IVDR implementation by 2022 'highly doubtful,' trade group warns

Dive Brief:

MedTech Europe has again urged the European Commission to rethink the implementation of the In Vitro Diagnostic Regulation in light of the ongoing coronavirus pandemic.
In a position paper published Thursday, the trade group asked the EC to urgently start talks about contingency plans for IVDR, including a delay to the current 2022 date of application.
MedTech Europe contends "timely implementation" of IVDR by May 2022 is "highly doubtful" due to a number of issues including a shortage of notified bodies and the focusing of resources in response to COVID-19.

Dive Insight:

The European Union bowed to pressure to delay the Medical Device Regulation earlier this year, but retained the May 2022 date of application for IVDR. Since then, MedTech Europe has pushed for a delay to IVDR, citing the impact on COVID-19 activities and the deferral of MDR to make its case.

MedTech Europe made its latest push for change in a position paper that calls for EU authorities to "strongly" consider various solutions. The trade group wants the authorities to enter into an "urgent and open discussion" with the industry about contingency plans to inform the creation of "a clear, updated IVDR implementation" plan. MedTech Europe wants to see the plan as soon as possible.

The position paper proposes three actions the EU could take to improve the situation. MedTech Europe wants the EU to extend the IVDR grace period to cover more tests, as it did for MDR late last year.

That action could be combined with a "phased IVDR implementation combined with immediate strengthening of the existing IVD Directive." MedTech Europe said the strengthening of the directive could enable the EU to realize some benefits of IVDR before it has the infrastructure to implement the regulation. The trade group also proposed postponing the May 2022 date of application.

MedTech Europe cited four challenges to make its case for change, starting with the claim that the pandemic has "derailed ongoing IVDR implementation." As MedTech Europe sees it, the focus of regulatory agencies, laboratories and test manufacturers on COVID-19, coupled with disruption caused by lockdowns, have set back preparations for IVDR.

From MedTech Europe's perspective, the "practical deadline for the IVDR infrastructure to be fully established is not 2022, but 2020." MedTech Europe said manufacturers will need to file for certification of most IVDs by early next year to have the required clearances in place by May 2022. Failure to certify IVDs in time could cause "catastrophic disruption," according to the trade group.

MedTech Europe also said the infrastructure is unlikely to be in place in time, pointing to the lack of notified bodies, EU reference laboratories, common specifications and implementation guidance to make its case, while noting the MDR delay could exacerbate those problems.

"Since most authorities and several notified bodies are shared between MDR and IVDR, the reduction of the timeframe between the implementation of MDR and IVDR amplifies the already existing bottleneck in resources," MedTech Europe wrote.