Following hot on the heels of the EU Medical Device Regulation becoming applicable on 26 May 2021, multiple groups within the life sciences community, including a pharmaceutical industry body, have repeated the loud calls for a delay in implementing the In Vitro Diagnostic Regulation (IVDR). The IVDR is slated for application in the EU from 26 May 2022 and there is considerable concern that the necessary infrastructure for the regulatory step up will simply not be in place in just under a year’s time. Without intervention, the groups highlight the potential for serious disruptions in patient care, especially in targeted cancer therapies.
On the same day the EU MDR became applicable, the European Federation of Pharmaceutical Industries and Associations (EFPIA), together with the European Cancer Patient Coalition (ECPC) and Diaceutics (a precision medicine data analytics company) released a joint press release voicing concern. The press release singles out the paucity of Notified Bodies (NBs) that will be needed to cope with the estimated 700% increase in NB workload to assess in vitro diagnostics (IVDs). To date, only 4 NBs have been designated for IVDR. This is compared with 22 NBs under the current IVD Directive regime.
The press release emphasises not only the issues being caused directly by the current IVDR implementation plan but also the downstream effects on the wider healthcare ecosystem. Specifically highlighted is the potential interruption to biomarker testing access. Biomarker testing of cancer patients is required in order to them to access innovative and life-saving precision medicines. A case study referenced in the press release suggests that this could reduce significantly as a result of IVDR implementation.
A joint stakeholder letter addressed to the in vitro diagnostics working group of the European Medicines Agency’s Medical Device Coordination Group (MDCG) was issued together with the press release. This letter calls for a postponement to the current application date and a phased approach to the application of IVDR. As noted in previous articles and the stakeholder letter, the pandemic has resulted in further implementation problems, with on-site audits by NBs proceeding glacially.
The letter calls for:
- an initial one-year postponement of the IVDR date of application with immediate effect;
- a phased IVDR rollout prioritising NBs’ assessment of high-risk impact diagnostic tests (such as biomarkers), and
- accelerated designation of a sufficient number of NBs, release of key guidance and full functionality of the Eudamed database to ensure that crucial necessary infrastructure is in place come application day.
In our view, this latest warning call to the European institutions regarding IVDR implementation is notable due to the involvement of EFPIA, a pharmaceutical industry body. Previously we have seen medical device industry stakeholders sound the alarm bell but now a significant figure in the life sciences community is joining those calls. The revolutionary regulatory changes that IVDR will introduce must be recognised as having widespread ramifications for companies across the healthcare industry and not only those involved in the medical device industry.