On 26 May 2021, several organisations within the pharmaceutical industry published a press release expressing concern over the current plan for IVDR implementation.
Regulation 2017/745 on medical devices (MDR) became effective on 26 May 2021. On the same date, the two industry organisations the European Federation of Pharmaceutical Industries and Associations and the European Cancer Patient Coalition issued a press release concerning the planned implementation of Regulation 2017/746 on in vitro diagnostics (IVDR), scheduled for May 2022.
Lack of notified bodies
In the press release, the pharmaceutical industry expresses its concern as to the lack of notified bodies that is expected to arise after the implementation of IVDR in May 2022. Following implementation of IVDR, the work load for notified bodies is expected to increase by 700%. According to the pharmaceutical industry, this is disproportionate to the current number of notified bodies for IVDR, which to date is only four bodies.
Moreover, there is a risk that the implementation schedule for IVDR indirectly may have an adverse impact on other aspects of the healthcare system. More specifically, the pharmaceutical industry points out that access to biomarker testing may be interrupted. Biomarker testing of cancer patients is a presumption for access to innovative and life-saving precision medicine. The press release refers to a case study that determines that this access will be significantly reduced as a result of the implementation of IVDR.
The press release also included a letter addressed to the Medical Devices Coordination Group (MDCG). In the letter, a group of stakeholders recommends a one-year postponement of the IVDR date of application with immediate effect. They also suggest a phased IVDR rollout that prioritises notified bodies' assessment of high-risk impact diagnostic tests.
Concern in Danish industry organisations
The two Danish industry organisations, Medicoindustrien and Dialab, also express their concern as to the time frame for IVDR implementation. The two industry organisations also base their concern on the lack of notified bodies. On this background, they sent a letter to the Danish Minister of Health, Magnus Heunicke, urging the Minister to address the situation at a meeting of the EPSCO council on 15 June 2021.
Unsuccessful call for action
Thus far, the recommendations for postponement do not seem to result in any changes. The day after the EPSCO council meeting, the European Commission published its implementation plan for IVDR, from which it appears that the EU upholds IVDR implementation in May 2022, despite the recommendations from various industry organisations to postpone.
It appears from the implementation plan that the immense work load that still needs to be carried out prior to final implementation is being recognised. The plan also includes a schedule for the implementation and designation of the parties responsible for the various elements of the implementation. However, the time of implementation is maintained, and the IVDR will take effect in May 2022.
Read more about the newly released implementation plan here.