European Directives

The Low Voltage Directive 2014/35/EU replaced the Low Voltage Directive 2006/95/EC

  • Date: April 20, 2016
  • Scope: changed
  • Technical requirements: unchanged
  • Documentation requirements: changed.

The current version of the LVD requires, among other things, a differently formatted EU declaration of conformity and a contractual understanding between the manufacturer and importer regarding the handling of the Technical File.

The EMC Directive 2014/30/EU replaced the EMC Directive 2004/108/EC

  • Date: April 20, 2016
  • Scope: changed
  • Technical requirements: unchanged
  • Documentation requirements: changed.

In the current version of the EMC Directive, the Technical documentation (TF) requirements have increased in the amount and complexity of necessary information. Notably, the technical documentation makes a requirement for a risk assessment which will affect the compliance process if the product is not within the scope of the Low Voltage Directive or the Machinery Directive.

The Radio Equipment Directive (RED) 2014/53/EU replaced the R&TTE Directive 1999/5/EC

  • Date: June 13, 2016 (R&TTE equipment could be supplied until June 12, 2017)
  • Scope: changed
  • Technical requirements: unchanged
  • Documentation requirements: changed.

The RED changes the Technical documentation (TF) requirements by increasing the amount and complexity of necessary information, including a statement by the manufacturer regarding the impact of the equipment on the radio spectrum in the locale of the end-user.

The ATEX Directive 2014/34/EU replaced the ATEX Directive 94/9/EC

  • Date: April 20, 2016
  • Scope: changed
  • Technical requirements: unchanged
  • Documentation requirements: changed.

The current version of the ATEX Directive requires ATEX certificates, necessitated by the change in wording in the new Directive.

The Machinery Directive 2006/42/EC replaced Machinery Directive 98/37/EC

  • Date: December 29, 2009
  • Scope: changed
  • Technical requirements: changed
  • Documentation requirements: changed.

The current version of the Machinery Directive is about improving machinery design while building it correctly, so it is safely used.

 

The Medical Device Regulation (MDR) will be replacing Medical Device Directive (MDD) (93/42/EEC and Active Implantable Medical Devices (90/385/EEC)

  • Date: Entered into force on May 26, 2017. Still in the transition period, which was extended due to COVID 19. The new date of application is May 26, 2021.
  • Scope: changed
  • Technical requirements: changed
  • Documentation requirements: changed.

There are many differences between MDR and MDD.

Some of those differences include:

  • Addressing legacy devices, that were CE marked under the MDD.
  • Updating clinical data, labeling, and technical documentation.
  • Some devices previously exempt from MDD will now fall under the MDR, as the definition of a medical device will be broadened.
  • Many medical devices will need to be reclassified.
  • A Unique Identification Number (UDI) will be implemented to help track devices.

F2 Labs has studied the European Directives.  We are here to help you and can answer questions about your specific project.

Please feel free to contact us if you have any questions regarding these updates.

We’re here to help.

 

Contact one of our representatives today
to inquire about a quote from F2 Labs
or call us today at 877-405-1580

Request a Quote Have a Question?

F2 Labs
Copyright © 1991 - 2021. All Rights Reserved.