Implementation of new CE marking regulations


July 2018

The EU regulatory system for making medical technologies available to the EU market is undergoing a full revamp. In May 2017 the new Medical Devices Regulation (MDR) and the new In Vitro Diagnostic Medical Devices Regulation (IVDR) have been published. The regulations foresee a three (for MDs) and five-year (for IVDs) transition period in which all actors, such as EU and national authorities, hospitals, laboratories and manufacturers, all need to adapt and apply the new requirements that are set in the new rules.

Since day one, the medical technology industry invested heavily to comply with the new requirements. However, after 14 months into the transition periods industry has significant concerns about the state of implementation and the slow progress in putting into place the essential elements of the new regulatory systems needed for the approval of MDs and IVDs.

The industry is, therefore, calling urgently on EU policymakers to provide solutions that will rapidly install the functionality of the new regulatory systems. This should safeguard the continued availability of life-saving and life-transforming medical technology products.

Please read our new publications on this matter.

 

  1. Position Paper:  It stresses the industry’s growing concerns with the slow progress of implementation and includes a call for action to look for early enough solutions.

     
  2. Infographic on Notified Body situation: It conveys facts on Notified Bodies and explains the crunch time that they will be facing with impact on the overall approval system

 




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Our other position papers (published in November 2017).