IVDR - NEW EC REGULATION

The Regulation EU 2017/746 (IVDR) replaces the “positive list” approach with new classifications rules, as defined in Annex VIII. These classification rules define 4 different levels of risk classes (from the lowest risk class, i.e. class A, to the highest risk class, i.e. class D), based on the clinical risk profile of the IVD. As a result, all currently marketed IVDs and newly developed IVDs will need to be re-classified according to the new rules, and their conformity assessment re-defined based on the risk class.

The re-classification is expected having an unprecedented effect in the IVD industry, as most of currently self-certified marketed IVDs will need to be assessed for the first time by Notified Bodies in order to remain in the market. The estimated outcome of this process is a reversal of the current regulatory framework, i.e. moving from 80% of IVDs under self-certification according to IVDD to 80% of IVDs requiring the involvement of the Notified Body for assessing the conformity to IVDR.

Many manufacturers, which did not have in their product portfolio List A or List B IVDs, will have to contact for the first time a Notified Body, for Technical Documentation assessment of their re-classified IVDs and, possibly, for the first certification of their Quality Management System according to ISO 13485. Critical suppliers of these manufacturers will have to meet the additional requirements set by the IVDR, and may be exposed to unannounced audits by Notified Bodies. Distributors will have to follow the additional requirements set by the IVDR too.

On the other side of the fence, Notified Bodies designated under the IVDD are 22, and their internal resources have been sized to accommodate the need of a small portion of the IVD industry, i.e. the List A, List B and devices for self-testing, which corresponds to roughly 20% of the whole IVD industry. Hence, as a result of the shift in the classification of IVDs, the 22 Notified Bodies and their internal resources may already not be sufficient to meet the demand of about 80% of IVDs requiring the involvement of a Notified Body according to the new Regulation.

Furthermore, Notified Bodies need to be re-designated under the new Regulation, and in this process not necessarily all Notified Bodies will be able to maintain the same scopes, covering for all IVD applications. As of today, a limited number of Notified Bodies is designated under the new Regulation: the up-to-date list of IVDR designated Notified Bodies can be consulted in Nando section of the European Commission website.

Therefore, considering, on the one hand, the expected increase in the demand by the IVD industry for Notified Bodies and, on the other hand, the probably limited availability of Notified Bodies designated under the IVDR with a full scope, the bottleneck for the CE marking of currently marketed IVDs as well newly developed IVDs will indeed be the assessment of the Technical Documentation by Notified Bodies in order to receive the EC certificate.

Finally, according to Article 110 of the IVDR, a “soft” transition period is defined from May 2022 to May 2024 for IVDs which have placed in the market under the IVDD prior to May 2022 by virtue of an EC certificate.

However, most of the currently marketed IVDs do not hold an EC certificate, as they have been placed on the marked under self-certification. Therefore, as a secondary effect of the shift in the classification of IVDs, most manufacturers of IVDs will not be able to implement a “soft” transition up to 2024; instead they will need to apply in full the new Regulation starting from May 2022.

Medidee supports you in this transition with:

  • Re-classification of the IVD, and re-definition of the regulatory pathway for CE marking. Read here to find further details on the typical content of the Regulatory Pathway Report.
  • Identification and first communications with Notified Bodies;
  • Certification process of the Quality Management System in compliance to ISO 13485 (including QMS deployment, internal and/or supplier audits, and assistance during Notified Body audit). Read here how our experts can support you in your QMS.
  • Certification process of laboratories in compliance to ISO 17025, for companies providing testing services.
  • Review of the existing safety and performance data for compliance to the GSPR, as defined in Annex I of the IVDR;
  • When applicable, strategic planning for grouping, i.e. definition of product “families”, based on intended use and/or working principle of the IVD, to be implemented for the review process by the Notified Body.

Moreover, one of the major changes brought by the European In Vitro Diagnostic regulation is the requirement of a Performance Evaluation Report (PER). Medidee may:

 

  • Assess the completeness of the current available technical documentation (Analytical/Clinical (Scientific/PMPF)
  • Perform a review of literature (including the difficult organization of literature search) for state-of-the-art assessment and scientific validity substantiation,
  • Support the design of analytical performance and clinical performance studies,
  • Design of Post-Market Performance Follow-up plan (PMPF Plan)
    Medidee integrates a full scientific team ready to write your PER, including the difficult organization of literature search. Medidee may also review existing PER.