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Regulatory Affairs

The new In Vitro Diagnostics Regulation (IVDR) poses new regulatory challenges to you as an IVD manufacturer.  The new risk classification now requires the involvement of a notified body in the conformity assessment of all in vitro diagnostic medical devices with the exception of Class A products. In particular for performance evaluations and clinical performance studies, the requirements have increased and include targeted planning and implementation. Futhermore, there will be an increased focus on post-market surveillance to ensure that product defects and rarely occurring risks are identified and remedied throughout the entire life cycle of the product.

We help you to meet these increased requirements and support you in

  • Planning and implementation of performance evaluation
  • Systematic literature review
  • Development of PMS and PMPF plans and reports
  • Review/revision of risk analyses and instructions for use


Contact your novineon specialist.

Phone: +49 7071 98979 – 129