Objectives of the IVD-R

  • Patient safety to ensure a high level of protection of human health and safety.
  • Free & fair trade to ensure the smooth functioning of the internal market.
  • Supporting innovation & competitiveness of the European medical devices industry.
  • Harmonization by all EU member states.

Main differences between IVD-D and IVD-R

  • Contrary to a Directive of which the interpretation can vary across EU member state, a Regulation is binding in all member states
  • The IVD-R introduces a classification revolution, with a shift from a prescriptive list to rule based device classification governed by the intended purpose.
    Click here for a clear overview of the classification rules  
  • The IVD-R calls for new conformity assessment routes depending on risk class – impact on product and Quality Management System.
    Where the IVD-D only required Annex II List A and B products to undergo Notified Body approval (~10% o f all IVD products), the IVD-R requires almost all products (except class A) to go via a Notified Body (~85% of all IVD products).

  • In the IVD-R the concept “Clinical Evidence”, which consists of Scientific Validity, Analytical Performance and Clinical Performance has been introduced.
    Scientific Validity ” is a new requirement, where a manufacturer must provide evidence for association of the analyte of a device with one or more clinical conditions or physiological states. Demonstrating scientific validity for established assays can be straightforward (e.g. from the scientific literature), however novel assays may require more data.
  • IVD-R also introduces a new version of EUDAMED, the European Database for Medical Devices. EUDAMED is at the heart of the traceability of devices. This database will consist of six modules and will gather information such as:
    • economic operators (manufacturers, authorized representatives, distributors and importers), identified via their  Single Registration Number (SRN).
    • devices and their  Unique Device Identification (UDI).
  • Risk management requirements have been elaborated in the IVD-R and must be integrated in different business processes e.g. design control, clinical performance, manufacturing, QC and PMS…
  • The IVD-R requires a new and more demanding approach for a comprehensive Post-Market Surveillance System (reactive and proactive), including, when applicable, 
    • New Vigilance reporting timelines (15 vs 30 days) that will radically change reporting practices
    • Periodic Safety Update Reports (PSURs). 
    • Post-Market Performance Follow-Up (PMPF) to continuously update performance evaluation data throughout the lifetime of the device.
    • Trending

In order to comply to the IVD-R manufacturers will have to update their device documentation, e.g. create the Technical Documentation as per Annex II and III, and draw up a Declaration of Conformity as per Annex IV.

Should you have questions on a specific topic or you need assistance to comply to IVDR, please contact us . 

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