White Paper: The New EU IVDR: Practical Implications for Manufacturers

The new European Union In Vitro Diagnostic Medical Device Regulation (IVDR) was approved by the European Parliament on 5 April 2017 and published in the Official Journal of the European Union on 5 May 2017. This new regulation will repeal Directive 98/79/EC as well as Commission Decision 2010/227/EU. It will have binding legal force throughout the EU and will be implemented in all member states simultaneously.

It is imperative that manufacturers understand the full impact of the IVDR on their business and do not delay in developing a strategy to ensure compliance.

This white paper covers:

  • Significant changes in the IVDR and implications for manufacturers
  • Important practicalities of implementation, including timelines
  • Steps manufacturers should take now
  • A programmatic approach to compliance
IVD manufacturers of all types and sizes can benefit from the clear direction and unique insights presented in this paper. Fill out the form to download your copy today.

Fill out the form to download the white paper