assessment procedures of the directive.
  • Registration of the device with the appropriate Competent Authority.
  • CE Certificate (device-specific) must be received from a Notified Body unless the device is classified as Class I.
  • Monitoring & Accident Reporting:  Systems must be established to monitor products on the market, and if accidents occur, to report to appropriate authorities.

Electromagnetic Compatibility (EMC) Directive – 2004/108/EC

  • Technical File:   Must contain product technical data and test reports demonstrating compliance with radiated emissions limits and susceptibility limits of defined EMC standards.
  • Declaration of Conformity that ensures a specific product meets all applicable compatibility provisions of the Directive.

Toy Safety Directive – 2009/48/EC

  • Technical File:   Must contain product description and use information, manufacturing process and product packaging information, test reports and product traceability information.
  • Declaration of Conformity that ensures a specific product meets all applicable safety provisions of the Directive – including documentation of self-verification or third party verification (depending on the applicable Module).
  • Safety Assessments to identify potential hazards must be conducted.
  • This is a revision to the previous Toy Safety Directive and compliance to its new measures must begin by July 20, 2011.
  • It applies to toys defined as “products designed or intended, whether or not exclusively, for use in play by children under 14 years of age.” 
 

Regulations & Standards


 Document Description Comments
CE Marking Before medical products can be placed on the European market, they must meet the requirements of the relevant European Economic Community product Directive. These Directives define product classification/requirements, certification, post-market monitoring, incident reporting and other CE Marking requirements. For more information:
EMC Directive This EMC Directive link brings up a summary page with a link to the directive itself and additional guidance documents related to compliance.  To access the Directive::
Toy Safety Directive
This link brings up a summary page with a link to the directive itself at the bottom of the page.  Also available from this page is a link to additional guidance documents related to the Toy Safety Directive.  To access the Directive:
Medical Devices
- Quality Management Systems -
Requirements for Regulatory Purposes
ISO 13485:2003 requirements are specific to medical devices and exclude some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, a firm’s quality management systems may conform to ISO 13485, but may not necessarily conform to ISO 9001. For more information:
Risk Management is considered essential for ensuring the safety and reliability of medical devices by both ISO 13485:2007 and the FDA QSR. ISO 14971 is specifically referenced within ISO 13485 and is recognized by the FDA as an acceptable risk management model.
 

Related Tools & Topics


 Document Description Comments
The Global Harmonization Task Force (GHTF) has assumed the leadership position for international harmonization in the regulation of medical devices. This site provides informative guidance on quality systems, auditing and risk management, among other topics.
Although the document is several years old, and has not been updated, it still provides an interesting overview of the global medical device market with respect to the top producers, consumers, emerging markets and evolving regulatory climate.