IVDR transition project

The company “CancerFighter” has developed and sells on EU market a blood IVD test called “CancerDetector” that detects a cancer specific biomarker. The IVD test is intended to be used as an aid for the diagnosis of cancer and is intended to be use by health professionals.  CancerDetector is currently self-certified in EU under IVDD and the company has already a certified Quality Management System (ISO 13485:2016).

CancerFighter initiates its IVDD to IVDR transition by conducting the following activities:

  • The top management, including the RA&QA Manager, participate into a training delivered by Medidee building a thorough understanding of the timelines and the requirements related to the IVDR transition in terms of update of the Quality Management System and Technical Documentation.
  • Following the training, the RA&QA Manager performs a re-classification of CancerDetector test according to Annex VIII of the IVDR. The IVD test will be classified as class C. This classification is checked by Medidee.
  • Based on the re-classification of the IVD product, the RA&QA Manager identifies the new assessment route for the EU registration of the IVD test. For its Class C IVD product, CancerFighter needs an assessment of its Quality Management System and as well as of its Technical Documentation (Annexes IX to XI of the IVDR). It means that under the IVDR, additionally to the QMS certification, CancerFighter will also need an assessment of the Technical Documentation by a Notified Body. This process is supported by a specialized Medidee expert.
  • A gap analysis on 1) the Quality Management System and on 2) the existing Technical Documentation (Annex II and III of IVDR) is conducted by Medidee in order to evaluate compliance with IVDR and to identify gaps that need to be filled. Different requirements related to Post Market Surveillance, Post Market Performance Follow-up, Performance Evaluation, and requirements based on Common Specification are identified. Based on the findings, an Implementation/Transition Plan taking into account timelines and staffing needs is presented to the top management. During this phase, the impact of the transition in terms of business and existing contracts with Economical Operators is assessed.
  • During the execution of the plan, the RA&QA Manager informs the current Notified Body of the re-classification of the CancerDetector test, assess its ability to conduct Technical Documentation assessment under IVDR and ask for their commitment. If the current Notified Body is unable to conduct assessment of the Technical Documentation under IVDR, the RA/QA Manager selects a new Notified Body (for the transfer of both, the QMS certification and Technical Documentation Assessment). Medidee supports the selection of the Notified Body.

Medidee asures a safe and effective transition by the mean of the adequate customised mix of strategic, tactical and hands-on support.