EU Shuffles IVDR Implementation Plan but Sticks to May 2022 Start Date
As you may know if your laboratory does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). Those implementation plans had to be put on hold due to the COVID-19 pandemic. But on June 7, the European Commission’s (EC) Medical […]
As you may know if your laboratory does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). Those implementation plans had to be put on hold due to the COVID-19 pandemic. But on June 7, the European Commission’s (EC) Medical Device Coordination Group (MDCG) unveiled a new joint IVDR implementation and preparedness plan (Plan). Here is a compliance briefing on the Plan.
Diagnostics Device Regulation in Europe
In April 2017, the EC and the European Parliament adopted the EU legislative framework for regulation of medical devices, comprised of two parts: i. the new medical devices regulation (MDR); and ii. the IVDR. The plan was for the MDR to apply starting in May 2020, to be replaced by the IVDR in May 2022. But things did not go as planned. In response to the pandemic, the MDR was postponed to May 26, 2021; but the May 2022 implementation date/compliance deadline for the IVDR was not postponed.
To make the transition and prepare for compliance with the IVDR, labs, authorized representatives and other stakeholders must carry out major operational tasks such as revising documentation about their products, recruiting new staff and updating internal procedures. While achieving all of this would have been tough even in normal times, transition at a time of pandemic created extra challenges. Thus, while a few have gotten ahead of the compliance curve, a vast number of laboratories are playing a desperate game of catchup.
The IVD industry has been sounding the alarm about preparations for incoming regulation for over a year. One of the biggest concerns is the limited number and capacity of so-called Notified Bodies (NBs) who are responsible for certifying all of the diagnostics that need to be assessed for the first time by May 2022.
What the Plan Says
Until now, the MDCG has remained determined to stick with the May 2022 deadline. But the new Plan is designed to offer some relief. The MDCG acknowledges the challenges laboratories and other stakeholders face in meeting the May 2022 deadline. The Plan outlines a new plan for IVDR based on a reassessment of the implementation priorities undertaken as of September with the objective of getting some kind of operational system in place before May 2022.
The Plan splits the listed priorities into two sets:
- Set A includes actions vital for devices to have access to the market, including those related to a framework for contingency planning, the availability of NBs and the designation of EU reference laboratories; and
- Set B includes legislation and guidance documents that, although not obligatory, are expected to facilitate the stakeholders’ and actors’ work.
The Plan lists priority actions to be carried out by the 27 member states and the EC and monitored at the MDCG level. It emphasizes the urgent need for scaling up all efforts across the board and collaborating.
While the EC has softened its position somewhat, it remains determined to transition to IVDR by May 2022. That may not prove realistic, especially since the COVID-19 factor remains very much in play. “We may be faced with a deterioration of the COVID-19 crisis or with a new health crisis around May 2022, when the actors have relatively little experience with applying the new framework and not all guidance is fully developed,” the EC acknowledges.
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