IVDD to IVDR: How to Successfully Make the Transition

 

The European Union’s In Vitro Diagnostic Regulation EU 2017/746 (IVDR) has been in place since 2017, and with it, has come new challenges for the IVD industry throughout Europe. Given the scale of the regulation’s proposed changes, a five-year transition period has been underway since its publication with the date of application (DOA) of 26 May 2022. Upon this obligatory conformity date, all IVD products must meet the new requirements, including non-application of CE marks under the superseded In Vitro Diagnostic Directive (IVDD).

 

What are the differences between IVDD vs IVDR?

There are several differences between IVDD and IVDR, but the most notable change is in how diagnostic medical devices are classified. The classification scheme of IVDD was based upon the type of pathogen or condition that the medical device was designed to diagnose, whereas IVDR determines its classifications based on what risk the device poses to the patient should it malfunction. This difference in classification allows IVDR to better accommodate new technologies and scientific advances, especially in response to new deadly pathogens and other emerging risks.

In addition to classification changes, there are several other ways IVDR differs from IVDD, including: changes in the conformity assessment for class B to D devices, stricter requirements for technical documentation, new software requirements, the introduction of unique device identification (UDI) numbers, new requirements for manufacturers to have a quality management system, and the appointment of a person responsible for regulatory compliance (PRRC).

 

How Can Manufacturers Ensure Compliance?

The length of the transition period hints at the scale of the challenge for all involved, from manufacturers, Notified Bodies (NBs), Competent Authorities (CAs), importers and distributors. However, what is it that manufacturers must do to become compliant with the IVDR, and where should they start?

Drawing from NAMSA’s lengthy experience of working with clients and NBs in Europe, the enclosed roadmap will provide manufacturers with a tool and a foundation to plan, execute and achieve IVDR compliance. Included within is an analysis and guidance for applying the IVDR to product development. This incorporates workflow diagrams and hyperlinks to relevant IVDR sections and annexes, in addition to the following information:

• The Four Stages of IVDR Compliance
• Planning and Strategy
• Planning and Strategy (Classification)
• Clinical Evidence and Technical Documentation
• Conformity Assessment and Registration
• Post-Market Surveillance (PMS)

Please fill out the form below to access the roadmap.

We also invite you to learn more about NAMSA’s IVD Services by clicking here.